At the 52nd meeting of the American Association of Physicists in MedicineAmerican Association of Physicists in Medicine (AAPM), which convenes from July 18 – 22, 2010 in Philadelphia, PA, thousands of scientists and board-certified health professionals will gather to share the latest developments in medical imaging and radiation therapy, examine new clinical and laboratory data, and discuss many of the ethical and regulatory issues that face the field today.

Preliminary highlights of the meeting are listed below.

1. PATIENT SAFETY: A Special Symposium
2. CANCER SURVIVAL: President’s Symposium Reveals One Patient’s Story
3. PEDIATRIC RADIATION DOSE: Method for Reducing Radiation Dose from imaging tests to Pediatric Populations
4. NANOTECHNOLOGY: Devices for Drug Delivery and Hyperthermia
5. CT RADIATION DOSE: Symposium on CT Dose Measurement and Reduction
6. BREAST CANCER: Reducing Skin Doses during Breast Brachytherapy
7. RADIATION IN UTERO: Assessing and Minimizing Radiation Dose on a fetus
8. MEDICAL WASTE: Medical Radionuclides in Wastewater
9. CANCER DETECTION: New Imaging Device for Tumor Detection
10. CLINICAL RESULTS: Radiation Treatment for Paranasal Sinus Tumors
11. NANOTECHNOLOGY: Symposium on Nanotechnology and Cancer
12. NEW STANDARDS: Measurement Standards for Brachytherapy
13. SAFETY: International Atomic Energy Agency “Smart Card” Radiation Dose Initiative
14. NEW DEVICE: Treatment Couch Tracks Tumors in Real-Time
15. GUIDELINES: Upcoming FDA Handbook on CT Dose
16. NEW TECHNOLOGY: Emerging X-ray Detector Technologies
17. SAFETY: New U.S. Nuclear Regulatory Commission Statement
18. COMPUTATIONAL TOOLS: A Web-based Dose Calculator
19. LICENSURE: Medical Physicists
20. FUNDING: New National Cancer Institute Initiatives

1. PATIENT SAFETY: A Special Symposium “The goals of the symposium will be to present the background to the recent increase in awareness and what the AAPM and international organizations are doing to improve patient safety.”
2. CANCER SURVIVAL: President’s Symposium Reveals One Patient’s Story “Professor Jim Donnelly is a head and neck cancer survivor and he will relate his unique perspective of the experience from symptoms, through diagnosis and treatment. His physician, Dr. Robert Foote, will provide the doctor’s point of view focused on an individual human being. We will see through the patient’s eyes how the technology and procedures we develop are perceived and how their use throughout the medical process contributes to the profound impact on everything in Jim’s life.”
3. PEDIATRIC RADIATION DOSE: Method for Reducing Radiation Dose from Imaging Tests to Pediatric Populations “To date, the combination of these efforts has led to an average reduction in dose of 23%. Additional approaches (adaptive statistical iterative reconstruction and organ shielding) are currently being evaluated and are expected to provide even greater dose-savings to our pediatric patients.”
4. NANOTECHNOLOGY: Devices for Drug Delivery and Hyperthermia “We developed a magnetic, nanoparticle-assembled capsule, which is a multifunctional device that can be used simultaneously for both controlled drug release and hyperthermia…”
5. CT RADIATION DOSE: Symposium on CT Dose Measurement and Reduction
6. BREAST CANCER: Reducing Skin Doses during Breast Brachytherapy “This project opens the possibility to increasing the survival expectancy and minimizing negative side effects during brachytherapy treatments, as well as improving cosmetic outcome for all [Accelerated Partial Breast Irradiation] patients. The proposed method may also be used in other procedures for brain, heart, rectal, or vaginal cancers…”
7. RADIATION IN UTERO: Assessing and Minimizing Radiation Dose on a fetus “This work introduces a new set of fetal computational phantoms to be used for use radiation dosimetry purposes… In the future, completed fetal phantoms may be combined with an adult female phantom to provide a powerful tool with which to simulate in utero internal and external medical radiation exposures.”
8. MEDICAL WASTE: Medical Radionuclides in Wastewater “Although research is ongoing it is conceivable that long lived impurities from nuclear medicine procedures could make it into municipal wastewater and possibly the environment.”
9. CANCER DETECTION: New Imaging Device for Tumor Detection “A novel tactile imaging device for tumor identification has been designed and experimentally evaluated to be effective.”
10. Clinical RESULTS: Radiation Treatment for Paranasal Sinus Tumors “Between May 2001 and June 2008, 31 patients with PNS malignancies were treated [at Fox Chase Cancer Center, Philadelphia, PA] with [Intensity-Modulated Radiation Therapy]…”
11. NANOTECHNOLOGY: Symposium on Nanotechnology and Cancer “We will describe the latest research and development in this exciting and rapidly advancing field. We will review newly developed cancer diagnostics and therapies, including the combination of imaging combined with drug delivery, based on nanotechnology and identify future directions.”
12. NEW STANDARDS: Measurement Standards for Brachytherapy National Institute of Standards and Technology (NIST) has “designed, constructed, and validated the experimental apparatus necessary for the measurement of air-kerma from an x-ray brachytherapy source using a primary standard.”
13. SAFETY: International Atomic Energy Agency “Smart Card” Radiation Dose Initiative “The concept of “radiation passport” or something similar has been around for over a decade but the current impetus is based on a) realization of increased radiation doses to individual patients in diagnostic and interventional procedures and b) possibility of electronic means to achieve tracking of procedures…”
14. NEW DEVICE: Treatment Couch Tracks Tumors in Real-Time “To characterize the performance of a novel treatment couch designed and developed for respiration-induced real-time tumor motion tracking and to investigate its behavior with real tumor trajectories…”
15. GUIDELINES: Upcoming FDA Handbook on CT Dose “The CT handbook will be a volume in a series promoting public health and radiation safety through publicly accessible dose information that could be used by medical staff to communicate risk and optimize protocols reducing dose….”
16. NEW TECHNOLOGY: Emerging X-ray Detector Technologies “The main topic of this Symposium talk is new development of selenium-based x-ray imaging detectors…”
17. SAFETY: New U.S. Nuclear Regulatory Commission Statement “NRC is in the process of updating and expanding its 1989 policy statement on safety culture to include the full range of NRC regulated activities and to better address security issues…”
18. COMPUTATIONAL TOOLS: A Web-based Dose Calculator “The growing interest in patient doses has led to more frequent requests for estimates of the dose imparted to patients by nuclear medicine procedures. A Web-based computer application has been developed to facilitate timely response to such requests and to enable easy access to dosage-specific dose estimates within our institution [M. D. Anderson Cancer Center in Houston].”
19. LICENSURE: Medical Physicists AAPM’s Professional Council Symposium will give an update on the licensure effort by the AAPM and the American College of Medical Physicists (ACMP); describe the Federal legislative climate and how it is influencing the issue; and discuss comprehensive registration — an alternative to licensure.
20. FUNDING: New National Cancer Institute Initiatives “NCI has initiated a number of new initiatives that are focused on the development of methods to develop and robustly validate current and next generation of imaging platforms…”

Source:
Jason Bardi
American Institute of Physics

Medtronic, Inc. (NYSE: MDT) announced availability of the company’s new Midas Rex® Legend® EHS Stylus Touch™ high-speed electric drill for spinal, cranial and orthopaedic surgical procedures. This is the first electric drill from Medtronic with integrated finger control and is based on the well-established Legend EHS Stylus® motor. With high torque and a compact size, the Legend EHS Stylus Touch drill offers excellent balance and maneuverability for procedures in tight anatomic spaces. Surgeons can operate the drill using finger control only, footpedal control or both.

“With almost 50 years of leadership and innovation in high-speed surgical drills, we’re excited to offer our newest Midas Rex drill for surgeons who prefer the convenience and familiarity of finger control,” said Darren Woodruff, product manager for Spinal Power with the Neurologic Technologies division at Medtronic. “The Legend EHS Stylus Touch doesn’t require a footpedal at all, which can be advantageous during multi-surgeon procedures and at busy trauma centers.”

Additional features of the Legend EHS Stylus Touch drill include:

- Ergonomic positioning and true variable speed adjustment
- Easy-to-use design and quick set-up
- Adjustable speeds from 200 to 75,000 RPM

The Legend EHS Stylus Touch drill is powered by Medtronic’s Integrated Power Console (IPC®) system, a multispecialty surgical power console that offers improved intraoperative functionality. With the IPC system’s intuitive touchscreen interface, surgeons can use saved custom settings, quickly adjust irrigation via simple remote control, and run multiple Medtronic handpieces.

As part of the standardized Legend platform, the Legend EHS Stylus Touch drill works with Medtronic’s interchangeable Legend tools and attachments for a broad range of surgical procedures.

“The Legend EHS Stylus Touch drill continues our tradition of innovative, powerful high-speed surgical drills, and is a direct result of listening to our customers’ needs,” said Bob Blankemeyer, president of the Surgical Technologies business and senior vice president at Medtronic.

About the Surgical Technologies Business at Medtronic

The Surgical Technologies business develops products for the diagnosis and treatment of chronic diseases and disorders of the ear, nose and throat; surgical devices and implantable products for the treatment of cranial, spinal and specialty small-bone conditions; and state-of-the-art navigation equipment used in operating rooms to assist physicians in neuro and spinal surgery procedures.

Source:
Medtronic

Authors
Jennifer Y. Dukart
Christin E. Garcia

This week, the United States Supreme Court agreed to review Matrixx Initiatives, Inc. v. Siracusano, a case presenting the question whether securities law plaintiffs must allege statistically significant evidence of harm to survive a motion to dismiss when bringing claims against drug companies for failure to disclose adverse event reports. Shareholders sued Matrixx, arguing that it violated § 10(b) of the Securities Exchange Act and SEC Rule 10b-5 by publicly affirming the safety of its nasal gel Zicam®, while knowing that 12 Zicam® users had reported a loss of their sense of smell. The district court granted Matrixx’s motion to dismiss the case, for failure to state a claim under the materiality or scienter (deceptive intent) requirements of the securities laws. The district court noted that the investors had alleged no data as to the reliability or accuracy of the user complaints, nor had they alleged that the complaints were statistically significant. The court cited Second Circuit decisions for the proposition that when shareholders seek damages for failure to disclose adverse event reports, materiality and scienter elements require, as a matter of law, allegations that the reports were statistically significant. See In re Carter-Wallace, Inc. Securities Litigation, 150 F.3d 153 (2d Cir. 1998); In re Carter-Wallace, Inc. Securities Litigation, 220 F.3d 36 (2d Cir. 2000) (both considering reports of aplastic anemia made in connection with the study or use of the anti-epilepsy drug Felbatol®). According to the Second Circuit, such a requirement ensures that the event may be caused by, rather than randomly associated with, the use of the drug.

The First and Third Circuits also have imposed statistical significance requirements in evaluating pleadings based on disclosure of adverse event reports. In New Jersey Carpenters Pension & Annuity Funds v. Biogen Idec Inc., 537 F.3d 35 (1st Cir. 2008), the First Circuit held that Biogen could not have intentionally misled investors about a risk that Tysabri® could cause opportunistic infections until the company knew there was something requiring disclosure, and that this knowledge could not arise from a few isolated reports without evidence of a causal relationship established through statistically significant findings. Id. at 44-53. Similarly, the Third Circuit held that American Home Products did not materially and intentionally mislead investors by failing to disclose all heart valve reports it had received about users of the diet drugs Pondimin® and Redux®, at a time when there was no statistically significant evidence establishing a serious health risk. Oran v. Stafford, 226 F.3d 275 (3d Cir. 2000).

Despite this authority, the Ninth Circuit Court of Appeals reversed the dismissal of claims in Matrixx Initiatives, stating that the district court’s reliance on the statistical significance standard was inconsistent with the Supreme Court’s rejection of bright-line rules related to materiality findings, and concluding that a “holistic” consideration of the complaint supported the necessary inferences that the information was withheld intentionally. Siracusano v. Matrixx Initiatives, Inc., 585 F.3d 1167 (9th Cir. 2009).

Matrixx filed a petition for Supreme Court review. The question presented was phrased as follows: “Whether a plaintiff can state a claim under § 10(b) of the Securities Exchange Act and SEC Rule 10b-5 based on a pharmaceutical company’s nondisclosure of adverse event reports even though the reports are not alleged to be statistically significant.” In support of its certiorari petition, Matrixx cited precedent from the First, Second and Third Circuits as being squarely opposed to the Ninth Circuit’s refusal to require statistical significance allegations. On June 14, 2010, the Supreme Court granted the petition.

Drug and medical technology companies already must navigate an extensive set of rules about when and how to disclose adverse event reports to government agencies and incorporate adverse event information into product labeling. Hundreds of thousands of adverse event reports are received each year by FDA, and many of these reports do not offer complete, reliable or accurate information. In this context, a bright line rule introducing certainty and clarity about when these reports must be shared with investors could prove very useful.

The shaping of a disclosure rule, however, will require careful consideration. The rule should not overstate the importance of a calculation establishing significance, such that plaintiffs could allege that any statistically significant finding automatically establishes or implies materiality and intent. In other words, statistical significance may be necessary, but should not be sufficient to plead violations of the securities laws. Further, if the statistical significance test is adopted, the necessary showing requires clarification and should carry an important and relevant scientific meaning. The Internet offers many computer programs that can generate risk numbers without good statistical or clinical reason. The FDA’s recent decision to make additional safety information available publicly also could prove to be a source of statistical data that may not be scientifically meaningful but could be used by plaintiffs. And, as has been shown in other contexts, plaintiff counsel may adapt quickly to new pleading requirements.

Matrixx Initiatives presents an important opportunity for the adoption of stricter pleading standards in shareholder lawsuits alleging failure to disclose adverse event reports. zThe Court recently has strengthened other pleading standards, in ways that have had meaningful effects on civil litigation. It remains to be seen whether and how the Court will strengthen pleading requirements in this case. Whatever the Court’s holding, its decision likely will have important implications for companies that receive and evaluate adverse event reports.

Source: www.faegre.com

WEST CHESTER, Ohio–(BUSINESS WIRE)–AtriCure, Inc. (Nasdaq: ATRC – News), a medical device company and a leader in cardiac surgical ablation systems, today announced that it received clearance from the FDA for its AtriClip Gillinov-Cosgrove Left Atrial Appendage Exclusion system. The AtriClip system is designed to safely and effectively exclude the left atrial appendage. Initial launch in the United States is anticipated to begin later this month with full commercial release planned during the third quarter of 2010.

“Clearance of the AtriClip system in the United States represents a major product and clinical milestone for AtriCure,” said David J. Drachman, President and Chief Executive Officer. “We believe that the AtriClip system provides a safe and efficient method to exclude the left atrial appendage. This key innovation represents a large and exciting new growth platform and demonstrates our steadfast commitment to developing market leading technologies to meet the needs of patients and physicians.”

About the Left Atrial Appendage and the AtriClip System

The AtriClip system includes a clip device that is designed to exclude the left atrial appendage, a hollow sac-like structure attached to the heart’s left atrium. The left atrial appendage has internal peaks and valleys, or trabeculations. During AF, stagnant blood pools in the trabeculations of the left atrial appendage and is known to form clots that can migrate to other parts of the body. The AtriClip is designed to be implanted from the outside of the heart, avoiding contact with circulating blood and eliminating blood flow between the left atrial appendage and the atria. The AtriClip system has been cleared by the FDA for occlusion of the left atrial appendage, under direct visualization, in conjunction with other open-heart cardiac procedures.

About AtriCure, Inc.

AtriCure, Inc. is a medical device company and a leader in developing, manufacturing and selling innovative cardiac surgical ablation systems designed to create precise lesions, or scars, in cardiac, or heart, tissue and systems for the exclusion of the left atrial appendage. Medical journals have described the adoption by leading cardiothoracic surgeons of the AtriCure Isolator® bipolar ablation system as a treatment alternative during open-heart surgical procedures to create lesions in cardiac tissue to block the abnormal electrical impulses that cause atrial fibrillation, or AF, a rapid, irregular quivering of the upper chambers of the heart. Additionally, medical journals and leading cardiothoracic surgeons have described the AtriCure Isolator system as a promising treatment alternative for patients who may be candidates for sole-therapy minimally invasive procedures. AF affects more than 5.5 million people worldwide and predisposes them to a five-fold increased risk of stroke. The FDA has cleared the AtriCure Isolator system and AtriCure’s multifunctional pen and CoolrailTM linear ablation device, for the ablation, or destruction, of cardiac tissue during surgical procedures. Additionally, the FDA has cleared AtriCure’s multifunctional pen for temporary pacing, sensing, stimulating and recording during the evaluation of cardiac arrhythmias and AtriCure’s Cryo1 system for the cryosurgical treatment of cardiac arrhythmias. To date, the FDA has not cleared or approved AtriCure’s products for the treatment of AF.

Boston Scientific Corporation (NYSE: BSX) announced the market launch and first implants of its TAXUS® Element™ Paclitaxel-Eluting Coronary Stent System in the European Union and other CE Mark countries. The TAXUS Element Stent System is the Company’s third-generation drug-eluting stent (DES) technology and incorporates a platinum chromium alloy with an innovative stent design and an advanced catheter delivery system. It received CE Mark approval last month, which included a specific indication for the treatment of diabetic patients.

The first European implants were performed by Corrado Tamburino, M.D., Ph.D., Chair of the Cardiology Department at Ferrarotto Hospital, Catania, Italy and Adrian Banning, M.D., Directorate Chair of Cardiac Services at John Radcliffe Hospital, Oxford, U.K.

“I have found the TAXUS Element Stent to offer performance advantages in flexibility, visibility and deliverability over prior-generation stents,” said Dr. Tamburino. “The platinum chromium alloy and new stent design used in the Element platform, together with the proven TAXUS drug and polymer, represent a significant advance in coronary stenting.”

“The diabetic indication for the TAXUS Element Stent System provides an important benefit given that approximately one third of all patients presenting with coronary artery disease in Europe have diabetes,” said Dr. Banning. “Diabetic patients with coronary artery disease often have poorer outcomes after revascularization procedures. The paclitaxel-based TAXUS Element Stent has a unique mechanism of action that helps inhibit restenosis in high-risk patients with diabetes.”

The TAXUS Element Stent is designed specifically for coronary stenting and leverages the performance advantages of the Element Stent platform with a decade of clinical success from the TAXUS program. The novel stent architecture and proprietary platinum chromium alloy combine to offer greater radial strength and flexibility. The stent architecture helps create consistent lesion coverage and drug distribution while improving deliverability, which is enhanced by an advanced catheter delivery system. The higher density alloy provides superior visibility and reduced recoil while permitting thinner struts compared to prior-generation stents(1).

In March, the Company announced 12-month results from its PERSEUS clinical program demonstrating positive safety and efficacy outcomes in workhorse lesions for the TAXUS Element Stent System compared to the TAXUS® Express2® Stent System. Those results were recently published in the Journal of the American College of Cardiology. The PERSEUS results also reported a similar safety profile and statistically superior efficacy outcomes in small vessels for the TAXUS Element Stent compared to a historical control group of patients receiving the Express® bare-metal Stent.

The Company received CE Mark approval for the PROMUS® Element™ Everolimus-Eluting Stent System in October 2009. Both Element Stent Systems incorporate the same platinum chromium alloy, innovative stent design and advanced catheter delivery system.

In the U.S., the Company expects Food and Drug Administration approval for the TAXUS Element Stent System in mid 2011 and for the PROMUS Element Stent System in mid 2012. In Japan, the Company expects approval for the TAXUS Element Stent System in late 2011 or early 2012 and for the PROMUS Element Stent System in mid 2012.

In the U.S. and Japan, the TAXUS Element Stent and the PROMUS Element Stent are investigational devices and are limited by applicable law to investigational use only and are not available for sale.

(1) Based on bench testing. Data on file with Boston Scientific.

Source
Boston Scientific

At the 2010 annual meeting of the Society for Imaging Informatics in Medicine (SIIM), GE Healthcare is delivering today’s innovations and engaging in tomorrow’s trends. The company’s technology exhibition spanning the Centricity Imaging portfolio includes everything from truly integrated RIS/PACS, to automated diagnostic reporting, to a peek at the next big things to leap from their sketchpads into our world.

Visionary solutions, today

GE Healthcare is committed to solutions that unify imaging IT – integrating multiple applications via an open, web-based approach; aggregating clinical information to a single patient view; and connecting local and remote imaging workflow seamlessly to all clinical stakeholders. This bold vision of “One desktop, One patient, One community” is the driving force behind the products and services presently offered and being developed by GE Healthcare. Central to this vision is the well-documented growth projection, and continuous improvement focus of data-aggregating, timesaving dashboards. “Decide to Thrive: Operational Dashboards Key to Radiology in an Era of Healthcare Reform” is GE Healthcare IT SVP and Global GM Don Woodlock’s look at where the market is heading and how operational dashboards could help.

“What we did was explore what the market has now and project how healthcare reform will impact both the products and the players,” said Woodlock. “Then we spoke with some key thought leaders about where they see things heading and they all concluded the same thing. Operational dashboards will shape the future of the field.” GE is showcasing its work-in-progress contribution in its booth this week.

Organizations already using such tools point to a broad range of benefits. Trident Medical Center in Charleston, S.C. is a part of the HCA Inc. network and is testing a suite of tools designed by GE Healthcare. Director of Imaging Jodi Barteet and staff use a real-time dashboard to monitor imaging procedures and proactively prevent delays. A large-screen monitor shows the status of each pending exam against a target turnaround time.

“We have it color-coded, so that the patient indicators turn a different color when they get close to that turnaround time,” said Barteet. “If they’ve been waiting 30 minutes, they turn yellow. If they’ve been waiting 45 minutes, they turn red. So at any given time, our staff can see at a glance when each procedure was ordered and how long it’s taking for the exam to be done, and act accordingly.”

“You want to be able to take the pulse of your organization,” observed James Whitfill, Chief Information Officer at Scottsdale (Ariz.) Medical Imaging. “You don’t want to wait for the next quarterly report to come out and say, ‘Oh, no – we have a problem!’ You want to know about issues in a timely manner so that you can be more nimble.”

Integration Made Easy

With the ever-changing demands and dynamics of outpatient imaging, GE Healthcare has focused attention on the specific needs of outpatient imaging centers. Imaging Centers are unique businesses that operate in very competitive environments and require IT systems that can help streamline operations, improve customer service and drive revenue. They require a completely integrated revenue cycle management/RIS/PACS solution specifically designed for their needs. The Centricity RIS/PACS-IW Solution delivers a full-featured, web-based enterprise application that serves the specific needs of the outpatient imaging center. It provides each organization the ability to complete the patient care cycle in a more streamlined, reproducible manner that makes collections and billing not an adjunct, but a central part of the process.

Reporting with Precision

GE is also showcasing the strengths of its diagnostic reporting solution that leverages advanced speech understanding across its RIS and PACS portfolios. Woodlock will speak to Centricity Precision Reporting’s features and its future in relation to current market trends, in a SIIM-sanctioned learning track and vendor tie-in session (Learning Track #5 – Automated Reporting Systems- Friday, June 4, 3:30-5pm). The evolutionary solution weds efficient workflow with a sophisticated speech-understanding engine to capture patient data throughout the radiology reporting and image archiving processes.

Symbiosis Supplied

For GE Healthcare IT and its imaging customers, the conference week began Tuesday with the convening of the GE Healthcare Centricity Imaging User Summit. The day featured best-practice-sharing opportunities, roundtable discussions with GE leadership and product teams in addition to educational sessions all aimed at helping attendees make an immediate impact on improving workflow and productivity within their organizations. Three breakout user groups met on Wednesday to round out the latest demonstration of GE’s unparalleled customer commitment.

“At SIIM, we have a unique opportunity to gain from and to give to our customer base while truly showcasing the strengths of our business,” said Woodlock. “We look forward to a week of thorough engagement and plan to demonstrate how we’ll continue delivering on the promise of ‘One desktop, One patient, One community’ for all.”

Source
GE Healthcare

Johnson & Johnson will be reviewing the growth strategies for its Medical Devices & Diagnostics (MD&D) segment at a meeting with the investment community today. Senior leaders will be highlighting the new products, robust pipelines, expanding geographic presence, and other strategies that will sustain the long-term growth of the company’s largest business segment in a $350 billion, worldwide medical device and diagnostics market.

“Thanks to the hard work of thousands of talented associates, we are the largest and strongest medical device company in the world today, and poised to continue advancing patient care in the future,” said Alex Gorsky, worldwide chairman of Johnson & Johnson’s Medical Devices & Diagnostics segment.

The company’s MD&D business segment, which generated $23.6 billion in sales in 2009 and became Johnson & Johnson’s largest business segment, holds the No. 1 or 2 market positions in the majority of its markets. It includes seven global franchises:

- Cordis: a leader in the treatment of cardiovascular disease;
- DePuy: a leader in orthopaedics, spinal care, sports medicine and neurosurgical devices;
- Diabetes Care: a leader in products that allow people with diabetes to monitor and control their blood glucose levels;
- Ethicon: a leader in sutures, tissue repair and reinforcement products, women’s health, aesthetics and conditions of the ear, nose and throat;
- Ethicon Endo-Surgery: a leader in surgical device solutions for minimally invasive and open surgery; and Advanced Sterilization Products, a leading developer of solutions for the reduction of healthcare-associated infections;
- Ortho Clinical Diagnostics: a leader in medical diagnostic products;
- Vision Care: a leader in the global contact lens market.

“Our MD&D businesses compete in a number of large, well-established and under-penetrated markets like joint replacement, contact lenses and sutures — markets where we can grow through the introduction of more advanced products and continued geographic expansion,” said Gorsky. “At the same time, we are expanding into other high-growth markets such as biosurgicals, energy, electrophysiology and other surgical specialties. We are using our own pipeline, as well as licensing agreements and select acquisitions, to bring us new capabilities.”

Launching New Products

Today’s presentations will highlight a number of products that have either launched this year or are continuing their global roll-outs in 2010.

Ethicon Endo-Surgery, for example, continues to introduce new energy instruments as part of its HARMONIC® family of technology that delivers precise ultrasonic energy to minimize thermal tissue damage to the patient, while providing surgical efficiency. Diabetes Care is rolling out a new blood glucose monitoring system, OneTouch® Verio ™ that provides the next generation of accuracy and precision, the number one need for diabetes patients. Meanwhile, Vision Care continues rolling out its 1-DAY ACUVUE® TruEye™ Brand Contact Lenses, the world’s first daily disposable silicone hydrogel lens on the market, which is currently available in Europe and Japan and is expected to launch in the U.S. later this year.

Medtronic Inc., the world’s largest medical device maker, spent about $1.07 million lobbying Congress in the first quarter, according to a recent disclosure form.

The company lobbied on parts of the health care overhaul passed into law in March that call on medical device makers to pay between $2 billion and $3 billion in fees per year to fund expanding health care coverage. While industry executives have complained about the fees, Democratic lawmakers say device companies will benefit from health care reform as more patients will become insured and therefore eligible to get their products.

The company also lobbied on efforts in Congress to make it easier for patients to sue medical device companies via personal injury lawsuits.

Medical device companies are largely shielded from patient lawsuits at the state level by a Supreme Court decision that gave federal regulators the final say in declaring a device safe or unsafe. Democrats, backed by trial lawyers and patient groups, want to overturn that decision, which they say misinterprets the law.

Medtronic lobbyists also advocated their position on a bill aimed at updating the U.S. patent system. The pharmaceutical and medical device industries have argued that reform efforts must not weaken patent protections on medical products by reducing infringement penalties. The reform effort has largely stalled in Congress.

Medtronic also lobbied on legislation that would increase the regulation of medical devices manufactured in foreign countries by charging additional user fees for FDA inspections, according to a form filed April 20 with the House clerk’s office.

Source: Business Week

Abbott (NYSE: ABT) today announced positive six-month results from the first 45 patients enrolled in the second stage of the ABSORB trial, which was presented during the Late-Breaking Clinical Trials session at the EuroPCR 2010 conference. At six months, Abbott’s bioresorbable vascular scaffold (BVS) demonstrated strong results, with a low (4.4 percent) rate of major adverse cardiac events (MACE1) and no blood clots (thromboses). Abbott’s BVS also demonstrated an in-stent late loss rate of 0.19 mm. Late loss is a measure of vessel re-narrowing and looks at the change in the diameter inside the device between the time immediately following scaffold placement and at six months. The amount of re-narrowing tells physicians how effective a scaffold procedure was at keeping the blood vessel open.

“With each new data milestone, Abbott’s revolutionary BVS technology is one step closer to becoming a reality. The device achieved a six-month late loss rate of 0.19 mm. This finding suggests that the BVS may have the potential to treat a blocked vessel as effectively as a metallic drug eluting stent, with the added potential benefit of not leaving a permanent implant behind after the vessel is healed,”said Patrick W. Serruys, M.D., Ph.D., professor of interventional cardiology at the Thoraxcentre, Erasmus University Hospital, Rotterdam, the Netherlands, and principal investigator for the ABSORB trial. “These extraordinary findings signal that Abbott’s disappearing scaffold may become the new standard of care for treating coronary artery disease.”

Abbott’s BVS, which is under clinical investigation in Europe, Australia and New Zealand and is not currently available for sale anywhere in the world, is made of polylactide, a proven biocompatible material that is commonly used in medical implants such as dissolving sutures. The bioresorbable technology is designed to restore blood flow by opening a clogged vessel and providing support until it is healed. Once the vessel can remain open without the extra support, the bioresorbable scaffold is designed to be slowly metabolized and eventually resorbed by the body. Since a permanent implant is not left behind, a vessel treated with a BVS ultimately may have the ability to move, flex and pulsate similar to an untreated vessel. The potential to restore these naturally occurring vessel functions, or vascular restoration, is one of the features that will make Abbott’s BVS unique in the treatment of coronary artery disease.

“In addition to achieving low late loss, Abbott’s bioresorbable scaffold demonstrated positive clinical outcomes, with no thrombosis and a low rate of adverse events at six months. These results are encouraging and add to the strong body of BVS data that has been gathered over the last several years,” said Charles A. Simonton, M.D., FACC, FSCAI, divisional vice president, Medical Affairs, and chief medical officer, Abbott Vascular. “The ABSORB trial is a perfect example of Abbott’s dedication to developing technology that has the potential to revolutionize the way physicians treat coronary artery disease.”

About the ABSORB Clinical Trial

The ABSORB trial is a prospective, non-randomized (open label), two-phase study that enrolled 131 patients from Australia, Belgium, Denmark, France, the Netherlands, New Zealand, Poland and Switzerland. Key endpoints of the study include assessments of safety – MACE and treated site thrombosis rates – at 30 days; six, nine, 12 and 24 months; with additional annual clinical follow-up for up to five years, as well as an assessment of the acute performance of the bioresorbable vascular scaffold, including successful deployment of the system. Other key endpoints of the study include imaging assessments by angiography, intravascular ultrasound (IVUS), optical coherence tomography (OCT), and other state-of-the-art invasive and non-invasive imaging modalities at six, 12, 18 and 24 months. The next 56 patients in the second phase of the ABSORB trial will undergo imaging follow-up one year after their procedures, and all 101 patients in the second phase of the trial will receive follow-up imaging at two years.

Abbott’s bioresorbable technology delivers everolimus, an anti-proliferative drug. Everolimus is developed by Novartis Pharma AG and is licensed to Abbott by Novartis for use on its drug eluting vascular devices. Everolimus has been shown to inhibit treated site neointimal growth in the coronary vessels following vascular device implantation, due to its anti-proliferative properties.

About Abbott Vascular

Abbott Vascular is a global leader in cardiac and vascular care with market-leading products and an industry-leading pipeline. Abbott Vascular offers a comprehensive cardiac and vascular devices portfolio, including products for coronary artery disease, vessel closure, endovascular disease, and structural heart disease.

1 MACE is a composite measure of key efficacy and safety endpoints and includes cardiac death, heart attack (myocardial infarction) and ischemia-driven target lesion revascularization.

Source
Abbott

LensAR, Inc., the leading developer of next generation laser technology for cataract surgery and presbyopia, announced that the company has received 510(k) clearance from the FDA for use of the LensAR Laser System for anterior capsulotomy during cataract surgery.

The LensAR Laser System integrates propriety ocular measurement and 3D laser scanning technologies with an advanced tissue cutting laser. The clinical data from the APEC Hospital Mexico City showed the laser capsulotomies were significantly more precise than manual capsulorhexis in the intended vs. achieved diameter and in circularity.

“The capsulotomy is arguably the most critical and precise step in cataract surgery and the ability to improve its sizing, centration, and consistency through automation is an important and exciting advance,” stated Dr. David F. Chang, LensAR Medical Monitor, who has personally used the LensAR Laser System in Mexico.

Dr. Louis D. “Skip” Nichamin, Medical Advisory Board member, who also has had experience using the system directly, commented, “The application of femtosecond technology to cataract surgery is the most exciting development in ophthalmic surgery in decades. The increased precision of the LensAR technology can help in the improvement of surgical outcomes while assisting experienced and inexperienced surgeons achieve more consistent results.”

“This is a critical milestone for the company. Our first cleared indication of what we believe will be many to come in this exciting new field of laser cataract surgery,” said Randy Frey, founder and chief executive officer of LensAR.

About LensAR, Inc.

LensAR, Inc. is the leading developer of next generation laser technology for cataract surgery and presbyopia. The LensAR Laser System, which integrates an advanced ultra short pulse laser with propriety ocular measurement and laser scanning technologies, is being designed to allow physicians to perform several of the steps in cataract surgery (capsulotomy, lens fragmentation, precise astigmatic corrections and unique clear corneal incisions) in a single laser procedure. In addition to advancing its laser technology in the area of cataract surgery, the company is also developing the LensAR Laser System for the treatment of presbyopia.

The LensAR Laser System is cleared by the FDA for anterior capsulotomy. For other indications it is an investigational device limited by United States law to investigational use only.

Source: LensAR, Inc