ZOLL Medical Corporation (NasdaqGS: ZOLL), a manufacturer of medical devices and related software solutions, announced that it has received 510(k) clearance from the U.S. Food and Drug Administration to market and begin distribution of the new Propaq® M Monitor, a vital signs monitor for deployable military medicine that was developed to meet the special needs of military customers and air medical operations worldwide. Development of this product was a joint undertaking between the Department of Defense and a cooperative arrangement between Welch Allyn and ZOLL. Development was facilitated with grants from the U.S. Army Medical Research and Development Command.

The Propaq M is a new ultra-lightweight, compact device that combines highly sophisticated, advanced capabilities with the well-accepted and proven features of the Propaq monitors. New features of the Propaq M include 12-lead monitoring, a third invasive pressure channel, extensive trending and data collection, a large high-contrast color display with 4-waveform capability, a night vision goggle (NVG) mode for military and air medical night operations, and a user-removeable battery that will operate all the physiological parameters for over 7.5 hours. These new capabilities were designed into a new small, lightweight, rugged package nearly 5 lbs. lighter than currently deployed technology.

The Propaq M is a companion monitor version of the recently FDA-cleared Propaq MD transport monitor/defibrillator and has been developed to have a completely identical and common interface for operation, batteries, power supplies, blood pressure cuffs, cables, accessories, and data. This common interface between the Propaq M and Propaq MD facilitates a seamless transition and operator readiness. The Propaq M is the first transport monitor to utilize the same user interface and components as the Propaq MD, thus allowing military and air medical services to save significant expenses in training and logistics. These new products comprise the first system designed with a combination of interchangeability, flexibility, and portability to meet the special needs of critical care monitoring and therapy for the military.

“These two products, when combined, will meet the most expansive needs of the military for patient care in difficult environments,” said Jonathan A. Rennert, President of ZOLL. “The FDA clearance of both devices is a significant milestone for ZOLL. Given the success of earlier Welch Allyn Propaq monitors and ZOLL M Series® CCT (Critical Care Transport) monitor/defibrillators, we are well-positioned to capture a significant share of the military market as the need to replace and upgrade devices creates substantial business opportunities.”

In addition to the common interfaces between the Propaq M and Propaq MD, virtually all existing Propaq 206 monitor accessories, cables connectors, and ZOLL M Series CCT defibrillation accessories currently used in military applications will be compatible with the new products.

Designed specifically for the tough demands of battlefield medicine, encompassing air transport and evacuation, and highly mobile ground, sea and air deployments of medical assets, the Propaq M meets an unprecedented number of military and international standards related to durability, environmental operation and storage extremes, radio frequency emissions, and susceptibility to spurious electrical and radio frequency noise. The Propaq M, like Propaq MD, is rated to the most stringent water and sand/dust protection, achieving a rating of IP55, allowing protection from extremely fine sand and jets of water.

Source:
ZOLL Medical Corporation

Medtronic Inc.’s (NYSE:MDT) Integrity coronary stent received pre-market approval from the Food & Drug Administration and logged its first U.S. implantation.

The Fridley, Minn.-based medical device giant based the bare-metal stent on its so-called “continuous sinusoid technology,” which uses fewer welds than earlier stent models, such as the Driver, and a single wire of cobalt alloy.

The company designed the device to be more deliverable, or easier to insert. The stent’s first implantation, however, allowed it to exhibit its properties of comformability, according to Washington Adventist Hospital director of cardiac and vascular research Dr. Mark Turco, a Medtronic consultant, who performed the stent’s first implantation today.

Turco told MassDevice that the procedure involved a “bifurcation in the distal right corner artery” and while it didn’t significantly demonstrate the device’s deliverability, the operation “tested comformability in that it was an angulated right corner artery and that [the device] also allowed for good access into the side branch that was involved.”

Conformability is a measure of the stent’s ability to conform to the natural shape of the vessel, according to Medtronic.

The Integrity stent is “going to hopefully allow Medtronic to have another drug-elution vehicle for their drug-eluting stent program,” Turco said.

“It will be interesting to see whether this particular design helps with things like side-branch access and in treating bifurcation lesions,” he added.

Medtronic won CE mark approval for the Integrity stent system in February and the device is available in approximately 100 countries outside the U.S. The company said the stent enabled the it to lead the bare-metal stent market in Western Europe and Central Asia.

A company spokeswoman said continuous sinusoid technology will serve as the foundation for Medtronic’s pipeline going forward. Medtronic announced the FDA approval and implantation today ahead of the 2010 Transcatheter Cardiovascular Therapeutics conference in Washington, D.C.

ReNu Medical, Inc., an environmentally safe and sustainable medical device reprocessor, announces that in August 2010, FDA completed a full Quality Systems inspection without noting any observations or deficiencies. This is the fifth consecutive inspection that ReNu Medical has demonstrated full compliance with the federal regulations for quality in medical device manufacturing and reprocessing.

“This impressive record of continuing full compliance with the federal Quality Systems Regulation demonstrates the commitment this company has to providing its customers with safe, effective reprocessed medical devices,” said Don Selvey, international-recognized expert in medical device reprocessing and ReNu Medical Board Director. “ReNu Medical continues to work diligently to reprocess non-sterile medical devices according to best practices, and to exceed customer expectations for quality medical devices.”

Since the inception of the company in 2000, ReNu Medical has been inspected by the FDA on a regular basis, in accordance with the federal laws for medical device manufacturers. Consistently, the FDA inspectors find the company to be in full compliance with all requirements.

When a deficiency is found in an inspection, FDA provides formal notice of violation and requires the company to provide a written plan to correct problems. If a company fails to correct the violation, FDA may seek sanctions against the company, up to an including civil and criminal charges. Companies with serious violations can be found through public records on the FDA website, located here.

“Consistently receiving Establishment Inspection Report’s (EIR) with zero deficiencies from the FDA, is the best assurance we can give our hospital customers and their patients, that ReNu Medical provides the safest, highest quality reprocessed products possible in the industry,” said Randy Long, ReNu Medical CEO.

ReNu recommends to hospitals that as part of any current contract review, or prior to executing a new contract with a medical device manufacturer or reprocessing company, they review the history of Warning Letters and Establishment Inspection Reports (EIR) from each company. These reports provide a clear indication to hospital purchasing agents and quality assurance authorities how that company values quality in their products.

“We follow the strictest safety protocols,” said Bruce Pierson, ReNu Medical COO. “It’s very gratifying to have the FDA recognize our proprietary methodology and protocols meet their high standards for reprocessed medical devices. Our trained professionals ensure that full regulatory compliance is employed in every step of the process delivering a 100% non-toxic, safe, quality alternative to healthcare facilities nationwide.”

ReNu continues its long standing focus on patient safety and cost savings while maintaining the highest levels of compliance with FDA guidelines and standards.

Source:
ReNu Medical

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.

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

Optovue, a pioneer in fourier/spectral-domain optical coherence tomography (OCT), has announced that the new iVue compact SD-OCT has received FDA 510(k) clearance on April 29, 2010.

“The iVue compact SD-OCT was officially launched outside the United States in January of this year, and we have seen very high demand – as expected – in the first quarter,” stated Paul Kealey, Vice President of Marketing for Optovue. “This regulatory clearance for the US market allows us to offer the benefits of advanced OCT imaging to more segments within eye care, where the economic feasibility of the larger systems simply did not work. The iVue begins the next phase of the OCT revolution in the US that started with the RTVue launch in 2006.”

The iVue compact SD-OCT system is delivered on a standard slit lamp style base and is comprised of a small scanning head (4.5 lbs / 2.2 kg), a control module, laptop PC and foot switch. The system can be mounted to a small table and may have other mounting options in the near future for other eye care environments.

About RTVue and iVue

RTVue was the first FDA cleared Fourier domain (also known as spectral domain) OCT launched in the United States, and also the first OCT cleared by the U.S. Food and Drug Administration for both corneal and retinal imaging. The iVue is the compact fourier-domain version of the RTVue OCT, offering the same scanning speed and resolution as the larger system, that includes scanning and reports for retina, retina nerve fiber and cornea assessment by the clinician.

About Optovue

Optovue Incorporated is a privately-held ophthalmic device company dedicated to working with eye care professionals and clinical researchers to lead the commercialization of new imaging modalities that improve diagnosis and therapy of ocular disease. Optovue has achieved widespread market success through a combination of unique data analysis design, a reputation for excellent customer service, and rapid innovation of its technology in response to physician feedback. The company is headquartered in Fremont, CA, with operations in Carlsbad, CA and European operations in Heidelberg, Germany.

Source: Optovue

Embrella Cardiovascular™, Inc., a medical device company, announced its European notified body has granted CE Mark approval for the company’s Embrella Embolic Deflector®, an aortic embolic protection device which acts as a protective shield to reduce the incidence of embolization to the brain. This approval will allow the Company to begin marketing the device in European countries and other countries around the world that recognize the CE Mark approval process.

The Embrella Embolic Deflector® will serve as an adjunctive device to be used in procedures such as the less invasive Transcatheter Aortic Valve Implantation (TAVI) procedure. This technology is currently approved in Europe for high risk patients with severe aortic stenosis. Frequently the aorta contains atheromatous plaque and the valve can be densely calcified. During TAVI, wires, catheters and balloons pass over the aortic arch where they may dislodge debris and calcific particles. Unless deflected from the arteries leading to the head, such debris may embolize to the brain and cause stroke.

Commenting on this CE Mark approval, Embrella Chairman and CEO, Jeffrey O’Donnell said, “The TAVI market is expected to grow dramatically over the next few years. According to analysts, the global TAVI market is expected to grow from over $200 million in TAVI sales in 2009 to over $1.7 billion in 2015. This approval enables us to begin to commercialize the Embrella Embolic Deflector® in European markets. We believe that cerebral protection will be used as a standard of care in all Transcatheter Aortic Valve Implantation procedures.”

“We are pleased that we continue to receive positive feedback from physicians in Europe and Canada. They not only find the Embrella Embolic Deflector® to be intuitive and easy to use, but it also performs effectively without affecting the index procedure,” added Carol Burns, Vice President, Product and Business Development.

Source
Embrella Cardiovascular