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.

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

Terumo Medical Corporation, a U.S.-based subsidiary of Terumo Corporation, has announced it has received an investigational device exemption (IDE) conditional approval from the U.S. Food & Drug Administration (FDA) for its Occlusive/Stenotic Peripheral Artery Revascularization Study (OSPREY) in the U.S., which will evaluate the safety and effectiveness of the MISAGO™ Self-expanding Stent System for use in the superficial femoral artery (SFA). This marks the company’s first U.S. clinical trial for a premarket approval (PMA) device. A unique feature of the clinical trial is that it will simultaneously enroll patients in the U.S. and Japan. Referred to as “Medical Device Collaborative Consultation and Review of Premarketing Applications” under the larger “Harmonization by Doing” (HBD) initiative, Terumo’s trial was selected as one of two projects to pilot this approach, which is intended to shorten the gap between product approvals in these two significant world healthcare markets.

HBD is an international effort to develop global clinical trials and address regulatory barriers that may be impediments to timely device approvals. This process is a cooperative effort to move both Japan and the U.S. toward international regulatory harmonization. The HBD initiative is a pilot project launched in December 2003 that seeks regulatory convergence between FDA and MHLW-PMDA (Japan’s regulatory bodies). The learning obtained in the “proof of concept” trials will assist both regulatory bodies in streamlining the clinical trial process for faster approvals in both countries, as well as promote the idea of global trials for purposes of collecting better data. In this pilot HBD approach, the products will be submitted for review and approval at the same time.

“I believe this approach to shorten the time for new product approvals between the U.S. and Japan is critical and exciting,” said Takao Ohki, MD, Chairman and Professor, Department of Surgery, Jikei University School of Medicine, Division of Vascular Surgery, and the global principal investigator of the OSPREY trial. “This innovative movement could dramatically solve the current device lag issue between our countries.”

In the U.S., OSPREY is a single-arm, multi-center, non-randomized prospective clinical trial for the treatment of atherosclerotic stenoses and occlusions of the SFA. In Japan, there are two arms of the study, 50 patients receiving the MISAGO Stent and 50 patients receiving percutaneous transluminal angioplasty (PTA).

The primary endpoints of the U.S. study are:

• Primary stent patency rate at one year as confirmed by duplex ultrasound or angiography.
• Freedom from major adverse events within 30 days of the procedure, which would result in target lesion revascularization, amputation of the treated limb or death.

The study will include up to 350 patients, a maximum of 250 patients in up to 30 centers in the U.S. and 100 patients in Japan. There have already been six patients enrolled in Japan, which received regulatory approval to begin the trial last year. The first U.S. enrollments are expected in June 2010. The U.S. principal investigator is J. Fritz Angle, MD, Associate Professor of Radiology, University of Virginia.

“Peripheral vascular disease management continues to be a major clinical problem,” said Dr. Angle. “We need better tools to improve revascularization of femoral-popliteal vessels. I applaud Terumo’s efforts to advance this field.”

The MISAGO Self-expanding Stent consists of a nitinol stent pre-mounted on the distal portion of a rapid-exchange delivery catheter system. The stent has three radiopaque markers located on each end of the stent to help ensure accurate placement in the lesion. The stent is currently available for sale in Europe.

“We are eager to move forward with the first harmonized clinical trial in the U.S. and Japan,” said Juichi (Jim) Takeuchi, President and CEO, Terumo Medical Corporation. “We are not only proud of the MISAGO Stent, but also of Terumo’s selection to participate in this precedent-setting international collaborative effort between regulators, industry, clinical researchers, patients, and academia. We look forward to initiating our first PMA clinical trial in the United States and to bringing innovative new interventional technology to market to improve patients’ quality of life.”

Source:
Robert Murphy
The Storch Murphy Group

Medtronic, Inc. (NYSE: MDT) announced today that it now offers the new Medtronic M-Link™ cellular accessory, which provides cardiac device patients with an option to securely send information stored in their implanted devices to their clinics via the CareLink® Network using cellular signals, rather than a telephone landline. This simplified connection to the CareLink® Network enables clinicians to remotely monitor more patients who are implanted with cardiac devices.

“The M-Link cellular accessory is making remote monitoring accessible to a greater number of eligible patients,” said Pat Mackin, president of the Cardiac Rhythm Disease Management business and senior vice president at Medtronic. “Now patients without a telephone landline have a convenient option to access the CareLink Network and take advantage of the benefits that come with remote monitoring, including fewer in-clinic visits and peace of mind from knowing their device data can be transmitted using cellular technology, without the need for a landline.”

The introduction of the M-Link cellular accessory comes on the heels of a landmark study showcasing the benefits of remote monitoring for patients and their physicians. Results from Medtronic’s CONNECT (Clinical Evaluation of Remote Notification to Reduce Time to Clinical Decision) trial presented at the American College of Cardiology Scientific Sessions in March 2010 showed cardiac resynchronization therapy-defibrillator (CRT-D) and implantable cardioverter-defibrillator (ICD) patients monitored through the CareLink Network experienced a significant reduction in time from clinical event to clinical decision and also benefitted from shorter hospital stays and reduced costs per hospitalization.

The M-Link cellular accessory provides patients with a convenient option to stay connected with their clinic from home, work, or while traveling globally. The M-Link cellular accessory securely connects to any CareLink Patient Monitor and allows patients to transmit data from their implanted device directly to their clinic through the secure CareLink Network. It also allows Medtronic CareAlert® Notifications to be transmitted when any of the programmable alert conditions from a patient’s implanted device has occurred. Physicians and nurses can view the transmitted data through a secure Web site, giving them the opportunity for a “real-time” look at how the patient’s device is functioning. The information transmitted is comparable to that provided during an in-clinic device follow-up visit.

Medtronic will showcase the M-Link cellular accessory as well as its portfolio of patient management and connectivity tools that simplify a clinician’s workday at Heart Rhythm 2010 in Denver, May 12-15, 2010 (booth 503). Also, showcasing the depth and breadth of data collected through Medtronic’s CareLink Network, four poster sessions and one late-breaking clinical trial will be presented at Heart Rhythm 2010 based on aggregate, de-identified data garnered exclusively through the CareLink Network.

About the Medtronic CareLink Network

The Medtronic CareLink Network is the world’s largest and most widely used remote monitoring system for implantable cardiac device patients, with more than 4,000 clinics and 500,000 patients enrolled in 30 countries. The CareLink Network has registered more than 2 million patient data transmissions since the service’s inception in 2002.

The CareLink Network provides the most flexible alert system in the industry that offers customizable and color-coded alert notifications for devices with Conexus® Wireless Telemetry. Through this network, patient data are transmitted from their implanted device using a portable monitor through cellular signals or a standard telephone line. Within minutes, the patient’s physician and nurses can view the data on a secure Internet Web site. Available information includes, but is not limited to, arrhythmia episode reports and stored electrograms along with device integrity information.

Source
Medtronic

The U.S. Food and Drug Administration today announced that it will change the way its expert panels review and discuss data and information during public hearings on medical devices under review for premarket approval, effective May 1, 2010.

The changes were prompted by an increasing number of medical device advisory panel meetings in recent years. In 2008, there were 10 panel meetings covering 14 major topics. In 2009, there were 17 meetings on 20 topics, and 2010 is on track to surpass those numbers, according to the FDA’s Center for Devices and Radiological Health (CDRH).

The increased activity has created challenges for CDRH and the way it operates panel meetings. In accord with current agency policy and guidance for advisory committees, the changes address staffing issues, voting procedures, and other items related to information presentation and flow of discussion.

“These changes are expected to empower the agency to make more effective decisions that are informed by more clear and focused discussion by panel experts,” said CDRH Director Jeffrey Shuren, M.D.

In the past, panel discussions have not always reflected a panel’s final vote on approvability. Now, instead of voting on the approvability of premarket approval applications, including conditions of approval, the panel will vote on the safety and effectiveness of a device and the device’s risk versus its benefit.

“By making this change in voting procedure, panel members will address key scientific issues during their discussions, which will be reflected in their votes,” Shuren said. “The change also will allow panel members to address issues related to their area of expertise instead of regulatory issues that may be unfamiliar to them.”

In addition, panels will vote by ballot instead of by a show of hands. While the votes will be publicly tallied so that panel members can be identified by their vote, the ballot process allows each panel member to cast his or her vote without immediate influence by other votes.

There are many issues involved in the FDA’s review of a medical device. Historically, the FDA’s presentations to panels included comments on approvability. With the changes, the FDA’s presentations will continue to include reviews of the agency’s data analysis, but will no longer include comments on approvability.

Before the changes, the agency medical device reviewers presented a unified, consensus analysis of supporting data. Now, reviewers will present together with data and analysis, the range of scientific opinion in the group. This move will allow more in-depth discussion on safety and effectiveness and risk versus benefit of the device under consideration..

The FDA and CDRH will continue to evaluate panel procedures and make changes when necessary. A detailed description of changes to panel operations can be found here.

For more information:

- FDA Advisory Committees: Medical Devices
- Medical Devices Advisory Committee

Source
U.S. Food and Drug Administration