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

BIOTRONIK announced that the U.S. Food and Drug Administration has cleared the Evia® pacemaker for distribution in the U.S., giving physicians and patients access to a unique Bradycardia system designed and manufactured with BIOTRONIK’s unparalleled legacy of quality.

Evia® is the only device that provides a decade of longevity and innovative therapies for physiologic pacing packaged into a device that is 20 percent smaller than our current can size and which has integrated wireless remote monitoring. BIOTRONIK is a leading manufacturer of high-quality implantable cardiac devices and the pioneer of wireless remote monitoring technologies.

Setting the Standard for Remote Monitoring

Evia provides advanced patient management with the complete integration of the clinically proven1 BIOTRONIK Home Monitoring® system. BIOTRONIK introduced home monitoring to the industry almost a decade ago with a system that today monitors, stores data, and provides physicians with early alerts that save lives and prevent hospitalizations. Evia has the unique capability to cellularly transmit required patient and device data, including IEGM Online HD, to perform a complete remote follow-up. It is the world’s smallest pacemaker with integrated wireless remote monitoring. This technology is fully compliant with Heart Rhythm Society and European Heart Rhythm Association device follow-up specifications. Last year, the FDA approved BIOTRONIK Home Monitoring® as the only remote monitoring system on the market that can replace conventional device interrogation during follow-ups.

Quality in every step of the production process

“BIOTRONIK looks forward to providing physicians with the important advancements Evia will bring to their practices. Evia is the latest example of BIOTRONIK’s absolute commitment to deliver quality products designed to enhance patients’ lives,” commented Jake Langer, president, BIOTRONIK U.S.

Evia is the first pacemaker in which all electronic components have been manufactured and tested with full automation, eliminating human touch and minimizing room for human error.

“BIOTRONIK is committed to developing and delivering products like Evia, because quality of life is paramount for patients,” Langer added.

Longevity – A new standard

The REPLACE Registry, sponsored by BIOTRONIK, is a multi-center analysis that quantified complication rates in device replacement procedures utilizing devices from all CRM industry manufacturers. The registry showed that one in 10 patients will suffer side effects and complications from device replacement. “By providing a decade of longevity with Evia, BIOTRONIK again has demonstrated its focus on patient-centric innovations,” stated Langer. “Evia’s new design provides a dramatic reduction in energy consumption. Replacement is safe for most patients, but we have minimized that small risk to a new standard.”

Small Device Delivers Wide Array of Therapy

Evia includes BIOTRONIK’s proprietary and proven Closed Loop Stimulation (CLS), which is the most advanced and physiologic rate regulation algorithm available on the market. CLS integrates into the natural cardiovascular loop by measuring changes in myocardial contraction dynamics and translating them into appropriate heart rate regulation, emulating a healthy sinus node, the human heart’s natural pacemaker. CLS is also the only rate regulation algorithm that is proven to pace effectively during periods of acute mental stress. Intrinsic Optimization (I-Opt), a one-button programming solution, optimizes AV delay with AV hysteresis (up to 400 ms) to minimize right ventricular pacing.

1. Varma N. et al. Evaluation of efficacy and safety of remote monitoring for ICD follow-up: the TRUST trial (abstract 4078). Circulation. 2008; 118;2316.

Source
BIOTRONIK

Five engineering breakthroughs, from software for virtual surgery to an energy saving device that detects drafts, were cited today by IEEE-USA, the U.S. career and public policy unit of the IEEE, the world’s largest professional association for the advancement of technology.

The five breakthroughs, as included in television news reports recently distributed to almost 200 local U.S. TV stations, are:

1. “Doctors Playing Doctor,” in which biomedical engineers designed software that allows surgeons to perform a virtual surgery before entering the operating room
2. “Save Money: Cut Energy Costs,” in which engineers have designed a hand-held device that detects drafts around windows and doors
3. “Soldier Safety: Sniper-Detecting Helmet,” in which electrical engineers (EEs) have developed a system that allows a soldier’s combat helmet to determine the locations of enemy shooters and the type of weapons they are firing
4. “Can You Hear Me Now?,” in which EEs have designed a radio chip for communication devices that mimics the way the human ear absorbs sound
5. “‘Intelligent’ Tools Help Disabled,” in which artificial intelligence researchers have developed intelligent medical assistive devices that make mobility easier for patients

Source:
Pender M. McCarter

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

Covidien (NYSE: COV), a leading global provider of healthcare products and recognized innovator in mechanical ventilation, announced 510(k) clearance from the U.S. Food and Drug Administration (FDA) to expand the Puritan Bennett™ 840 ventilator’s minimum delivered tidal volume down to 2 mL. This feature will enable the Puritan Bennett 840 ventilator to provide ventilatory support for neonates weighing as little as 300 grams.

The Puritan Bennett 840 ventilator delivers a comprehensive, user-friendly solution offering ventilation for a broad range of patients and acuity levels, from neonates to adults. Multiple therapies of ventilation help clinicians respond with the most appropriate ventilation strategy, including a neonatal continuous positive airway pressure (CPAP) mode, enabling noninvasive ventilation in neonates.

The ability to deliver a minimum tidal volume of 2mL will enable clinicians to safely ventilate the smallest and most critically ill neonatal patients with the Puritan Bennett 840 ventilator. This feature will complement recent enhancements to the Puritan Bennett™ 840 NeoMode™ software, including neonatal CPAP mode and the ability to increase the fraction of inspired oxygen (FiO2) by 20% for up to two minutes during suctioning. An increased FiO2 is necessary to manage adequate oxygenation in patients who are critically ill.

“This FDA 510(k) clearance allows Covidien to make clinicians aware that one device, the Puritan Bennett 840 ventilator, can be used on all patients from newborn to adults,” said Douglas Hansell, M.D., M.P.H., Chief Medical Officer and Vice President, Respiratory and Monitoring Solutions, Covidien. “Now patients, from the smallest neonates in the NICU through adults in the ICU, can receive the clinical benefits provided by the Puritan Bennett 840 ventilator.”

Source
Covidien