Endologix Receives FDA Approval Letterfor the Powerlink
Endologix, Inc. announced the receipt of a Conditional Approval Letter from the U.S.
Food and Drug Administration (FDA), allowing the commercial distribution of the company's Powerlink® System, an endoluminal stent graft (ELG) for the minimally invasive treatment of abdominal aortic aneurysms (AAA). The conditions of approval require the standard continued post-marketing surveillance and annual update reports to the FDA and physician users.
According to the Society of Interventional Radiology, AAA is the 13th leading cause of death in the U.S., claiming 15,000 lives each year. U.S. Conditional marketing approval for the Powerlink System was granted based on FDA review of the pre-market approval (PMA) application Endologix filed in January 2004. This marked the final step in a modular submission process that included results of Endologix's pivotal clinical trial with the Powerlink System.
The pivotal trial included 192 test patients and 66 controls treated by conventional open surgery. Trial highlights include:
• Powerlink System was successfully deployed in 97.9% of test patients.
• The study demonstrated a significantly lower mortality rate for the Powerlink patients versus open surgery during the 30-day post operative period, 1.04% versus 6.06%. This was in spite of the mean age of the Powerlink System patients being significantly higher.
• Mean length of hospital stay was 3.3 days for the Powerlink patients versus 9.5 days for the surgical control patients.
• Operative time, blood loss, and ICU stay for Powerlink System patients were significantly lower versus control patients.
• 33% of the Powerlink patients were treated using a regional or local anesthesia.
• During the followup period there was negligible device migration, low endoleak rate, and no reported AAA ruptures, wire form fractures or material failures of the Powerlink System.
• Core lab analysis at 24 months demonstrated that in 98.6% of patients the maximum diameter of the aneurysm sac decreased (63.9%) or remained stable (34.7%).
The Powerlink System is designed to overcome shortcomings associated with earlier-generation, multi-piece bifurcated ELG devices. Among Powerlink System features are:
• A one-piece, bifurcated design that eliminates many of the problems associated with multi-piece bifurcated systems, reducing much of the guidewire manipulation, and thereby simplifying the procedure. Additionally, the one-piece design eliminates risk of limb detachment sometimes associated with multi-piece bifurcated systems. Endologix believes the Powerlink System's design should result in improved, continued, long-term exclusion of the aneurysm.
• The one-piece cobalt-chromium alloy cage lessens the risk of kinking even in tortuous anatomy that could restrict or block blood flow, reducing the need for additional procedures or costly peripheral stents.
• A single-wire main body construction that inhibits late migration, a concern with some multi-piece ELGs.
• A minimally invasive delivery mechanism that requires only a small surgical incision in one leg and percutaneous access in the other leg. ELGs typically require surgical exposure of the femoral artery in both legs to introduce their multiple components. The Powerlink delivery mechanism also permits use in some patients having small or very tortuous access vessels.
Although it is estimated that 15,000-20,000 patients are already being treated by a commercially available ELG, some 60,000 patients undergo conventional open surgery. The company believes that approximately 60% of those could be treated with an ELG.
Additional information about the Powerlink System can be found at www.endologix.com.
Cook Launches Comprehensive Practice Kit Specifically Designed to Support Physicians in AAA Diagnostic and Treatment Services
Cook Incorporated has announced the availability of its Abdominal Aortic Aneurysm (AAA) Physician Practice Builder Kit. Designed to provide a comprehensive set of tools and information, the kit helps health care professionals communicate with their patients about the treatment of AAAs and is also designed to enhance the understanding of AAA among physician referral networks.
Cook's AAA Physician Practice Builder Kit was created to simplify a patient's understanding of aortic aneurysms and their options for treating AAAs. The kit's materials were developed in consultation with leading experts in the field and include, but are not limited to: templates for physician-to-physician introductory and patient follow-up letters; AAA screening instructional sheets; patient education brochures; and a patient video.
Medical Ventures Receives U.S. FDA 510K Clearance to Expand Indications for the Angiometrx Metricath™ System
Medical Ventures Corp.'s Angiometrx division has received U.S. Food and Drug Administration (FDA) 510k clearance allowing it to expand the indications for its Metricath system products to include use in peripheral arteries. This clearance will allow the company and its U.S. distributor to immediately begin marketing the Metricath system for use in the renal, femoral and iliac arteries. The Metricath system is a catheter-based technology that allows cardiologists and radiologists to precisely measure arterial and in-stent size during stent implantation, while treating coronary or peripheral artery disease. The Metricath system has been cleared by the U.S. FDA for use in coronary arteries since 2003.
"This new indication will add significantly to the number of medical procedures in which the Metricath can be used," states Paul Geyer, chief executive officer of Medical Ventures. "These peripheral indications will be particularly valuable for our new four- to eight-millimetre-size catheter which is ideally suited for use when stenting larger peripheral arteries." Annually, about 400,000 procedures are performed in the United States to implant stents in these arteries.
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