Cook Medical's Zilver PTX Stent Gains CE Mark to Treat SFA
August 11, 2009—Cook Medical (Bloomington, IN) announced that CE Mark approval has been granted for its Zilver PTX paclitaxel-eluting peripheral stent to treat severe blockages in the superficial femoral artery. The Zilver PTX is a polymer-free nitinol device. The company noted that without polymer, the device allows targeted delivery of the drug and avoids the potential risks to the patient posed by leaving a permanent, foreign, plastic substance in the body. Physicians conducted the first commercial implantations of the Zilver PTX stent in the United Kingdom, Germany, France, Holland, Belgium, Sweden, Switzerland, and Spain in a coordinated effort. In the United States, the Zilver PTX drug-eluting stent is an investigational device that is not available for sale, the company advised.
According to Cook Medical, the Zilver stent's durability, which was demonstrated in a 1,200-patient worldwide clinical trial, allows for enhanced patient safety. The data collected in the Zilver PTX registry included 791 patients from Europe, Russia, Canada, and Korea, and demonstrated highly positive results. Only 8% of patients with de novo lesions needed a reintervention to reopen the artery in the first 12 months. The company stated that this rate significantly surpasses existing treatments for peripheral arterial disease in the superficial femoral artery, such as balloon angioplasty and bare-metal stents.
Also, specific patient groups that are hard to treat, including diabetics and patients with in-stent restenosis, were shown in the trial to benefit from the Zilver PTX. The trial data indicated that the results achieved in the first year have been largely maintained through 24 months. In comparisons with other trials published, the Zilver PTX stent showed a reduction in reintervention of 50% to 75%, the company stated.
"This global study proves that the Zilver PTX has the integrity, safety, and durability needed to successfully address many of the well-known limitations of current treatments for the management of peripheral arterial disease," commented Michael Dake, MD.
Reverse Medical's ReCruit Microcatheter Cleared for Neurointerventions
August 14, 2009—Reverse Medical Corporation (Irvine, CA) announced that it has received US Food and Drug Administration 510(k) clearance for its ReCruit microcatheter, which is intended to retrieve intravascular foreign objects during interventional procedures, including from the neurovasculature. With this regulatory clearance for United States marketing, the company said that it would closely manage initial clinical use of the device to collect data demonstrating its clinical value compared to competitive products before broad commercialization efforts commence in early 2010.
"I believe the ReCruit microcatheter is a very innovative device that will serve as a platform technology for even more advanced interventional neurovascular devices," commented Satoshi Tateshima, MD. "As a neurointerventionist, the ability for me to control the distal tip rate of radial deployment is quite unique and represents a significant improvement over other devices I have used. Furthermore, the device's superior flexibility allows for deep brain navigation through tortuous anatomy, and the infusion capability adds additional options for advanced site-specific use."