EV3 announced plans to assess atherectomy as a stand alone intervention using their device, the silverhawk device. Its been a long time coming to get some data on short and midterm results of percutaneous atherectomy using a core lab. It will be interesting to see the details of the study design and lesion inclusion. This comes on the heels of the launch of LifePath's G2 Jetstream device.
On thing is for sure, if the results are good, every atherectomy company will piggy back and if the results are bad-"Our device is better than EV3's"
EV3 Commences DEFINITIVE LE Postmarket Study of SilverHawk
April 30, 2009—ev3 Inc. (Plymouth, MN) announced that the first patients were enrolled in the company's DEFINITIVE LE postmarket study of stand-alone SilverHawk plaque excision therapy for the endovascular treatment of lower extremity peripheral arterial disease (PAD). DEFINITIVE LE is a prospective, multicenter, single-arm study that will evaluate the intermediate and long-term effectiveness of the therapy. The study is expected to enroll up to 800 patients from 50 clinical sites in the United States and Europe. It will evaluate 1-year patency in patients with claudication and 1-year limb salvage in patients with critical limb ischemia. A third-party review of the results by independent core labs will also be included in the study. James McKinsey, MD, and Lawrence Garcia, MD, are coprincipal investigators for DEFINITIVE LE.
According to ev3, the DEFINITIVE LE study represents the second study in the company's DEFINITIVE clinical study program to confirm the value of plaque excision with the SilverHawk system. A United States investigational device exemption study, called DEFINITIVE Ca++, is currently being conducted to evaluate the use of the SilverHawk-R LSC (RockHawk) plaque excision system and the SpiderFX embolic protection device in the endovascular treatment of moderate-to-heavily calcified peripheral artery lesions.
"DEFINITIVE LE will provide much needed guidance on the treatment of PAD using plaque excision in both above- and below-the-knee applications," commented Dr. Garcia. "Furthermore, this study will potentially add new insight on the optimal management of diabetic patients in this very difficult vascular territory."
A great man is always willing to be little.
Posted by: new jordans | November 08, 2010 at 12:55 AM
Life is tough, we must be stronger*_*
Posted by: chaussure de basket | December 02, 2010 at 02:18 AM