Irvine, Calif., medical device maker Reverse Medical Corp. touted FDA clearance for its flagship product, the MVP micro vascular plug for peripheral artery embolization.
The plug helps decrease blood flow in the peripheral vasculature and is "completely re-sheathable" for use in procedures where a patient needs only temporary blood flow reduction.
The latest results from the largest study to date comparing open and endovascular surgery for abdominal aortic aneurysm repair found no difference in long-term survival between the procedures.
The findings called into question the benefit of offering endovascular AAA repair to patients who are too sick to undergo open surgery.
MASSDEVICE ON CALL — IBM’s Jeopardy-winning Watson supercomputer is taking a swing at oncology research in efforts to help hospitals more quickly diagnose and treat cancer.
Watson can cull through 200 million pages of information in less than 3 seconds, according to IBM, and the machine is getting an education in oncology at Manhattan’s Memorial Sloan-Kettering Cancer Center.
A group of consumer advocates demanded that the FDA heighten testing requirements for certain medical devices, taking exception to the agency’s 510(k) clearance of Aptus Endosystems Inc.’s HeliFX endostapling system.
Covidien plc (NYSE:COV) launched a voluntary recall of the entire production lot of its Duet TRS single-use heads for thoracic surgery after the company received reports of 13 serious injuries and 3 deaths following use.
"The company has concluded that Duet TRS has the potential to injure adjacent anatomical structures within the thorax, which may result in life-threatening, post-operative complications," according to a press release.
Spectranetics purchased lines of Kensey Nash’s endovascular products in May 2008. They reached a cumulative $20 million in end-user sales, triggering a $6 million milestone payable to Kensey Nash.
Aptus Endosystems Inc. landed FDA 510(k) clearance for the first repair system designed to fix leaks and migration in implanted endografts.
An endograft is a tube used to repair a bulge in the wall of the large blood vessel that carries blood away from the heart. Aptus’ HeliFX is a minimally invasive system of staples, delivered via catheter, that allows a surgeon to reach the blood vessel and staple the top edges of the endograft to the tissue to anchor it in place.
Cardiovascular Systems Inc. (NSDQ:CSII) is starting a limited-market release of its Stealth 360 Orbital PAD System, the latest in its line of catheter-based systems that rub away plaque in clogged arteries in the pelvis or leg.
St. Paul, Minn.-based CSI claims the Stealth 360 has a simpler, more user-friendly design than previous devices in the company’s Orbital PAD System family — the Diamondback 360 and Diamondback Predator 360.
ArtVentive Medical Group Inc. (OTC:AVTD) froze the design process for its Endoluminal Occlusion device, saying it’s gearing up to seek regulatory approvals ahead of launching the product in Europe and the U.S.
The San Marcos, Calif.-based company it also has its eye on Eastern Europe, Japan, Asia Pacific and Latin America.