Rival medical device makers St. Jude Medical (NYSE:STJ) and Boston Scientific (NYSE:BSX) each touted clinical advances this week.
Structural Heart
Edwards loses nearly 5 percent on FDA rumor
Shares of Edwards Lifesciences (NYSE:EW) bounced back today after losing nearly 5 percent yesterday on speculation that FDA approval of its next-generation Sapien heart valve could be delayed.
Edwards shares closed at $68.53 yesterday, down 4.8 percent from its $72 close the day before. EW shares were trading at $69.73 as of about 1:15 today, up nearly 1.8 percent.
Stents: Cook Medical’s Evolution lands FDA clearance
Cook Medical landed 510(k) clearance from the FDA for its Evolution duodenal controlled-release stent for the treatment of malignant gastric outlet obstruction.
Meant for use in patients with pancreatic or GI-related cancers, the stent offers relief of abdominal pain, vomiting, malnutrition and aspiration associated with obstructions in the intestinal tract.
New Stent Provides Relief to Patients with Advanced Small Intestine Cancer
WINSTON-SALEM, N.C.–(BUSINESS WIRE)–Cook Medical announced today that its Evolution® Duodenal Controlled-Release Stent was recently granted 510(k) clearance by the Food & Drug Administration (FDA). This new stent expands palliative care options for patients experiencing issues associated with malignant gastric outlet obstruction (GOO), a late stage complication of a variety of GI related cancers with pancreatic cancer being the most common cause.1 Studies indicate that as many as 50 percent of the malignancies involving the small intestine, including pancreatic, gastric, duodenal and cholangiocarcinoma, occur in the duodenum,1 the part of the small intestine connected to the stomach.
FDA: New draft guidance for external pacemaker pulse generators
The FDA has proposed a draft guidance to lower the risk classification for external pacemaker pulse generators from class III to class II.
External pacemaker pulse generators are used after heart surgery or heart attack as a bridge until the patient has a permanent pacemaker implanted.
The federal watchdog agency’s proposed move would lower external pacemaker pulse generators from high-risk to moderate-risk medical devices, removing them from the 22 remaining class III preamendment medical devices regulated through 510(k) premarket submission rather than the premarket approval required for other class III devices.
Update: Boston Scientific launches Promus Element drug-eluting stent in China
Updated October 17, 2011 at 1:00 p.m. to correct that the Promus Element was launched in China, rather than the Promus stent.
Boston Scientific Corp. (NYSE:BSX) launched it’s Promus Element drug-eluting stent into China, one of the world’s fastest growing DES markets.
Boston Scientific launches Promus stent in China
NATICK, Mass., Oct. 17, 2011 /PRNewswire/ — Boston Scientific Corporation (NYSE: BSX) has begun a phased launch of its PROMUS Element™ Everolimus-Eluting Platinum Chromium Coronary Stent System in China. The launch campaign will be expanded within the country based upon receipt of subsequent provincial reimbursement approvals. The Company previously received registration approval for the PROMUS Element™ Stent System from the State Food and Drug Administration (SFDA) of the People’s Republic of China.
Medtronic’s two next-gen stent systems launch in Japan
Medtronic Inc. (NYSE:MDT) plans to launch two next-generation stent systems in Japan as the devices won regulatory approval and reimbursement from the country’s Ministry of Health, Labor & Welfare.
The Integrity coronary stent’s reimbursement took effect on Sept. 1 and the Endurant AAA stent graft’s reimbursement is set to take effect Nov. 1.
Medtronic wins Japanese reimbursement for two next-gen stents
MINNEAPOLIS–(BUSINESS WIRE)–Medtronic, Inc. (NYSE: MDT) today announced plans to introduce two of its next-generation cardiovascular devices in Japan, the world’s second largest market for advanced medical technology: the Integrity® Coronary Stent System for the treatment of narrowed heart arteries due to atherosclerosis and the Endurant® AAA Stent Graft System for the treatment of abdominal aortic aneurysms.
“The Endurant stent graft has become an extremely popular device everywhere it’s available”
Whistleblowing doc fired, MDUFMA, Cook’s stent, KCI patent spats, Think tank blasts FDA, State of med-tech, Army doc fined | MassDevice.com +7
Say hello to MassDevice +7, a bite-sized view of the top seven med-tech stories of the week. This latest feature of MassDevice.com’s coverage highlights our seven biggest and most influential stories from the week’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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VC roller coaster, Did Steve Jobs stubbornness kill him?, Cook’s stent gets the green light | MassDevice.com +3
Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This latest feature of MassDevice.com’s coverage highlights our three biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.
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