Barely four months after being named to the board of CardiAQ Valve Technologies, Robrecht “Rob” Michiels led a group of angel investors in a $6.5 million boon for the Winchester, Mass.-based start-up.
Abbott (NYSE:ABT) won approval from the Japanese Ministry of Health, Labor and Welfare for its Xience V drug-eluting stent.
Abbott said it plans to bring the device to market as soon as it receives final reimbursement authorization from Japanese officials.
It’s not often that a few doctors ensconced in the ivy towers of academia can get a lumbering dinosaur like the Food & Drug Administration to turn on a dime, let alone during the week between Christmas and the new year.
But that’s exactly what University of California at San Francisco researchers Sanket S. Dhruva, Lisa Bero and Rita Redberg did after the Journal of the American Medical Assn. published their paper “Strength of Study Evidence Examined by the FDA in Premarket Approval of Cardiovascular Devices.”
Boston Scientific Corp. (NYSE:BSX) enrolled its first patient in a worldwide trial examining the use of blood thinners in conjunction with drug-eluting stents, joining a trio of other industry giants and their pharmaceutical partners in the study.
Participating in the four-year DAPT Study are Natick, Mass.-based Boston Scientific, manufacturer of the Taxus and Promus stents, along with device makers Medtronic Inc. (NYSE:MDT), Abbott Laboratories (NYSE:ABT) and Cordis Corp., the stents arm of healthcare conglomerate Johnson & Johnson (NYSE:JNJ). Drug-makers Bristol-Myers Squibb Co. (NYSE:BMY), Sanofi Pharmaceuticals (NYSE:SNY), Eli Lilly & Co. (NYSE:LLY) and Daiichi-Sankyo Company Ltd. (TYO:4568) also have signed on for the study.
Medtronic Inc. (NYSE:MDT) tapped veteran British interventional cardiologist Martin Rothman to lead a portion of its vascular business.
The Minneapolis medical device monolith said Rothman will be vice president of medical affairs for its Santa Rosa, Calif.-based coronary and peripheral vascular business, effective Jan. 4. He spent the last 37 years in clinical practice at the London Chest Hospital, where he directed cardiac research and development for the past 10 years.
Thought-powered robotic hand unveiled: LifeHand, a European project to develop an implanted, electrode-controlled prosthetic hand just showed off its first human subject, who used the device for an entire month. Unlike with many other prostheses, Pierpaolo Petruzziello was able to use pure thought to move the fingers of the hand and perform fairly advanced tasks.
The U.S. Supreme Court has declined to weigh in on a dispute between Boston Scientific Corp. and the Cordis unit of Johnson & Johnson, effectively allowing a pair of trial-court juries to determine damages in the companies’ long fight over stent designs.
The nation’s high court without comment Monday denied bids by the companies to review a March 31 ruling by a three-judge federal appeals panel that mostly upheld separate 2005 jury decisions that both companies had infringed on the other’s patents. The appeal judges also kicked back any decisions on damages to the trial courts.
Boston Scientific Corp. (BSX) won 510(k) clearance from the U.S. Food and Drug Administration and CE Mark approval for its WallFlex fully covered esophageal stent.
The Natick, Mass.-based medical devices monolith’s latest stent is designed to treat malignant esophageal obstructions caused by esophageal cancer. A partially covered version of the device won 510(k) clearance and a CE Mark last year.
Sales of Boston Scientific Corp.‘s Taxus drug-eluting stent have been declining since 2006, according to restated earnings reports from Angiotech Pharmaceuticals Inc., which makes paclitaxel, the drug used in the stent’s coating.
The Vancouver-based pharmaceutical company’s drug is designed to reduce restenosis, or the re-narrowing of blood vessels after stents are implanted. Angiotech reaps just under 7 percent of the net sales of Taxus stents worldwide, in royalties for BSX’s use of its product.
Hard on the heels of its Beantown-based rival, Boston Scientific, Abbott announced CE Marks for its Xience Prime and Xience V drug-eluting stents, clearing the way for their use in treating diabetes in the European Union.
The news follows BSX’s announcement of CE Marking for its Promus Element stent.
Chicago-based Abbott said EU regulators clearing its devices for use in treating coronary artery disease in difficult-to-treat diabetic patients, who tend to have smaller blood vessels and longer lesions.