The Fridley, Minn.-based medical device giant’s device, which is delivered via catheter through the femoral artery, won CE Mark approval in the European Union in 2008 and is in use in roughly 100 countries, according to Medtronic.
UPDATE: Dec. 8 2010, 9:15 A.M.
Emails from executives at Abbott Laboratories (NYSE:ABT) show company leaders’ approved and encouraged the high number of stent procedures that eventually precipitated a federal fraud lawsuit.
OrbusNeich Medical Inc. hailed the decision of a Dutch court in its ongoing stent patent spat with Boston Scientific Corp. (NYSE:BSX).
The District Court of The Hague, Netherlands ruled that Boston Scientific’s lawsuit accusing Orbus of infringing a Boston Scientific patent with its Evolution 2 catheter could not proceed, according to Orbus.
Cordis Corp., the stent-making division of Johnson & Johnson (NYSE:JNJ) inked a worldwide distribution deal with Ostial Solutions for a stent-positioning system designed to treat aorto-ostial blockages.
Kalamazoo, Mich.-based Ostial makes the Ostial Pro stent positioning system, which it sells in the U.S. Under the terms of the deal with Bridgewater, N.J.-based Cordis, the J&J subsidiary plans to roll the system out worldwide during the first half of 2011.
Medtronic Inc. (NYSE:MDT) said Friday a pivotal clinical trial testing its experimental Endurant stent showed promising results for treating abdominal aortic aneurysms after one year.
The Fridley, Minn.-based company said results from the study of 150 patients across the United States also proved Endurant is safe and effective after 30 days.
“The device has met its goals,” Tony Semedo, vice president and general manager of the endovascular innovations division at Medtronic, said in an interview.
Boston Scientific Corp. (NYSE:BSX) agreed to acquire Sadra Medical Inc. in a deal worth $450 million.
The acquisition of Los Gatos, Calif.-based Sadra marks the medical device giant’s entry into the aortic valve replacement market. Sadra is developing a device, the Lotus valve system, that’s designed to replace the valve that can be deployed via catheter; Boston Scientific became a strategic investor in the company in 2005 and owns 14 percent of Sadra, according to a press release.
St. Joseph Medical Center in Baltimore agreed to pay $22 million to the federal government to settle a whistleblower lawsuit accusing it of bilking Medicare for un-necessary coronary stent implantations.
The lawsuit, which was under seal until Nov. 9, was filed by a trio of cardiac surgeons who alleged that the hospital and an independent practice, MidAtlantic Cardiovascular Associates, ran a 10-year scheme to drive referrals from St. Joseph to MACVA.
Edwards Lifesciences Corp. (NYSE:EW) revealed yesterday a U.S. Attorney’s Office for Central California subpoena for documents related to its 2006 heart monitor recall.
The Irvine, Calif.-based cardiac device maker said the court communication came "in connection with an investigation by the federal Food & Drug Administration," and sought "records relating to the Vigilance I Monitor model with software release 5.3 that was the subject of a voluntary field recall by the Company in June 2006."
The AARP is signing on to a whistleblower lawsuit accusing some of the biggest players in the medical devices arena of promoting the off-label use of biliary stents to treat cardiovascular disease in hundreds of thousands of patients.
St. Joseph Medical Center in Baltimore and a former cardiologist at the hospital are facing 101 complaints from patients who may have implanted with un-necessary coronary stents.
In January, the hospital notified 369 patients that they may not have needed the stent procedures they underwent. That prompted federal officials to investigate the Towson, Md. hospital for healthcare fraud, with now-former St. Joseph’s cardiologist Dr. Mark Midei the only doctor implicated.
A group representing former shareholders of Angiotech Pharmaceuticals Inc. (NSDQ:ANPI) subsidiary Quill Medical Inc. are suing both companies.