Cordis Corp., the stenting arm of Johnson & Johnson(NYSE:JNJ), announced regulatory wins in the U.S. and the E.U. for new sizes of its Sleek OTW balloon catheter, used to clear clogged arteries below the knee and prevent lower limb amputations.
Structural Heart
Edwards Lifesciences wins Japanese approval for next-gen Sapien XT heart valve
Edwards Lifesciences (NYSE:EW) won the green light from Japanese regulators for its Sapien XT transcatheter aortic heart valve system, the 1st device of its kind to hit the shelves in the island-nation.
The law of unintended consequences: Transparency rules may harm sickest patients | MassDevice.com On Call
MASSDEVICE ON CALL — A new study out of Brigham & Women’s Hospital in Boston suggests that transparency rules might have negative consequences for very sick heart patients.
The study evaluated the frequency of coronary stent implantation in 116,227 Bay State patients, finding that "outlier" hospitals – pegged for having higher-than-average death rates – were less likely to accept the sickest patients.
Edwards Lifesciences’ Perimount heart valve fares well in 25-year study
The Perimount aortic valve implant made by Edwards Lifesciences (NYSE:EW) lasts about 17 years post-implantation, according to 25-year data from a study of the valve in patients younger than 60.
Abbott kicks off a Japanese trial for its “dissolving” vascular scaffold
J&J’s Cordis lands FDA win for next-gen Adroit guiding catheter
Cordis Corp., the stent-making division of Johnson & Johnson (NYSE:JNJ), landed a new U.S. regulatory win for its next-generation Adroit 6F Guiding Catheter, which the company said can handle more sophisticated cases than earlier versions.
Medtronic notches small win in German TAVI war with Edwards Lifesciences
How to simplify consents
Kentucky cardiologist confesses to unnecessary stenting
Kentucky-based cardiologist Dr. Sandesh Rajaram Patil, 51, admitted this week that he lied about a patient’s heart health in order to justify implanting a stent and submitting a claim for federal reimbursement. Patil is the 3rd cardiologist nationwide and the 1st from Kentucky to face federal prosecution for unnecessary cardiac stenting.
Cook Medical lands FDA win for Evolution biliary gastrointestinal stent
Medical device maker Cook Medical won FDA clearance for its Evolution biliary stent, the latest in the company’s line of controlled-release stents designed for use in the gastrointestinal tract.
Like the rest of the Evolution line, the newly cleared biliary stent delivery system includes recapture technology that allows physicians to modify the stent’s placement before full deployment.