Medical device titan Medtronic (NYSE:MDT) is the only company with the green light from U.S. healthcare regulators to market a drug-eluting stent specifically for patients with diabetes in addition to coronary artery disease, but that victory was hard-won.
Structural Heart
Patients slap St. Jude Medical with lawsuits over recalled Riata heart wires
Pennsylvania heart docs quits amid excess stenting scandal | MassDevice.com On Call
MASSDEVICE ON CALL — Pennsylvania Hospital has remained rather closed-lipped about the excess stenting scandal that resulted in the resignation of one of its cardiologists, but at least 1 patient sprang to the defense of accused cardiologist Dr. Vidya Banka.
The doctor is under investigation by the hospital over "concerns about the appropriateness of some cardiac stent placements," according to a Pennsylvania Hospital statement.
Symetis touts positive findings for its Acurate TA TAVI system
Swiss medical device maker Symetis released 30-day registry findings for its 2nd-generation transcatheter aortic valve implantation systems, touting high procedural success rates and minimal valve leakage.
Results from the SAVI postmarket registry highlighted findings from the 1st 250 patients implanted with Symetis’ Acurate TA TAVI system, which won European regulatory approval in September 2011.
J&J’s Cordis escapes $593M stent patent infringement loss
Johnson & Johnson (NYSE:JNJ) logged a major win for its Cordis stent-making arm today when a federal appeals court overturned a lower court decision to award more than $593 million to stent pioneer Dr. Bruce Saffran for patent infringement.
Saffran alleged that Cordis violated his patent with the Cypher drug-eluting stent, leading to a jury trial that went Saffran’s way.
FDA’s new global cardiovascular registry to start with transcatheter heart valves
The FDA plans to launch a global cardiovascular medical device registry, with initial efforts to focus on coordinated efforts to monitor transcatheter heart valve technology.
The federal watchdog agency will host a public meeting later this month to discuss goals and strategies for organizing such an effort, which the FDA is calling the "International Consortium of Cardiovascular Registries."
Abbott Vascular warns on MitraClip
Abbott Vascular (NYSE:ABT) warned physicians about the slight risk that its MitraClip heart valve implant could be damaged if the device is misapplied during implantation.
Heart valves: St. Jude Medical champions Trifecta data
St. Jude Medical (NYSE:STJ) championed newly published results from the 4-year-old study it used to back its pre-market approval application for the Trifecta heart valve in The Journal of Thoracic and Cardiovascular Surgery.
FDA panel splits on Abbott’s MitraClip heart implant
FLASH: FDA panel votes 5-3 that benefits of Abbott’s MitraClip heart implant outweigh the risks
The FDA’s Circulatory System Devices Panel voted today to make its recommendation regarding Abbott’s (NYSE:ABT) premarket approval application for the MitraClip heart implant, agreeing unanimously that the device is safe but issuing a mixed result on the effectiveness and potential risks of the device.
Syncardia reels in $19M for artificial heart
Syncardia put together a $19 million financing package to back the spinout of its total artificial heart technology, hard on the heels of an FDA win for the device.
The bulk of the financing, $15 million, was doled out by New York-based funding group Athyrium Investors, with the balance coming from existing backers.