Structural Heart
Cook notches a U.S. 1st with FDA approval for Zilver PTX peripheral artery DES
Cook Medical finally own premarket approval for its Zilver PTX stent, making it the 1st drug-eluting stent approved by the FDA for treatment of peripheral artery disease.
The approval comes 1 year after the FDA’s Circulatory Systems Devices Panel unanimously recommended approval for the device, which is a self-expanding drug-eluting stent coated in paclitaxel.
Biotronik touts IDE approval, 1st implant for Pulsar-18 stent in Bioflex-I trial
Cardiovascular medical device maker Biotronik touted FDA investigational device exemption for and 1st U.S. implantation of its Pulsar-18 self-expanding stent, the latest in the company’s line of peripheral artery stents.
The FDA approval granted the Lake Oswego, Ore.-based company approval to add U.S. patients to its prospective, non-randomized study of the Pulsar-18 stent in the BioFlex-1 trial, which also includes centers in Europe and Canada, according to a press release.
Appeals court upholds $74M Edwards Lifesciences win over Medtronic
UPDATED Nov. 13, 2012, 5:30 p.m. with comment from Medtronic
UPDATED Nov. 13, 2012, 2:30 p.m. with comment from Edwards Lifesciences
A pacemaker powered by a heartbeat | MassDevice.com On Call
MASSDEVICE ON CALL — University of Michigan engineers believe they have developed a battery system that can power a pacemaker or other implantable cardiac device using the electrical energy generated by a beating heart.
In lab experiments using a prototype system and a heartbeat simulator, the device generated far more than enough power to support a modern pacemaker, according to a press release.
The researchers hope to incorporate their technology into commercial pacemakers, but have a ways yet to go. The next step involves implanting the so-called "energy harvester."
CardiAQ Valve Tech raises $33M for mitral valve replacement
Transcatheter valve maker CardiAQ Valve Technologies raised $33.2 million, successfully closing an equity funding round launched late last month.
CardiAQ, a privately held device maker developing transcatheter mitral valve replacement technology, did not disclose the names of investors.
TAVI: Mixed results for Edwards’ Sapien valve in latest Partner analysis
Newly unveiled results from Edwards Lifesciences (NYSE:EW) transcatheter aortic valve studies showed mixed results for its Sapien TAVI system when compared with surgical aortic valve replacement.
Open heart surgery beats stents in 5-year Freedom trial
Patients with diabetes and multi-vessel heart disease did better with cardiac bypass surgery than patients treating using drug-eluting stents, according to a 5-year study comparing the therapies.
The Freedom trial found that the CABG arm of the 1,900-patient study had fewer adverse events and lower mortality rates than the percutaneous coronary intervention cohort.
Direct Flow’s next-gen inflatable TAVI looks good at 30 days
Medical device maker Direct Flow Medical unveiled 30-day results for its namesake transcatheter aortic valve implantation system, touting reduced valve leakage and procedure-related complications for the inflatable device.
In the study, which will enroll up to 100 patients, Direct Flow’s TAVI met primary mortality endpoints with zero incidents of major vascular complications and with 95% of patients experiencing mild or less paravalvular regurgitation.
TAVI: Medtronic’s next-gen Engager looks good in 1st pivotal study results
St. Jude Medical slides on negative results from heart implant trial
St. Jude Medical (NYSE:STJ) shares lost 4% today after studies of its Amplatzer heart implant failed to significantly reduce cryptogenic stroke compared with standard treatment with drugs.