The FDA has yet another private listing of device-related deaths, this one for transcatheter aortic valve replacement (TAVR) devices that include Medtronic’s (NYSE:MDT) CoreValve and Edwards Lifesciences’ (NYSE:EW) Sapien 3 lines, according to a new report by Kaiser Health News. Both devices were initially indicated for patients who were too frail or ill for open-heart surgery, but the FDA subsequently approved […]
FDA aims to publicly report information on Watchman-related deaths
This article has been updated with comments from the American College of Cardiology. The FDA said Thursday that it plans to make public information on four patient deaths linked to Boston Scientific’s (NYSE:BSX) Watchman heart implant once it receives that information from the company. The agency said it has asked the sponsor of a Watchman […]
Hacking pacemakers is good TV, but is it for real?
Worry less about bad people hacking pacemakers and other cardiac devices. Worry more about them disrupting hospitals’ communications networks. That’s the major message out of the American College of Cardiology’s Electrophysiology Council, which published an article about cardiac devices earlier this month in the Journal of the American College of Cardiology. The idea that hackers might […]
UPDATE: Medical societies update stroke guidelines
A bevy of cardiac medical societies updated their guidelines for stroke treatment yesterday to take into account new devices and technology, including left atrial appendage occlusion devices, stent retrievers and thrombectomy devices. The American College of Cardiology, Heart Rhythm Society and Society for Cardiovascular Angiography and Interventions have updated their guidelines to include the benefits of left […]
Widowmaker: Stents as safe as open heart surgery in left main artery disease
A long-term Korean study found stents as safe as open heart surgery in treating blockages of a coronary artery known as the widowmaker, showing that stented patients did not run a significantly higher risk of suffering a heart attack or stroke.
ACC 2015 Roundup: CTA no benefit, Abbott’s MitraClip, Philips’ IntelliSpace
A large clinical trial comparing computed-tomography angiography with functional testing found no benefit to clinical outcomes with CTA, which also exposes patients to large doses of radiation.
ACC 2015: Danish study finds TAVI safe for low-risk patients
(Reuters) — Transcatheter aortic valve implantation is safe for low-risk patients, according to a study presented at the American College of Cardiology meeting in San Diego.
ACC 2015: Medtronic readies ‘drug-filled stent’ trial
ACC 2015: St. Jude Medical’s CardioMEMS HF lowers mortality, hospitalizations
TAVI: Strong results for heart valves from Edwards Lifesciences, Medtronic
Transcatheter aortic valve implants once again took the spotlight at the annual meeting of the American College of Cardiology, with a spate of studies both confirming the long-term benefits of the replacement heart valves and showing that newer TAVI versions are even better.
Boston Scientific’s Watchman misses 1 of 2 efficacy goals in PREVAIL trial
Boston Scientific (NYSE:BSX) this week unveiled full results from the PREVAIL clinical trial of the Watchman anti-stroke implant, largely agreeing with earlier reports that the device missed a co-primary endpoint for efficacy.
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