Abbott (NYSE:ABT) subsidiary St. Jude Medical won expanded FDA approval today for its Masters Series mechanical heart valve, now cleared in a 15mm size, which the FDA said is the smallest mechanical heart valve approved in the world. The company’s Masters series mechanical heart valve is a rotatable, bileaflet valve designed for implantation in the aortic or […]
Cardiac Implants
Edwards Lifesciences recalls Cardioband anchors
Edwards Lifesciences (NYSE:EW) last month recalled the anchors used with its Cardioband mitral valve repair device after receiving a pair of reports that the device came loose from the surrounding tissue. The Cardioband device, acquired in the $690 million buyout of Valtech Cardio last year, is designed to reshape the mitral valve using specially designed anchors. In a […]
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 […]
ActriCure launches AtriClip Flex V
AtriCure (NSDQ:ATRC) said yesterday that it won 510(k) clearance from the FDA for its AtriClip Flex V left atrial appendage closure device, touting it as the first AtriClip device with a trigger release for deployment. “The AtriClip Flex V is an exciting new product that we are pleased to be releasing to our U.S. customers,” president […]
Study: Abbott’s Nanostim leadless pacers solid at 3 years outside battery redesign issues
Abbott‘s (NYSE:ABT) Nanostim leadless pacemaker was found to be safe and effective after three years, outside of a battery-related malfunction that required a redesign, according to study data reported by Healio. Data came from the first-in-human Leadless study and was published in a research letter in the journal Circulation, according to the report. A single patient […]
Edwards Lifesciences wins CE Mark for Centera TAVR
Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its self-expanding transcatheter Centera aortic heart valve, with indications for treating symptomatic aortic stenosis patients at high risk of open-heart surgery. The Centera valve is designed to be repositionable and retrievable, and is delivered through the use of a 14 French motorized […]
17 black innovators who made medtech better
From cardiology to endoscopy to blood transfusion, African Americans have played an important role as innovators in the history of medicine and medtech. To help mark African American History Month, here’s a look at some of their greatest achievements. Here are 17 black innovators who have made discoveries and invented devices to make medtech better. […]
Procyrion raises $16m in Series C to support Aortix intra-aortic heart pump
Procyrion said earlier this week it raised $16 million in a Series C round of funding to support its Aortix catheter-deployed, intra-aortic heart pump designed for ambulatory use. The round was led by an affiliate of Fannin Partners and joined by existing investors Scientific Health Development, the State of Texas and an undisclosed strategic investor, […]
3 secrets of medtech success from a true industry pioneer
From stents to TAVR, Stanton Rowe has built a medtech legacy out of accomplishing the seemingly impossible. Here are three lessons from his career. Stanton Rowe has played a major role in two of the top medtech innovation success stories of recent decades: stents and transcatheter valve replacements. Listening to him speak at DeviceTalks West […]
Medtronic logs wins in overcharging lawsuit, defibrillator case fees
Medtronic (NYSE:MDT) logged a series of legal wins this week after a federal judge dismissed a whistleblower lawsuit against the medtech titan and the U.S. Supreme Court declined to review a bid over legal fees in a long-running patent spat, upholding Medtronic’s victory from April last year. In a lawsuit brought against Medtronic, Cavallino Consulting alleged […]
Abbott gains on Morgan Stanley upgrade, touts MR conditional FDA labeling
Abbott (NYSE:ABT) shares have risen approximately 1.3% after the company received an upgrade from a Morgan Stanley analyst and won updated MR-conditional labeling from the FDA for two of its cardiac pacing devices. The share price rise came after Morgan Stanley analyst David Lewis yesterday lifted the price target for the company from $60 to $67, […]