The highly critical “Implant Files” report overseen by the International Consortium of Investigative Journalists skewers the medtech industry as a whole and singles out particular companies and regulatory agencies for more intense scrutiny. The Implant Files is the second large-scale swipe at the medtech industry this year, following Netflix’s documentary, The Bleeding Edge. It includes six stories about […]
Cardiac Implants
Edwards Lifesciences wins CE Mark for Sapien 3 Ultra TAVR
Edwards Lifesciences (NYSE:EW) said today it won CE Mark approval in the European Union for its Sapien 3 Ultra transcatheter aortic valve replacement system intended for patients with severe, symptomatic aortic stenosis. Despite winning a CE Mark, Edwards said that the new valve will not be launched in Germany due to a preliminary injunction from rival […]
Medtronic backs infant-sized miniature pacer
Medtronic (NYSE:MDT) is collaborating with researchers at the Children’s National Health System to develop a miniature pacemaker intended for use with infants. The prototype version of the device was presented at the American Heart Association’s 2018 Scientific Sessions by Dr. Rohan Kumthekar of the Sheikh Zayed Institute for Pediatric Surgical Innovation, part of the Children’s National […]
Biotronik receives FDA approval for covered coronary stent
Biotronik has received FDA approval for its PK Papyrus covered coronary stent system. The PK Papyrus coronary stent system is a balloon-expandable covered stent that is placed in the coronary artery using a balloon catheter delivery system. The stent system is designed to treat tears in heart blood vessels, known as coronary artery perforations. It […]
The top 10 medical disruptors of 2019
The Cleveland Clinic for the past 16 years has predicted what the top 10 medical disruptors will be for the following year. The health provider seeks input from 150 to 200 of its physicians, hailing from each of its institutes. The result is 300 to 400 suggestions, which the clinic then narrows down to 150. […]
FDA approves Abbott’s HeartMate 3 as a destination therapy
Abbott (NYSE:ABT) said today it won FDA approval for its HeartMate 3 left ventricular assist device, now approved as a destination therapy for patients with advanced heart failure. With the approval, the Chicago-based company said that the device can now be used in patients not eligible for a transplant as a life-long implant. “We partner with […]
Cardiac Dimensions wins German reimbursement for Carillon mitral repair device
Cardiac Dimensions said today that it won reimbursement from Germany’s Institute for the Hospital Remuneration System (InEK) for its Carillon mitral contour system intended to treat patients with functional mitral regurgitation. The Kirkland, Wash.-based company’s percutaneous Carillon device is designed to use a distal anchor and proximal anchor, connected by a shaping ribbon, to re-form the mitral […]
Neovasc touts Tiara TMVR success rate in study
A small study of the Neovasc (NSDQ:NVCN) Tiara transcatheter mitral valve replacement (TMVR) in high-risk patients revealed a 100% procedural success rate and immediate elimination of mitral regurgitation. Published in Circulation: Cardiovascular Interventions, the study also showed no death, myocardial infarction, stroke, major bleeding, or access site complications at 30 days. The twelve patients in the study […]
Micro Interventional Devices begins study of tech for heart valve repair
The first patient in the transcatheter arm of a European study has been treated with Micro Interventional Devices’ MIA technology for tricuspid and mitral repair, the company said. A team at Vilnius University Hospital Santariskiu Clinic (Vilnius, Lithuania) used the 12F MIA (minimally invasive annuloplasty) delivery catheter and PolyCor anchors to reduce tricuspid annular dimensions and […]
Abiomed claims Impella pump not at fault in patient death
Update: Includes statement from Abiomed After reporting possible issues with two of its Impella heart pumps used in an open heart surgery, Abiomed (NSDQ:ABMD) said today that the devices were not to blame for the patient’s death. The Impella devices were used in a last-attempt effort to save an elderly patient undergoing open heart surgery, Abiomed CEO […]
Report: Medtronic shuts down pacer programmer updates on hacking risk
Medtronic (NYSE:MDT) has disabled internet updates for approximately 34,000 CareLink devices designed for accessing and programming implanted pacemakers due to cybersecurity vulnerabilities with the systems, according to a Reuters report. The vulnerability, revealed this summer by cybersecurity firm researchers, could allow an outside agent to plant malware on the pacers that would allow them to […]