Abbott (NYSE:ABT) warned surgeons earlier this month about a potential issue with its MitraClip after receiving 9 reports of problems that led to surgical interventions. In a Feb. 4 urgent field safety notice, Abbott Vascular said the reports indicated that the delivery system for the MitraClip device, which is designed to repair the heart’s mitral […]
Cardiac Implants
China’s JC Medical touts 1st TAVI implant outside the People’s Republic
Chinese device firm JC Medical said today that the 1st implantation of its J-Valve bioprosthesis transcatheter aortic valve implant was performed outside China in Vancouver, Canada. The patient in the operation suffered from heart failure due to severe aortic regurgitation and was considered high risk for open-heart aortic valve replacement surgery due to the condition. “The […]
Reva pulls in $11.4m, updates on Fantom II trial enrollment
Reva Medical (ASX:RVA) this month gave an update on its Fantom II trial, which has reached its target enrollment of 110 patients for its 1st cohort, and announced an incoming $11.4 million through a sale of shares to Goldman Sachs International. The 110 patients make up the 1st cohort of the company’s trial investigating its Fantom […]
Medtronic wins CE Mark for line of MR-safe CRT-Ds
Medtronic (NYSE:MDT) said today it won CE Mark approval in the European Union for its full line of magnetic resonance imaging safe cardiac resynchronization therapy defibrillators, now approved for use with 3 Tesla MRI machines. The approval includes Fridley, Minn.-based Medtronic’s Claria MRI quad CRT-D SureScan, Amplia MRI quad CRT-D and Compia MRI quad systems, which […]
Medicare contractor won’t cover St. Jude Medical’s CardioMEMS heart monitor
A Medicare contractor last week said it would not cover the CardioMEMS implantable heart monitor made by St. Jude Medical (NYSE:STJ), citing the need for more clinical data on the device. Novitas, a Medicare Administrative Contractor that covers patients in Pennsylvania, New Jersey, Maryland, Delaware, Colorado, Oklahoma, New Mexico, Texas, Arkansas, Louisiana, Mississippi and and Washington, D.C., said it […]
FDA panel recommends deep, long-term monitoring for leadless pacemakers
An FDA advisory panel yesterday recommended deep, long-term surveillance of the leadless pacemakers being developed by the 4 leading companies in the cardiac rhythm management space. Medtronic (NYSE:MDT), St. Jude Medical (NYSE:STJ), Boston Scientific (NYSE:BSX) and Biotronik are all developing versions of a leadless pacemaker designed to be implanted directly into the heart’s right ventricle, eschewing the need […]
AtriCure launches AtriClip trial
AtriCure (NSDQ:ATRC) said today that it’s launching a clinical trial of its AtriClip left atrial appendage closure device, aiming to show whether the device reduces the incidence of post-operative atrial fibrillation after cardiac surgery to repair a structural heart defect. West Chester, Ohio-based AtriCure said the 1st patient in the 1-year Atlas trial was enrolled at PinnacleHealth […]
Direct Flow debuts transcatheter mitral valve
Direct Flow Medical said yesterday it premiered its transcatheter mitral valve, developed as part of its TMV development program. The debut was made at the 2nd annual Zurich Heart Team Mitral Valve meeting. The valve is designed to be repositionable and retrievable, and is built upon Direct Flow’s transcatheter aortic valve, the Santa Rosa, Calif.-based company […]
Valtech touts German reimbursement win for Cardioband
Valtech Cardio said Tuesday it won reimbursement in Germany for its Cardioband Mitral Reconstruction System designed to treat mitral regurgitation in heart failure patients. The Cardioband system is composed of a reconstruction implant and a transfemoral, transseptal delivery system. The suture-less implant is connected to the mitral annulus using specially designed anchors, and the mitral […]
Biotronik wins Japanese clearance for MR-safe Itrevia CRT-D
Biotronik said today it won Japanese regulatory clearance for its Itrevia 7 HF-T cardiac resynchronization therapy defibrillator, now approved for full-body MRI-scanning. With the clearance, physicians in Japan are now cleared to perform MRI scans at 1.5 tesla strength on patients implanted with the Itrevia CRT-D. “In addition to having indispensable diagnostic information in the field […]
Boston Scientific wins CMS coverage for Watchman LAAC
Boston Scientific (NYSE:BSX) said late yesterday it won coverage from the Centers for Medicare and Medicaid Services for left atrial appendage closure therapies using its Watchman device. The device and LAAC procedure will be available to patients who meet certain criteria, outlined in the CMS final National Coverage Determination, Marlborough, Mass.-based Boston Scientific said. “We are very […]