Abbott (NYSE:ABT) said today it won approval from the Japanese Ministry of Health, Labor and Welfare for its Absorb bioresorbable heart stent, touting it as the 1st fully dissolving heart stent approved in the country. The stent is now cleared for use in patients with coronary artery disease, the Chicago-based company said, with approval coming […]
Cardiac Implants
LVAD dev CorWave raises $17.1m in Series B
Circulatory support device developer CorWave said today it raised $17.1 million in a Series B round of financing to support its novel left ventricular assist device. The round was led by new investor Novo Seeds, joined by existing shareholders Sofinnova Partners, Bpifrance and Seventure and joined by new investor Ysios Capital. CorWave said it has […]
TCT 2016: Structural heart, drug-coated balloons take their turn on Day 3
The annual Transcatheter Cardiovascular Therapeutics conference is under way in Washington, D.C., with late-breaking study results beginning Oct. 29. We’ll update this post throughout the day as new results come in, so be sure to check back for the latest news out of TCT 2016. After stents took center stage Day 1, with a raft of […]
Report: St. Jude sold off older CRM devices after learning of battery issue
Updated: Corrected date of recall from 2015 to October 2016. St. Jude Medical (NYSE:STJ) continued to distribute outdated pacemaker devices that were indicated in a recall due to battery faults, even after correcting the flaw and producing new units, according to a StarTribune report. The devices were recalled last month over issues with batteries failing with […]
FDA posts another Class I HeartWare HVAD recall
The FDA today posted a Class I recall notice for select Medtronic (NYSE:MDT) HeartWare ventricular assist device controllers over issues with loose power connectors that could stop the pump from functioning. A Class 1 indication from the federal watchdog indicates “a reasonable probability that use of these products will cause serious adverse health consequences or death,” according […]
St. Jude wins FDA nod for Amplatzer PFO occluder
St. Jude Medical (NYSE:STJ) today won FDA approval for its Amplatzer patent foramen ovale occluder device, designed to reduce the risk of stroke in patients who’ve experienced a PFO-related stroke. Approximately 25-30% of Americans have a PFO, according to the FDA, which typically causes no health problems and does not require treatment. While the cause of […]
St. Jude calls global stop to Nanostim implants over battery issues
St. Jude Medical (NYSE:STJ) said today it is pausing the implantation of its Nanostim leadless pacemaker due to reports of battery related problems with electronic data reporting. The Little Canada, Minn.-based company said it pulled implants of the micro-sized, catheter-delivered Nanostim after receiving 7 reports of “lost telemetry and pacing output.” The company clarified that there […]
Medtronic wins FDA nod for CoreValve Evolut TAVR system
Medtronic (NYSE:MDT) said today it won FDA approval for its CoreValve Evolut R 34mm transcatheter aortic valve replacement system, touting it as the largest sized TAVR system available in the U.S. The Fridley, Minn.-based company said the system is cleared for use in patients with severe aortic stenosis and who are at high or extreme risk […]
Doc inventor sues St. Jude, Medtronic over heart valve patents
A cardiac physician is taking St. Jude Medical (NYSE:STJ) and Medtronic (NYSE:MDT) to court claiming they copied work from 2 of his patents with their own devices. Dr. Robert Snyder, founder of Snyder Heart Valve, filed suits in the United States Court for the Eastern District of Texas, Sherman Division, claiming that both companies used technology […]
FDA updates warning on SynCardia drivers
SynCardia Systems today released an update on issues with its Temporary Total Artificial Heart’s Companion 2 driver system and released information on neurological adverse event issues with its pneumatic Freedom driver system. A post-approval study in June 2015 indicated a higher mortality rate for a subgroup of patients using SynCardia’s TAH-t C2 driver system compared with […]
Medtronic recalls Heartware HVADs over driveline contamination issues
The FDA today released a recall notice for Medtronic (NYSE:MDT) subsidiary HeartWare International‘s Heartware Ventricular Assist Device over issues with driveline connector tubes of select units which may cause the pump to stop. The federal watchdog labeled the recall as Class 1, indicating “a reasonable probability that use of these products will cause serious adverse health consequences or […]