Medtronic is ceasing sales of its HeartWare Ventricular Assist Device (HVAD) system and asking doctors to switch to an alternative means of durable mechanical circulatory support. The decision comes after a number of recalls, including a November 2020 recall of the HVAD’s pump implant kit because the medical device may fail to initially start, restart, or have a delay in restarting after the pump stops.
Abbott Laboratories, which inherited through acquisition Thoratec’s LVAD, has indicated it has the capacity and supply to support growing demand for mechanical circulatory support (MCS) devices with its HeartMate 3 device.
Medtronic reported that it is developing a support program for patients who have had an HVAD implanted and for caregivers and health care professionals who participate in their care.
iRhythm Technologies’s president and CEO Mike Coyle has announced he is stepping down for personal reasons. Douglas Devine, the company’s Chief Financial Officer, has assumed the role of interim CEO while a search for a permanent CEO is conducted. Coyle had just taken the position in January after Kevin King retired.
iRhythm markets the wearable Zio XT technology for monitoring heart rate.
LivaNova has completed the initial close of divesting its heart valve business to Gyrus Capital, an investment firm, for $73 million. The portfolio includes Perceval, a sutureless aortic valve, and Memo 4D, a semi-rigid mitral annuloplasty ring.
About 850 employees will shift to CORCYM, an independent company recently launched and owned by entities funded and controlled by Gyrus to manage the global heart valve business.
Abiomed is acquiring preCARDIA, a company that has developed a catheter-based system designed to rapidly treat ADHF-related volume overload by reducing cardiac filling pressures and promoting decongestion to improve overall cardiac and renal function. The system includes a superior vena cava (SVC) balloon that delivers programmed intermittent occlusion of the SVC.
And in case you missed our last Medtech in a Minute report...
The U.S. International Trade Commission voted to investigate a claim made in April that was filed by AliveCor regarding the Apple Watch. AliveCor says it wants to block the importation of all the Apple Watches in the United States, and claims that the tech giant is infringing on three counts of ECG patents.
Boston Scientific is recalling the Vici SDS and RDS venous stent system due to concerns that stents may migrate from where they are initially implanted. FDA said there have been 17 complaints and reported injuries related to this medical device recall, but no reported deaths.
Emboline, a company that has developed an embolic protection device for transcatheter procedures, raised $55 million in a series D financing round. PolyVascular won a $2 million Small Business Innovation Research grant to support the further development of polymeric transcatheter valve, which is designed to advance options for children in need of pulmonary valve replacement. iRhythm Technologies’ wearable cardiac monitor is evolving with the help of two new FDA clearances. The company’s Zio Patch is now boasting an improved design and updated artificial intelligence.