The Centers for Medicare and Medicaid Services (CMS) may extend coverage for artificial hearts and ventricular assist devices (VADs). Currently, Medicare covers artificial hearts for beneficiaries enrolled in a CMS-approved clinical study, a status that hasn’t been updated since 2008. Artificial heart-maker SynCardia wrote a letter last year to CMS asking it to extend coverage […]
SynCardia
Medtronic taps Lennon as CIO | Personnel Moves – April 9, 2018
Medtronic (NYSE:MDT) said that it named Sean Lennon as its new chief information officer, set to take effect April 29. The Fridley, Minn.-based medtech giant said that Lennon will take over for Mike Hedges, who is retiring from the position after 19 years with Medtronic, including 10 as CIO. Prior to joining Medtronic, Lennon served as […]
HydroCision names Tranchemontagne as CEO | Personnel Moves – March 12, 2019
HydroCision said early this month that it tapped former Smith & Nephew (NYSE:SNN) exec Alain Tranchemontagne as its new chief executive officer. Prior to joining Boston-based HydroCision, Tranchemontagne held a position as U.S. business commercial development senior VP at Smith & Nephew. Before joining Smith & Nephew, Tranchemontagne also held positions at Covidien in senior marketing roles […]
SynCardia responds to FDA note warning of high rates of stroke, mortality risk with TAH-t C2 Driver
SynCardia Systems this week responded to an FDA notice warning about a higher mortality risk and stroke rate with the company’s Temporary Total Artificial Heart Companion 2 Driver System noted as part of a post-approval study of the device. In its response, the Tucson, Ariz.-based company said that the FDA letter, which warned of risks associated […]
FDA warns of high stroke, mortality risk with SynCardia TAH-t C2 controller
The FDA on Friday released a letter warning of a higher mortality risk and stroke rate than expected for patients receiving treatment from SynCardia Systems’ Temporary Total Artificial Heart Companion 2 Driver System. Data indicating the higher mortality and stroke rate came from a post-approval study conducted by the company itself, the FDA said. The study […]
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 […]
Versa Ventures buys Syncardia out of bankruptcy
SynCardia Systems said today that it was acquired by affiliates of investment firm Versa Capital Management, with current president & CEO Michael Garippa set to keep the corner office. Tuscon-based Syncardia makes an artificial heart system designed to replace the functions of both the left and right ventricles and all 4 heart valves. On August […]
SynCardia denies competitor’s market exit claim
SynCardia Systems isn’t exiting the market quite yet, according to a press release posted today in response to a competitor’s claim. Syncardia makes an artificial heart system designed to replace the functions of both the left and right ventricles and all 4 heart valves. “SynCardia’s machine works quite well. But it’s a very old machine […]
Syncardia files for Chapter 11 bankruptcy
Artificial heart maker SynCardia Systems filed for Chapter 11 bankruptcy last week after pulling an initial public offering last October. Syncardia makes an artificial heart system designed to replace the functions of both the left and right ventricles and all 4 heart valves, with FDA clearance as a bridge-to-transplant device for heart failure patients. The […]
SynCardia pulls $28m IPO
SynCardia Systems yesterday withdrew its plans for an initial public offering that was slated to fetch $27.5 million at the midpoint. “The registrant submits this request for withdrawal as it does not intend to pursue the contemplated public offering at this time,” the Tucson-based artificial heart maker said in an SEC filing. Syncardia had planned to float […]
SynCardia updates on artificial heart recall
SynCardia Systems said today that the Class I recall of the driver for some of its total artificial heart devices was due to a single incident in which a patient briefly lost consciousness but suffered no permanent injury. All affected devices were taken off the market 8 days after SynCardia’s initial warning August 6, the Tucson-based company […]
