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SynCardia

SynCardia picks up patent for total artificial heart

October 31, 2024 By Sean Whooley

SynCardia announced today that it received a second patent expanding the coverage of its fully implantable artificial heart technology. Tucson, Arizona–based SynCardia received the first patent (no. 11,918,797) related to its next-generation Emperor total artificial heart in March. The U.S. Patent and Trademark Office (USPTO) has now issued a second patent (no. 12,121,711 B2) for […]

Filed Under: Cardiac Implants, Cardiovascular, Replacement Heart Valves, Structural Heart Tagged With: SynCardia

CMS considers extending Medicare coverage for heart devices

February 5, 2020 By Nancy Crotti

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 […]

Filed Under: Cardiac Implants, Featured, Medicare Tagged With: Abbott, Centers for Medicare and Medicaid Services (CMS), SynCardia

Medtronic taps Lennon as CIO | Personnel Moves – April 9, 2018

April 9, 2019 By Fink Densford

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 […]

Filed Under: Business/Financial News, Wall Street Beat Tagged With: Allergan, Clearside Biomedical, ICU Medical Inc., iHear Medical, LifeScan Inc., lumenxt, Medtronic, Novartis, OptiScan, oregonbioscienceassociation, Owens and Minor, Shape Memory Therapeutics, SynCardia

HydroCision names Tranchemontagne as CEO | Personnel Moves – March 12, 2019

March 12, 2019 By Fink Densford

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 […]

Filed Under: Business/Financial News Tagged With: Aethlon Medical Inc., camberspine, Humacyte, HydroCision Inc., Invictus Medical, IRRAS, Johnson and Johnson, MediWounds, qureai, Senseonics, Smith & Nephew, SynCardia, V-Wave, Virta Health

SynCardia responds to FDA note warning of high rates of stroke, mortality risk with TAH-t C2 Driver

August 29, 2018 By Fink Densford

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 […]

Filed Under: Cardiovascular, Clinical Trials, Food & Drug Administration (FDA) Tagged With: SynCardia

FDA warns of high stroke, mortality risk with SynCardia TAH-t C2 controller

August 20, 2018 By Fink Densford

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 […]

Filed Under: Cardiovascular, Clinical Trials, Food & Drug Administration (FDA) Tagged With: SynCardia

FDA updates warning on SynCardia drivers

October 26, 2016 By Fink Densford

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 […]

Filed Under: Cardiac Implants, Cardiovascular, Food & Drug Administration (FDA), Recalls Tagged With: SynCardia

Versa Ventures buys Syncardia out of bankruptcy

September 20, 2016 By Fink Densford

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 […]

Filed Under: Cardiovascular, Mergers & Acquisitions, Structural Heart, Wall Street Beat Tagged With: SynCardia, Versa Capital Management

SynCardia denies competitor’s market exit claim

August 16, 2016 By Fink Densford

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 […]

Filed Under: Business/Financial News, Cardiac Implants, Cardiovascular Tagged With: SynCardia

Syncardia files for Chapter 11 bankruptcy

July 5, 2016 By Fink Densford

  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 […]

Filed Under: Business/Financial News, Cardiovascular Tagged With: SynCardia

SynCardia pulls $28m IPO

October 14, 2015 By Brad Perriello

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 […]

Filed Under: Funding Roundup, Initial Public Offering (IPO) Tagged With: Artificial Organs, SynCardia

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