Medtronic (NYSE:MDT) said today it launched a pivotal trial of its Intrepid transcatheter mitral valve replacement system after winning FDA investigational device exemption for the device. The 1st patient in the trial was enrolled at Milwaukee’s Aurora St. Luke’s Medical Center, the Fridley, Minn.-based company said. The Apollo trial is slated to enroll up to 1,200 […]
Cardiac Implants
The 11 most innovative medical devices of 2017
The nominees for the best medical technology of 2017 were recently announced for the 11th Annual Prix Galien USA Awards. The Galien Foundation, the host of the awards, hands out the the Prix Galien Award annually to examples of outstanding biomedical and technology product achievement designed to improve human condition. Before candidates can qualify for […]
Appeals court revives Thoratec shareholders suit
A Ninth Circuit panel this week revived a shareholders suit against Thoratec (NSDQ:THOR), deciding that it was a mistake for a lower court to dismiss the case and that investors had sufficient grounds for claiming that the company misled them. The securities class action suit was brought against Thoratec in January 2014. Investor Bradley Cooper sued the […]
Edwards Lifesciences has ‘key events’ around TAVR this week
Edwards Lifesciences is planning some important TAVR reveals during the PCR London Valves 2017 course that is underway. The Irvine, Calif.–based cardio devices company said yesterday that it plans to introduce the new Sapien 3 Ultra valve during the event, which runs until tomorrow. Edwards officials expect the Sapien 3 Ultra to receive CE Mark […]
How Abbott is making good on investor promises
Abbott (NYSE: ABT) has won FDA approval of MR-compatible ICDs – an indication that it could be making good executing on key priorities it inherited when it acquired St. Jude Medical for $25 billion early this year. The news today “lends incremental credibility to our thesis that ABT can and will have a positive impact on STJ […]
Transcatheter heart valve surgery simulator dev FEops raises $7m
Surgical simulation software developer FEops said today it raised $7.2 million (EU €6 million) in funding to support its HeartGuide transcatheter valve implantation simulation software. The round was led by newly invested Valiance and joined by existing investors Capricorn and PMV, the Gent, Belgium-based company said. FEops’ flagship product is the HeartGuide platform, which use […]
Medtronic launches post-market study of CoreValve Evolut Pro heart valve
Medtronic (NYSE:MDT) said today it launched a post-market clinical study of its CoreValve Evolut Pro valve, looking to evaluate performance out to 5 years for the self-expanding transcather aortic valve implantation system. The multi-center, prospective single-arm study aims to enroll 600 patients across 35 European sites to evaluate the safety of the CoreValve Evolut Pro, including […]
Investors seek class action status in lawsuit over St. Jude implantable defib batteries
Abbott (NYSE:ABT) is facing an investor suit from an Alaskan union-benefits fund over allegations that St. Jude Medical, which it closed its acquisition of in January, failed to notify regulators about defective lithium batteries in its implantable defibrillators. In the lawsuit, plaintiffs allege that St. Jude was informed of the battery defect “as early as 2011”, […]
AtriCure launches AtriClip Pro-V in the US
AtriCure (NSDQ:ATRC) said today it launched its AtriClip Pro-V left atrial appendate exclusion system in the US. The newly launched AtriClip Pro-V is designed to be placed through a minimally-invasive surgery and features an open-ended design and tip-first closure mechanism for easier navigation, the Mason, Ohio.-based company claims. “Development of the AtriClip Pro-V is another step […]
NaviGate touts 1st 52mm transcatheter tricuspid valve procedure
NaviGate Cardiac Structures touted this week that its Gate catheter-guided tricuspid atrioventricular valved stent was implanted six weeks ago into a patient’s transplanted heart. The patient’s transplanted heart was failing due to severe tricuspid valve insufficiency. The successful implantation at the Policlinico of the University of Padua, Italy, is the first European-based patient treated with […]
ESC 2017 Roundup: Biotronik touts lowered mortality for AF patients treated with cath ablation
Biotronik today released results from the Castle-AF study exploring the use of catheter ablation to treat heart failure patients with atrial fibrillation, touting a 38% composite reduction in all-cause mortality and hospitalization for worsening heart failure. The 398-patient, 33-site study compared the results of catheter ablation treatment for AF in heart failure patients using implantable cardioverter […]