Shares of Neovasc (NSDQ:NVCN) are up today after the medical device company released study results showing that its Reducer device for treating angina doesn’t worsen heart function and may in fact help. The Vancouver-based company said the 24-patient study of patients treated with Reducer, which is designed to narrow the coronary sinus, showed no significant […]
Cardiac Implants
Conformal Medical launches LAA seal study
Conformal Medical said yesterday that it launched an investigational device exemption trial for a device designed to seal off the heart’s left atrial appendage to help prevent stroke in atrial fibrillation patients. Nashua, N.H.-based Conformal’s device is designed to adapt to the each patient’s individual physiology, to be easier to implant with less imaging and […]
Abiomed touts new Impella study results
New data on Abiomed (NSDQ:ABMD) Impella heart pumps show a 34% increase in survival among nearly 5,000 patients treated with the company’s devices intended to treat cardiogenic shock when combined with best practices, according to a company study. The study of patients treated at 763 U.S. sites between April 1, 2018 and March 28, 2019 showed median […]
Tioga Medical raises $15m to support transcath mitral, tricuspid valve tech
Newly formed Shifamed portfolio company Tioga Medical said today that it closed a $15 million Series A preferred stock financing round to support its transcatheter mitral and tricuspid valve replacement technology. The Campbell, Calif.-based company said that it is developing novel transcatheter valve replacement technology intended to be simpler and less invasive than current mitral and […]
Tricuspid valve repair device maker CroíValve raises $4m
Early stage tricuspid valve repair device developer CroíValve has raised approximately $3.6 million (EU €3.2 million) in an oversubscribed seed financing round, according to a report from the Irish Times. CroíValve is developing a novel percutaneous solution intended to treat tricuspid regurgitation that seals the central gap between the native valve leaflets to prevent regurgitation, […]
CMS touts ‘more flexibility’ in new TAVR coverage requirements
The Centers for Medicare and Medicaid Services have proposed new policy that could expand the use of transcatheter aortic valve replacement procedures, touting that it may provide more flexibility for starting and maintaining TAVR programs. The original National Coverage Determination for TAVR procedures was cleared in 2012, when the technology and associated procedure was still […]
Homeland Security details vulnerabilities in Medtronic ICD, CRT-Ds, CareLink devices
The U.S. Dept. of Homeland Security today released a medical advisory warning of exploits within a number of Medtronic (NYSE:MDT) implanted cardiac devices and associated equipment that could allow an attacker to affect the functionality of the devices or intercept transmitted sensitive data. The vulnerability affects Fridley, Minn.-based Medtronic devices using its Conexus radio frequency […]
ACC 2019 Roundup: Abiomed Impella RP post-market study shows benefit in select patient group
Abiomed (NSDQ:ABMD) today released 18-month post-approval study data from patients treated with its Impella RP, touting a benefit to survival for specifically selected “Recover Right” protocol patients. Results from the study were presented at the American College of Cardiology’s 68th Annual Scientific Sessions in New Orleans, the Danvers, Mass.-based company said. The review follows a release […]
ACC 2019: Abbott touts reduced stroke, bleeding and pump-clotting in HeartMate 3 trial
Abbott (NYSE:ABT) yesterday presented data from a new trial of its HeartMate 3 left ventricular assist device, touting a reduced rate of strokes, pump-related blood clots and bleeding episodes at two years as compared with the previous generation HeartMate II. Data in the trial was presented at the American College of Cardiology’s 68th Annual Scientific Session […]
ACC 2019: Medtronic, Edwards low-risk TAVR trial data could pave way to new indications
Results from trials of both Medtronic‘s (NYSE:MDT) and Edwards Lifesciences‘ (NYSE:EW) transcatheter aortic valve replacement systems exploring their use in low-risk patients indicated that the devices were as safe as open surgery, paving the way for possible new indications for TAVR technology. Data from the trials were presented over the weekend at the American College […]
Abbott wins expanded indications for MitraClip
Updated to include commentary from Abbott The FDA today said that it granted Abbott (NYSE:ABT) a new indication for its MitraClip system, expanding coverage of the device to patients with normal mitral valves with diminished left heart function. The indication expands upon the original approval, which the Chicago-area medical device maker won in 2013, clearing it for […]