The Latest Cardiac and Vascular News
Transaction Highlights: Admedus has sold the distribution rights to its CardioCel® and VascuCel® product range for $A36.2 million (including all earnouts) to LeMaitre Vascular Inc. $A22.8M upfront payment plus two instalments of $A1m each after 12 months and 36 months Up to $A11.4M on earn-out payments for a total $A36.2M (at the current $US0.67/$A1 rate), subject to achievement of certain milestones Up to […]
Prospective Study to Evaluate Safety and Performance of Indigo® System and CAT RX Aspiration Catheter ALAMEDA, Calif. – October 10, 2019 – Penumbra, Inc. (NYSE: PEN), a global healthcare company focused on innovative therapies, today announced enrollment of the first patient into the CHEETAH study, a prospective, multi-center U.S. study to […]
DUBLIN, Oct. 09, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) today announced the U.S. Food and Drug Administration (FDA) has classified the company’s voluntary field action initiated in March 2019 related to the 6F Sherpa™ NX Active Coronary Guide Catheter as a Class I recall. The catheter is used during coronary […]
TEWKSBURY, Mass., Oct. 9, 2019 /PRNewswire/ — Corvia Medical, Inc., a privately-held company with a first-in-class structural heart device to treat heart failure, today announced the US Food and Drug Administration (FDA) has granted the company a Breakthrough Device designation for its InterAtrial Shunt Device (IASD) for heart failure. The IASD is […]
VANCOUVER, British Columbia, Oct. 08, 2019 (GLOBE NEWSWIRE) — Novoheart Holdings Inc. (“Novoheart” or the “Company”) (TSXV: NVH; FWB: 3NH) announces that it has granted incentive stock options to purchase an aggregate of 1,150,000 common shares of the Company (the “Options”) to non-executive directors of the Company. Option Grants The Options have […]
Malmö, 9 October 2019 The subscription period in Acarix’ rights issue commence today The board of directors of Acarix AB (“Acarix” or the “Company”) resolved on 25 September 2019, pursuant to the authorization granted by the extra general meeting on 16 August 2019, to carry out a new share issue […]
Introduction of Orbital Atherectomy Expands Treatment Options for Patients with Peripheral Artery Disease ST. PAUL, Minn.–(BUSINESS WIRE)–Cardiovascular Systems, Inc. (CSI®) (NASDAQ: CSII), a medical device company developing and commercializing innovative interventional treatment systems for patients with peripheral and coronary artery disease, announced today that the first patient in the United […]
News Follows Medtronic Receiving FDA Breakthrough Device Designation for its Valiant Navion™ LSA Branch Thoracic Stent Graft System DUBLIN, Oct. 08, 2019 (GLOBE NEWSWIRE) — Medtronic plc (NYSE:MDT) today announced it has received Breakthrough Device designation from the U.S. Food and Drug Administration (FDA) for its Valiant® TAAA Stent Graft System […]
TORUS-2 marks second Investigational Device Exemption approved for company in less than two years. MILPITAS, Calif.–(BUSINESS WIRE)–PQ Bypass, Inc., a clinical-stage medical device company, today announced it has received full approval of its investigational device exemption (IDE) trial of the company’s TORUS stent graft, a novel stent graft platform designed […]
SAN RAMON, Calif., Oct. 8, 2019 /PRNewswire/ — BioVentrix, Inc. announced the first patient was enrolled and treated in the REVIVE-HF European study, a prospective multi-center, dual-arm randomized controlled study evaluating the treatment of ischemic cardiomyopathy induced heart failure with the Revivent TCTM System compared to Guideline-Directed Medical Therapy (GDMT) or drug treatment. The patient […]
