Cardiovascular

The London-based company has filed a PMA supplement to FDA for the device and it is waiting for review.

FDA approved Edwards Lifesciences' Konect Resilia aortic valved conduit, the first pre-assembled solution for Bentall procedures.

The Woodlands, TX-based company received FDA approval for the Excor Pediatric Ventricular Assist Device in June of 2017.

CVRx's BeAT-HF study represents a major turning point in heart failure therapy and ushers in a new era for breakthrough medical devices.

The Baltimore, MD-based company will use the proceeds to help develop its device for precision transseptal access to the left atrium during structural heart and catheter ablation procedures.

The Santa Clara, CA-based company said the study design would allow an initial analysis of safety and clinical efficacy for PMA submission after the first 250 patients have reached six months of follow-up, and then a second analysis after the...

LeMaitre Vascular acquired Artegraft for $90 million, deepening its core vascular surgery focus.

The Dublin-based company said it has received CE mark for an expanded indication of its Evolut Transcatheter Aortic Valve Implantation system to treat patients with severe native aortic stenosis who are at a low risk of surgical mortality.

Earlier this year the fate of Surmodics' SurVeil CE mark submission was unclear as European regulators temporarily halted review of new paclitaxel devices. The tide has apparently turned, however, because the drug-coated balloon is now CE marked.

The proposed merger comes at a time when many companies have backed away from deals because of the COVID-19 pandemic.