This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC's registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.
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...
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.