Cordis Corporation announced the presentation of the two-year STROLL study results at the Abstracts and Late Breaking Clinical Trials session at ISET 2013.
Biotronik announced that the U.S. Food and Drug Administration (FDA) has approved, with conditions, the ProMRI clinical trial via an Investigational Device Exemption. Biotronik is sponsoring the trial (NCT01761162) and has already initiated U.S. site recruitment. The ProMRI clinical trial is designed to recruit 245 subjects implanted with one of Biotronik’s cardiac devices that include ProMRI technology at 30 U.S. investigational centers.
GNAX Health announced the availability of GNAX SDEX Secure digital imaging and communications in medicine (DICOM) Exchange, allowing hospitals, ACOs and HIEs the ability to transfer medical images securely. The announcement was made by Jeff Hinkle, CEO, GNAX, at the Radiological Society of North America's 98th Scientific Assembly and Annual Meeting in Chicago, Ill.
January 21, 2013 — ECRI Institute, a nonprofit organization that researches the best approaches to improving patient care, recently evaluated evidence behind the use of the only transcatheter heart valve approved for marketing in the United States and Europe in transcatheter aortic valve implantation (TAVI).
January 21, 2013 — Avreo announced it has formed a partnership with VidiStar LLC, a provider of cardiology medical imaging and reporting solutions using the latest technological standards for image interpretation, clinical analysis and medical reporting.
The first patient has been treated in the Boston Scientific Corporation ZERO AF clinical trial to evaluate the safety and effectiveness of the Blazer open-irrigated temperature ablation Catheter in patients with symptomatic, drug refractory paroxysmal atrial fibrillation. This international, multi-center study will include up to 33 sites in the United States, Europe and Asia-Pacific, and as many as 472 patients. The results of the ZERO AF trial are expected to be used to support a U.S. Food and Drug Administration (FDA) regulatory submission for a paroxysmal atrial fibrillation indication.
