October 17, 2008 - Berlin Heart Inc. said yesterday that its EXCOR Pediatric ventricular assist device (VAD) has received unconditional approval from the FDA for IDE (investigation device exemption) study.
In 2007, the FDA had granted conditional approval for the prospective IDE study to begin initially at 10 centers with 10 patients, while the company addressed some questions the FDA had found after reviewing the study design.

October 16, 2008 - Lumen Biomedical Inc. said that Principal Investigator Subbarao V. Myla, M.D., presented the results from the EPIC clinical trial — “Evaluating the Use of the FiberNet Embolic Protection System in Carotid Artery Stenting” — at TCT 2008.

From March 2007 to May 2008, the multicenter, single-arm EPIC clinical trial evaluated the FiberNet Embolic Protection System during carotid artery stenting of 237 high surgical risk patients with a critical carotid artery stenosis. The EPIC trial was an FDA IDE clinical study sponsored by Lumen Biomedical Inc.

October 16, 2008 - The one-year follow-up of the FAME study (FFR vs. angiography for multivessel evaluation) was presented at TCT 2008 and confirms the beneficial clinical and economic impact of FFR when used routinely to guide treatments of multi-vessel disease.

October 16, 2008 - At TCT 2008, Volcano Corp. launched its new PrimeWire Pressure Guide Wire, and the s5-FFR Option for its existing installed base of s5 and s5i imaging consoles in the U.S.

The FDA has given GE Healthcare clearance to market the Vivid i with Intracardiac echo (ICE), a system designed to provide high performance ultrasound in a space saving design.

The GE Innova cardiovascular X-ray system will soon be aided by the new Innova Dose, Innova 3D and Innova with Stent Technologies features. GE’s Innova Dose package aims to deliver superb image quality and custom dose management.

October 15, 2008 – Neovasc Inc., a new specialty vascular device company comprised of the former Medical Ventures Corp., Neovasc Medical Ltd. and B-Balloon Ltd., featured its Metricath intravascular measurement device at TCT 2008.

Metricath is an arterial and in-stent measurement system that provides precise diameter and cross-sectional area measurements to aid in stent size selection and optimization.

For more information: www.neovasc.com

October 15, 2008 - Cardiogenesis Corp. sponsored an educational symposium entitled "New Horizons in Cardiac Regenerative Medicine: Advancements in Revascularization & Stem Cell Therapy," this week in conjunction with the TCT meeting in Washington, D.C.

October 15, 2008 - Advanced Circulatory Systems Inc. announced this week it has received an additional $1.5 million in funding from the National Institutes of Health (NIH) to continue a study testing two devices used in combination on those who experience cardiac arrest outside a hospital, where the national average for survival is only one in 20.

October 15, 2008 – TeraMedica reported that it won the Frost & Sullivan (F&S) 2008 Customer Value Enhancement Award in the North American Imaging Informatics Markets.

TeraMedica’s portfolio includes product solutions such as Evercore and Univision, which F&S said allow consolidating the multitude of patient data and digital healthcare information under one umbrella and servicing EMR, EHR and RHIO domains with technology such as a service-oriented architecture (SOA) and health information exchanges (HIE).

Subscribe to
© Copyright Wainscot Media. All Rights Reserved.
Subscribe Now