Cardio

FDA clearance of Medtronic’s Affinity Pixie® Oxygenation system provides Perfusionists with options for a broader range of patients. The system was CE marked in May 2010 so won’t be new to Europeans.

Micell Technologies, Inc. has announced positive data from two clinical studies of its investigational MiStent® Sirolimus Eluting Absorbable Polymer Coronary Stent System (MiStent SES™), a thin-strut drug-eluting stent distinguished by a rapid-absorbing drug/polymer coating designed to control drug release.

Results from St.Jude’s RESPECT PFO trial presented at TCT 2012 show that the primary analysis was not statistically significant but trended towards superiority, while additional analyses demonstrated superiority.

New data, presented at TCT 2012 from the ADVANCE registry, confirms that mortality rates with transcatheter aortic-valve implantation (TAVI) using Medtronic’s CoreValve have dropped steadily since the devices’ earliest clinical trials.

CardioKinetix’s Parachute ventricular partitioning device has had its CE mark extended to include a full range of sizes, opening up percutaneous ventricular restoration therapy to a wider range of patient anatomies.

The theory is based on sound principles. Insert a coronary stent that is able to expand to adapt to changing vessel size and it will be more effective as the vessel dilates and clot dissolves. Now FDA’s approval of an IDE study will allow Stentys to back its claims.

Five-year results from the LEADERS trial, showed improved long-term clinical outcomes for BioMatrix Flex™, Biosensors’ Biolimus A9™-eluting stent system with a biodegradable polymer coating, compared to J&J’s Cypher® Select™, sirolimus-eluter coated with a durable polymer.

New Data Presented at the 24th Annual Transcatheter Cardiovascular Therapeutics Scientific Symposium Show Sustained Blood Pressure Reduction and Safety with Symplicity™ Renal Denervation System in Patients with Treatment-Resistant Hypertension

Edwards Lifesciences reported third quarter results showing global THV Sales grew 50% with EPS up 35 Percent (53 Percent Excluding Special Items). Fourth quarter sales and earnings guidance trimmed and still heavily reliant on Sapien uptake.

In theory combining wire, balloon and coronary stent into a single delivery system will make life easier and quicker for physicians. The U.S.FDA has now sanctioned an investigational study into Svelte’s new IDS which the company claims ticks those particular boxes.

Such is the buzz around transcatheter heart valve replacement that the FDA has seen fit to issue a press release giving its own interpretation of the approval issued to Edwards’ Sapien valve for patients considered high risk for conventional surgery.

Edwards Lifesciences’ long wait for an extended indication for its Sapien Valve is over with the news that FDA has rubber stamped the guidance from its summer expert circulatory panel meeting.

Treatment of Atrial Septal Defects remains newsworthy and competitive as the main players vie for the upper hand. Now, a week before TCT 2012, Gore announces the first patient in its U.S study to have received its new septal occluder.

Loma Vista Medical says its World first ultra-precise balloon is specifically designed to prevent balloon ruptures in TAVI and BAV procedures. Catch it at TCT 2012.

It’s not all doom and gloom for St.Jude, but its hard to find much good news from the revenue lines. AF is the shining star from the sales perspective, and the bottom line has been tarnished by inclusion of costs associated with reorganisation

UK regulatory agency the MHRA has issued a device alert relating to the MicroPace 4580 from Pace Medical, distributed in the UK by APC Cardiovascular. Full details of the alert and required actions can be found here.