Clinical Studies/Trials

PARTNER study findings suggest transapical insertion of Edwards Sapien valve could only be economically justified if the valve cost $15k less than it does or if length of stay was reduced. Right now transfemoral insertion looks like an economically justifiable technique though.

Researchers have reported that last week a first patient in the United States was treated in a late-stage clinical trial of the AeriSeal foam sealant System to treat emphysema.

It’s a fairly polarised argument. If you are in the camp that believes explanted ICDs could and should be donated and re-used in low income countries you’ll appreciate this new paper. However there’s also support for the nay sayers’ arguments in the study.

Data demonstrate high procedural success and low paravalvular leak for Medtronic’s new Engager TAVI offering in late-breaking trials session at the European Association for Cardio-Thoracic Surgery annual meeting.

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.

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

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.

German company Cardionovum GmbH has updated us with the news that its distribution network, covering 57 countries, is pressing ahead with the commercialisation of its Primus® paclitaxel-coated balloon based on preclinical and clinical support.

Voiding dysfunction device company Uroplasty Inc. tells us that positive results from a long-term clinical pilot study using an implantable tibial nerve stimulation device will be presented at the Annual Meeting of the International Continence Society.