Clinical Studies

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.

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.

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.

Boston Scientific has enrolled the first patient in the REPRISE II clinical trial to evaluate the safety and performance of the Lotus™ Valve System and the results are expected to be used to support CE mark and other international regulatory approvals.

Study confirms effectiveness of directional Atherectomy with SilverHawk ™ and TurboHawk ™ Devices as a frontline therapy when treating PAD

Data published today in the Headache Society journal Cephalagia shows significant reductions in pain, headache days and migraine-related disability when Peripheral Nerve Stimulation therapy is applied.

Sunshine Heart Inc. has announced that it has received conditional approval from the FDA for an Investigational Device Exemption for its flagship C-Pulse extra-aortic, counter-pulsation, heart assist device.

German cardiology company Cardionovum GmbH has trumpeted results from a soon-to-be published preclinical and first-in-man clinical study of its Primus Drug-Coated Balloon (DCB). Clinical study results point to high procedural efficacy and no adverse clinical events out to six months.

Hyperbranch possesses its own particular hydrogel which is already sold in Europe as a dural sealant for use following neurosurgery. Now the company has taken a step towards FDA approval with the news that it has completed enrollment in its pivotal IDE study.

It’s an understatement to say that mitral valve replacement is a tricky business, so it’s unsurprising to see Neovasc trumpeting early successes in an about-to-be published preclinical study.

Registry data published in Neurosurgery suggests Codman’s Enterprise stent-assisted coil embolization system is an effective tool in the occlusion of neurovascular aneurysms with positive outcomes at 21 months.

Medtronic, Inc. has announced findings from a health-economic analysis published online before print in The Journal of the American College of Cardiology that suggest the company’s Symplicity™ renal denervation system is a cost-effective treatment strategy for patients with treatment-resistant hypertension.