Clinical Studies/Trials

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.

TAVI is a great case study in technology adoption, most strikingly pointing to post-market data in the form of registries as a window on real world use of a technique which actually makes for a pretty compelling endorsement of EU regulatory rules.

Clinical study results presented this week are being touted as support for the theory that by inducing a three dimensional component into a mechanical stent, its flow characteristics will mimic the natural geometry of human vessels.

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

Medtronic’s new design multi-electrode radiofrequency renal denervation system builds on experience with the Symplicity™ Renal Denervation System.

Last week the U.S. FDA issued its Pre-market Approval (PMA) for the Globus SECURE®-C Artificial Cervical Disc. Now the agency has issued its consumer information on the product which the company says outperforms anterior cervical discectomy and fusion.

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.

Taken at face value some new data and reporting suggests that a U.S. style PMA might deliver little benefit in terms of patient safety, yet delay innovations from reaching the market by 43 months. We argue it’s more subtle than that.

DiFusion announced today the completion of a series of in vivo and in vitro clinical tests which, the company says, substantiate their claim that CleanFUZE resists surgical infection and promotes bone growth.

Given Imaging Ltd. developer of the Pillcam Colon 2 swallowable camera system for visualisation of the colorectal lining, has submitted compelling trial data to the Japanese authorities showing that 94% of polyps identified using standard colonoscopy were also spotted by its device.

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.

A new study demonstrates the potential for use of Dune Medical’s MarginProbe system in surgical margin assessment during radical prostatectomy procedures.

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.