Clinical Trials

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

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.

Interventional Pulmonology company Pulmonx, has announced that the U.S. FDA has approved its request for an Investigational Device Exemption (IDE) to commence a multi-centre pivotal clinical trial which the company hopes will support a subsequent premarket approval application (PMA) for the Zephyr® Endobronchial Valve (EBV).

Medtronic, Inc. is announcing twin milestones for its CoreValve® clinical program on the long road to U.S. approval. First, it completed enrollment in its study of high risk patients in its U.S. Pivotal Trial, and then FDA gave it the nod to start a global trial in intermediate patients.

In a survey of triallists, 100% of respondents said that Navigator™ enhanced patient care. All said they would continue to use the cardiovascular monitoring and clinical decision-making system if made available.

Twenty eight point reduction of systolic blood pressure after one month remained stable at three months using EnligHTN renal denervation system according to ESC hotline session data.

Renal Denervation is probably the biggest buzzphrase in new therapies right now, given the size of the problem it purports to address. Medtronic has seen more promising data published at ESC, suggesting patients treated with its Symplicity™ system benefit from sustained and meaningful BP reduction at 18 months

GI Dynamics, Inc. has announced that it has received conditional approval from the U.S. FDA to commence what it’s calling a pivotal clinical trial of the EndoBarrier® for the treatment of patients who have uncontrolled type 2 diabetes and are obese.

First randomized controlled study comparing Benvenue’s Kiva VCF treatment system to Medtronic’s Kyphon Balloon Kyphoplasty concludes ahead of schedule – Pre-defined criteria for early Stopping of subject enrollment met.

Initial findings from new study suggest successful delivery of PICSO® catheter and administration of PICSO® treatment designed to improve myocardial perfusion following primary PCI is sustained for the 90-minute study goal in first-three STEMI patients.

MicroVention, Inc., has announced that enrollment has begun in the Hydrogel Endovascular Aneurysm Treatment (HEAT) clinical trial, a prospective randomised study of the use of coiling technologies to treat intracranial aneurysms.

Neurological protection against emboli following TAVI is highly desirable, so Claret Medical’s early clinical experience in which over 50% of filter deployments resulted in capture of debris is reason for optimism.

CardioKinetix Inc claims its PARACHUTE III Clinical Trial will evaluate benefits of this new therapy in a real-world setting as it commences enrollment with cases in Germany.

The wonders of effective PR. Either that or RhinoChill® is taking off all on its own merits as this innovative portable brain cooling system receives coverage in all the right places. The concept of brain cooling for heart attack patients, taken right to the front line.

More positive signs for Medtronic’s Renal Denervation System as clinical trial results suggest sustained and significant blood pressure reduction.

Single study shows novel hydrogel scaffold results in better wounds. Product gets CE mark. Should it really be that simple?