Clinical Studies/Trials

Medtronic gets a little closer to market (in USA) with the announcement that CoreValve’s extreme risk group enrollment is now complete.

Abstract Yet again the CE vs FDA debate is brought into sharp relief with the news that Cohera Medical has … continue reading “FDA Allows CE Marked Glue In On “Investigational Device” Basis”

Californian Stapler Company Cardica has suspended enrollment in its European clinical trial of the MicroCutter XPRESS 30 due to a small subset of deployments where the XPRESS 30 did not perform satisfactorily in thicker tissue.

Results from the St Jude sponsored ASSERT study has found that pacemaker patients who have no history of atrial tachycardia (AT) or AF, but do have device-detected arrhythmias, are approximately 2.5 times more likely to have a stroke than patients who do not have device-detected arrhythmias.

Results from “high-surgical-risk” study arm of MitraClip EVEREST II trial suggest the device does provide limited reduction in mitral regurgitation in patients for whom surgery is not an option.

Sphincter specialist Torax Medical Inc. has taken a significant step towards FDA approval for its Linx device, designed for treatment of Gastro-Oesophageal-Reflux Disease by gaining the unanimous support of FDA’s 9 member advisory panel.

C. R. Bard, Inc’s acquisition of Lutonix, Inc will position it well to be the first company to gain FDA clearance for a drug coated PTA balloon in what is estimated could be a $1Bn market.

Dutch Haemostasis and Regenerative Medicine company ProFibrix B.V., has announced that its U.S. multicenter Phase II clinical trial with Fibrocaps in spinal, peripheral vascular and general surgery resulted in a highly statistically significant reduction in mean time to haemostasis and incidence of haemostasis at 3, 5 and 10 minutes, as compared to active control.

St. Jude Medical, Inc. has announced that it has met a stopping rule in its RESPECT clinical trial and is closing patient enrollment. The company expects to present its findings during 2012.

First large-scale pacemaker study shows significant reduction in hospitalisations for atrial arrhythmias and related stroke with BIOTRONIK Home Monitoring®

AngioDynamics has completed patient enrollment in its European prospective NanoKnife® System trial for the treatment of locally advanced unresectable pancreatic cancer.

Exactech Inc., has announced the initiation of a prospective, randomized, multi-center, clinical trial to evaluate the safety and effectiveness of a new cartilage repair technology.

St. Jude Medical, Inc. has announced the first implant of its Portico^™ transcatheter aortic valve implant (TAVI) in a European clinical trial to support CE Mark approval.

Boston researchers have found that less than 10% of retrievable IVC filters were removed from patients, despite the fact that the indication for the filter placement was no longer present at discharge.

Baxter Healthcare is providing over £200,000 of funding to two UK studies with the goal of establishing an improved evidence base for home dialysis treatment.

Abbott today announced the initiation of ABSORB II, the first randomized, controlled, multi-center clinical trial to evaluate the safety, efficacy and performance of the Absorb™ bioresorbable vascular scaffold (BVS) compared to the company’s XIENCE PRIME™ Everolimus Eluting Coronary Stent System.