Clinical Trials

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.

GI Dynamics, Inc. is to transition its EndoBarrier® Gastrointestinal Liner from clinical research status to commercial availability in Netherlands.

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.

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.

MedCity News has reported on AtriCure’s quest to gain approval for use of the device in a minimally invasive fashion in stand-alone procedures to close the LAA.

SvelteMedical Systems Announces Treatment of First Patient in the DIRECT Drug-Eluting Stent Study.

Biotronik’s thin strut PRO-Kinetic Energy bare metal stent with passive PROBIO coating showed excellent results in a 1,000 patient all-comers registry.

In a study of 35 families, obese family members of patients undergoing bariatric surgery also showed a statistically significant weight loss.

Results from the COBRA clinical trial presented at TCT2011 show restenosis rate significantly reduced in diabetics when Cryoplasty adopted in SFA Stenting.

Researchers claim Transapical TAVR is “unattractive from a health economic perspective.” compared with femoral approach.

A new study shows no significant differences in the number of deaths or readmittances to hospitals following PCI, whether the patients were discharged the same day or stayed overnight for observation.