Clinical Studies/Trials

Optical Biopsies captured with Mauna Kea Technologies’ new AQ-Flex™ 19 Miniprobe were deemed easy to interpret with short learning curve for both novice and expert endoscopists according to data presented at Digestive Disease Week 2013

It’s Digestive Disease Week(DDW) in Orlando’s Orange County Convention Center. At the event, PillCam capsule endoscopy pioneer Given Imaging Ltd, has … continue reading “PillCam Starting To Look Like A Diagnostic Option Say Studies”

Stent maker Biosensors,  tells us that new registry data presented this week at EuroPCR 2013 has confirmed that the BioMatrix™ … continue reading “Could New BioMatrix™ DES 5000 Patient Registry Data Result In Shorter DAPT Course?”

This week’s EuroPCR event saw the publication of a study in which patients were treated with the Direct Flow Medical® Transcatheter Aortic Valve System. The DISCOVER Trial full 30-day outcomes suggested minimal post-procedural aortic regurgitation and adverse events.

Results of Randomized JACK-EPC Trial Published in Minerva Cardioangiologica suggest that the antibody coating on OrbusNeich’s Genous stent may be doing its job and attracting endothelial progenitor cells, thereby accelerating stent “healing”.

Embolic protection stent developer, InspireMD, Inc. has announced a robust schedule of educational events and data presentations at next week’s EuroPCR (May 21-24 Paris), culminating in the first presentation of 6-month results from the MASTER (MGuardfor Acute STElevation Reperfusion) trial of the Company’s MGuard™ Embolic Protection Stent

Direct Flow Medical Inc. has received FDA approval for an Investigational Device Exemption (IDE) to begin the SALUS feasibility trial of its novel transcatheter aortic valve system. We’ll be watching to see whether this study replicates EU study results showing a reduction in valve regurgitation.

Elixir Medical Corporation has received CE Mark approval for its DESolve® Novolimus Eluting Bioresorbable Coronary Scaffold System. The scaffold is designed to degrade in about one year returning the patients’ coronary vessel ultimately to its normal de novo state.

CircuLite®, Inc. has received approval from the Federal Agency for Medicines and Health Products in Belgium to commence the CE Mark trial of its SYNERGY® IC Circulatory Support System, the first mechanical support system that does not require major surgery.

St.Jude’s says its new EnligHTN system offers simultaneous ablations with an intuitive touch screen generator, potentially enabling faster procedure times for the treatment of hypertension. A new study aims to back the claims.

St.Jude Medical Inc has issued a press release, telling us that Population Health Research Institute analysis continues to demonstrate strong safety and reliability of Optim-insulated leads. The data was presented at Heart Rhythm 2013 last week.

A low-risk patient cohort has now seen enrollment completed in the PROACT study. When data is complete this study should establish whether reduction in anticoagulant drug therapy is feasible in this patient group, due to the design and material of the On-X valve. The announcement was made at last week’s American Association for Thoracic Surgery annual meeting.

A first-in-human clinical trial using Boston Scientific’s IntellaTip MiFi™ XP Ablation Catheter for the treatment of type 1 atrial flutter has been completed in Australia.

A second of the companies heading down the FDA’s new Early Feasibility Pilot Study route is Texan outfit BiO2 with its clever anti-embolic Angel Catheter. Strikingly, as the study gets the FDA’s nod to commence, the device is already on the market in Europe.

St.Jude’s MultiPoint Pacing study is designed to show improved effectiveness for patients when pacing multiple locations of the heart. Enrollment has begun in the 50 U.S. centers expected to recruit 500 patients.

The first implants of a novel aortic stent graft for use where aneurysms include sidebranches, have been performed under a new FDA early feasibility pilot program, designed to encourage more early-stage clinical research on new medical devices.