Clinical Studies/Trials

CircuLite®, Inc. has announced 90-day results for the final 26 patients in its CE Mark Trial of the SYNERGY® Circulatory Support System. The results show clinically meaningful and sustained hemodynamic improvements, with a relatively low rate of adverse events when compared with larger support devices.

A newly published study suggests that CABG surgery results in improved survival at five years compared with a matched population of PCI patients, although the gap is narrowed where concomitant diseases exist.

InspireMD, Inc., the developer of the MGuard™ Embolic Protection Stent (EPS), has announced approval with conditions for its US FDA Investigational Device Exemption (IDE) application. This approval allows the company to initiate enrollment in the MASTER II IDE trial.

Patient monitoring device company CAS Medical Systems, Inc., has received U.S. FDA 510(k) clearance for its next-generation FORE-SIGHT ELITE(TM) Absolute Tissue Oximeter, which it claims is more accurate than its predecessor.

A solid set of clinical data underpins FDAs decision to extend Endologix’s FDA approval to include so-called percutaneous endovascular repair (PEVAR) of triple AAAs. Seems the procedure is quicker, safer, less painful and requires fewer transfusions than EVAR.

Cook Medical has launched the VIVO clinical research study to evaluate the safety and effectiveness of the Zilver® Vena™ Venous Self-Expanding Stent in the treatment of symptomatic iliofemoral venous outflow obstruction.

Positive three-month data for Vent-Os chronic sinusitis device have been presented at this week’s Combined Otolaryngology Spring Meeting in Orlando. The device offers an alternative to rapid, high pressure balloon inflation treatment.

The FDA has approved an IDE for InVivo’s biopolymer scaffold, making it the first such treatment to dip its toe in the America patient population. The new study is expected to deliver a Humanitarian Device Exemption, giving it access to market sooner than a PMA.

At last week’s Annual German Cardiac Society meeting Swiss transcatheter valve developer Symetis saw registry data from the Symetis ACURATE TA™ Valve Implantation (SAVI) Registry presented. Low leakage and mortality reported.

Really clever “slide and lock” mechanism features in the design of this bioresorbable drug eluting coronary stent. Reva Medical has now commenced enrollment in the study it hopes will get it to regulatory approval in Europe.

Abiomed gets the ball rolling with news that it has seen a first patient implated with its Impella RP in the U.S. IDE study into the device. Abiomed is seeking FDA approval under Humanitarian Device Exemption rules.

The Misonix BoneScalpel has seen favourable reviews in new clinical paper accepted for publication by “Neurosurgery,”. In the study the device was used to perform safe, tissue-selective bone dissection that encourages en-bloc bone removal and refined osteotomies while sparing elastic soft tissue structures.

Contact-force reportedly has a bearing on the efficacy and safety of catheter ablation for the treatment of cardiac arrhythmias. Now sensing technology company Endosense has seen the results of its EFFICAS I prospective multi-center study published in the April 2013 issue of the American Heart Association journal Circulation: Arrhythmia and Electrophysiology.

London’s Barts Hospital has enrolled its first patients in the ROX Medical CONTROL-HTN international randomized controlled hypertension trial. The study is evaluating the ROX FLOW procedure, which creates a small connection between artery and vein in the upper leg for the treatment of resistant hypertension.

If you’re of a certain vintage, if your bones are osteoporotic and you suffer a hip fracture, you are at risk of suffering one on the other side. In a piece of potentially smart-thinking a Bordeaux company has a minimally invasive device that might protect you against that eventuality.

Sorin’s newly approved RESPOND CRT trial aims to demonstrate clinical benefit of innovative SonR® CRT optimization system in cardiac resynchronization therapy.