Clinical Studies/Trials

CardioFocus, Inc.is drawing our attention to a study in the journal Heart Rhythm, demonstrating 98% acute success and durable pulmonary vein (PV) isolation rates achievable with a single, visually-guided HeartLight EAS ablation procedure.

Data released on six month randomised, multi-centre trial of EndoBarrier® versus control in obese, type 2 diabetic subjects suggests the device, as well as being well tolerated does result in statistically significant reduced blood sugar levels and weight loss.

InspireMD has announced that its president and co-founder Asher Holzer, Ph.D., is retiring as president of the Company.

Acellular dermal matrices provide good outcomes, with low complication rates, when used for breast reconstruction after mastectomy for breast cancer, according to a study in the June issue of Plastic and Reconstructive Surgery®, the official medical journal of the American Society of Plastic Surgeons (ASPS).

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.

Edwards Lifesciences Corporation has received conditional IDE approval from the US FDA to initiate a clinical trial to study its GLX next-generation tissue treatment platform applied to a surgical bovine pericardial heart valve. It seems EU regulatory barriers are somewhat lower, the product having been CE marked in May.

InspireMD has announced that it has completed enrollment in the MASTER (MGuard™ for Acute ST Elevation Reperfusion) trial and is on track to release preliminary top line results in the third quarter of 2012.

Baxano Inc., has announced it has completed enrollment in its post-market clinical performance evaluation of the company’s flagship surgical system for decompressing patients diagnosed with moderate to severe lumbar spinal stenosis.

Last week saw the holding of the European Stroke Conference in Lisbon, Portugal, at which event Stryker announced the results of the TREVO 2 clinical trial comparing its Trevo® clot removal device with its current Merci® product.

According to study results presented at the American Association of Clinical Endocrinologists (AACE) 21st Annual Scientific and Clinical Congress in Philadelphia, Medtronic’s Resolute® drug-eluting stent (DES) from Medtronic, Inc. yields strong performance in coronary artery disease (CAD) patients both with and without diabetes through two years of follow-up.

Boston Scientific Corporation took the opportunity presented by EuroPCR to announce “excellent” two-year results from the PLATINUM Small Vessel study.

Biotronik’s press department was in overdrive at EuroPCR last week, announcing that twelve-month results from the BIOSOLVE-I study with the DRug Eluting Absorbable Metal Scaffold (DREAMS) demonstrate safety and confirm vessel vasomotion.

Another press release from Biotronik following last week’s EuroPCR meeting in Paris talks of six-month results from the DELUX registry demonstrating excellent safety and efficacy results for the Pantera Lux Paclitaxel Releasing Balloon.

Results presented at EuroPCR demonstrate minimally invasive “Parachute” device from CardioKinetix could transform treatment options for patients as two year results suggest significant improvement in condition.

The big surprise in this new study, published at AANA this week, is that it’s taken so long for researchers to put a figure on the cost savings to be had in saline consumption alone by using an inflow/outflow computer controlled arthroscopic pump rather than inflow only. Maybe its just a sign of the times that it’s even become an issue.

Not satisfied with just drug elution as a means of reducing neointimal hyperplasia, OrbusNeich has built in an Endothelial Progenitor Cell capture coating which appears in this blinded study to improve neointimal appearance at 9 months.