Clinical Studies/Trials

Transcatheter heart valves hit our news pages seemingly every week. Today its the turn of Medtronic with the news that its Engager valve, optimised for transapical delivery, has gained CE mark approval, based on solid looking numbers from its pivotal multi-center study.

Covidien has completed patient enrollment in its iliac stent clinical study series. The series is composed of two prospective, multinational, multicenter studies – VISIBILITY Iliac and DURABILITY Iliac.

Medtronic’s new Transcatheter pulmonary valve study, approved by the FDA, represents the first time this new draft guidance has been employed. The result should be a better product, earlier to market, if the klegislation is doing its job.

Allergan’s Natrelle® breast implant line now extends to a newly FDA approved shaped silicone gel option. The implant is already available in Europe and has proven popular, not least because of its anatomical shape.

Ventrix, Inc. announced today that its VentriGel™ cardiac repair scaffold safely and effectively mitigated left ventricular remodeling and improved cardiac function in pigs after myocardial infarction. The findings, made during pre-clinical studies, have been published in the journal Science Translational Medicine.

Lombard Medical Technologies PLC has announced that its Aorfix™ endovascular stent graft has been approved for commercial sale in the U.S. by the FDA. Aorfix™ is now the only endovascular stent graft licensed in the U.S. for use in more challenging cases with neck angulations greater than 60 degrees.

“Super therapy” renal denervation may favourably impact major cardiac events and a new study hopes to demonstrate to what extent. We’ll be fascinated to see the results and are betting the house on the fact that there is a positive effect.

Findings from a newly published study suggest that as well as improving patient care, remote monitoring using Biotronik’s proprietary system also takes pressure of the clinical routine.

According to a new report , published in “Value in Health”, delaying Total Hip Replacement surgery in people with osteoarthritis as a way to cut costs is ineffective and denies patients the benefits of an active and healthy life.

Presentation of neurological data confirms patients in the device group had fewer, smaller strokes that were less likely to originate from blood clots passing through the PFO

Interventional Neurology’s on-off relationship with mechanical thrombectomy might be back on with this solid looking data from Covidien’s STAR study into the safety and efficacy of the Solitaire FR device in AIS patients.

Results published in the Journal of Clinical Endocrinology & Metabolism show powerful impact of EndoBarrier therapy in people with Type 2 Diabetes and Lower Body Mass Index.

St. Jude Medical, Inc. has announced the first patient implant of its 25 mm Portico™ Transcatheter Aortic Heart Valve using the Transfemoral Delivery System in its ongoing European trial.

IDEV Technologies is trumpeting results from a newly published study which suggest that its Supera stent could be a treatment option for patients that would not have been offered a standard nitinol stent for popliteal artery disease.

Contact-force sensing cardiac ablation for arrhythmia treatment has taken a step forward with the announcement by Endosense that its newest iteration device has been used in a US patient for the first time. The device has been on general release in Europe since last June.

New Jersey based Svelte® Medical Systems has announced treatment of a first patient in the DIRECT II study into its drug-eluting stent. The company claims to have the lowest profile drug eluting stent on the market, benefits of which it hopes this new study will demonstrate.