Clinical Studies/Trials

Belgian researchers have stirred up a hornets nest with their assertion that evidence for TAVI means its use should be more limited than is the case, and furthermore that we’re still not getting the whole picture.

First randomized controlled study comparing Benvenue’s Kiva VCF treatment system to Medtronic’s Kyphon Balloon Kyphoplasty concludes ahead of schedule – Pre-defined criteria for early Stopping of subject enrollment met.

In the fight against AIDS, male circumcision is a key contributory factor in preventing female-male transmission. A simple device could offer the best chance of attaining targeted circumcision rates in Africa, mostly because it is simple and non surgical.

It’s was SNIS 2012 last week, the annual meeting of the Society for Neurointerventional Surgery. Neuro device company Nfocus Neuromedical, Inc., used the occasion to announce positive data from an ongoing clinical study of the company’s Luna Aneurysm Embolization System (AES).

Vascular robotics company Corindus Vascular Robotics, has announced FDA 510(k) clearance has been granted for its CorPath 200 System to be used in percutaneous coronary interventions (PCI).

St.Jude’s CEO Dan Sparks used the word “favorable”(sic) to describe the outcome from its giant study into whether closure of a patent foramen ovale using the company’s Amplatzer device has a positive impact on incidence of cryptogenic stroke. Some commentators are suggesting he should have kept schtum until the clinical results are published later in the year.

SpineGuard, the company with the stated mission of making spinal surgery safer, has announced that data accepted by Spine and published ahead-of-print online demonstrates that the Company’s PediGuard® device reduces spine surgeons’ radiation exposure from fluoroscopy by 30% while maintaining a 97.5% accurate placement of pedicle screws during lumbar spine fusion.

Biotronik has announced that the first cardiac resynchronisation therapy device (CRT-D) patient has been enrolled in its so-called EuroEco Trial—the European Health Economic Trial on Home Monitoring in implantable cardioverter-defibrillator (ICD) and CRT-D patients.

US researchers have found that the irregular heart rhythms of atrial fibrillation are caused by small electrical localised sources or “hotspots” inside the heart called focal impulses or rotors. Now they can map these rotors and ablate them with a degree of accuracy which seems to render results which are twice as good as previously achieved.

Expanding Orthopedics’ innovative pedicle screw system saw its 12 month clinical study published as an e-poster at SRS last weekend. Despite not being a comparative study, results from the ten patients suggest the device may offer earlier pain reduction and improved clinical outcomes compared with standard pedicle screws.

There’s no stopping Covidien’ s neurovascular clot retrieval device, which the company has announced can now add Brazil to Europe and USA as territories wher eit is approved for sale.

Retinal prosthesis pioneer company Second Sight Medical Products Inc., has announced that a U.S. FDA Ophthalmic Devices Advisory Panel will take place on September 28th to review the company’s Humanitarian Device Exemption (HDE) market approval application for its Argus II Retinal Prosthesis System (Argus II prosthesis).

Canadian company CellAegis Devices, Inc., has announced that it has received a CE Mark for its autoRIC™ Device, which the company says for the first time allows simple, consistent, reliable and cost-effective automation of remote ischemic conditioning at the point of care.

St. Jude Medical, Inc., has gone public with initial findings from its Riata Lead Evaluation Study. The study’s phase-one results found that externalised conductors occurred in 9.3 percent of the smaller-diameter Riata ST 7F leads in the study, and in 24 percent of the larger-diameter Riata 8F leads.

Israeli company BioControl Medical has announced U.S. FDA approval to begin the second phase of INOVATE-HF (INcrease Of VAgal TonE in Heart Failure), a global, multi-centre, investigational device exemption (IDE) clinical study of the company’s CardioFit® system for heart failure.

In one of life’s pleasing little coincidences a newly published meta-review of wound care studies has, among its conclusions, established that topical honey reduces wound healing time when compared to film or gauze-based dressings for burns. Derma Sciences, Inc., with perfect timing has announced the CE Marking for its patented MEDIHONEY® HCS (hydrogel colloidal sheet) dressings, containing (you’ve guessed it), honey.