Clinical Studies/Trials

The Misonix® BoneScalpel Ultrasonic Bone Cutter has cropped up in a clinical paper, so why wouldn’t the manufacturer point us at the comments, especially when they say the device offers a good solution for head and neck surgeons when harvesting bone.

St.Jude will be hoping that a new study of different degrees of hypertension may expand the indication for its EnligHTN renal denervation technology for hypertension to new patient populations.

So, a drug eluting stent which doesn’t rely on a polymer coating to carry the drug. Clever. And now CE marked in the form of BioFreedom from Biosensors International.

Medtronic, Inc. has announced the start of PROMISE, the first ever, large-scale study comparing the effectiveness of its neurostimulation therapy plus optimal medical management to optimal medical management alone in failed back surgery patients.

UK technology company Zilico tells us that its Zedscan electrical impedance probe can improve colposcopic outcomes, while reducing the need for biopsies. A new paper supports that view with improvements in detection and specificity compared with colposcopy alone.

Ruptured abdominal aortic aneurysms (AAAs) repaired using endovascular techniques may save more lives than surgical repair according to a new Irish analysis, which claims that at 30 days, aneurysm-related survival was 70% for patients treated with endovascular aortic repair (EVAR) compared with 33% for patients who underwent open surgical repair.

J&J’s Cordis subsidiary has seen results presented on its S.M.A.R.T peripheral vascular stent, which show durable 80% patency figures and improved patient outcomes.

Heartwire (theheart.org) has reported the findings of a group of cardiologists who have identified three cases of what they believe to be thrombosis on the prosthetic valve in people who have undergone transcatheter aortic-valve implantation (TAVI) in the preceding couple of years.

HydroCision, Inc., has been training its water jets on spinal procedures, now announcing positive results from its newly published multi-centre study.

The need for a more solid evidence-basis is an increasing one in medtech, and rightly so, companies and their reps having got away with unsubstantiated claims for too long. So are things changing or is it just the regulators who are raising the bar?

The first patient has been treated in the Boston Scientific’s ZERO AF clinical trial to evaluate the safety and effectiveness of the Blazer® Open-Irrigated Temperature Ablation Catheter in patients with symptomatic, drug refractory paroxysmal atrial fibrillation. This international, multi-center study will include up to 472 patients at 33 sites in the United States, Europe and Asia-Pacific.

Cardiac device and remote monitoring company Biotronik, has gained U.S. FDA approval to commence its ProMRI® clinical trial under an Investigational Device Exemption (IDE). Recruitment is underway.

Phoenix Cardiac Devices, Inc., a medical device company with a novel method of repairing leaky heart valves without open-heart surgery, has enrolled its first patient in a clinical trial aimed at achieving CE Mark approval in Europe.

GI Dynamics, Inc. has announced that it has initiated its U.S. multicentre pivotal clinical trial of EndoBarrier®, the ENDO Trial, for the treatment of patients who have uncontrolled type 2 diabetes and are obese.

While obese patients are more likely to have surgical treatment for lumbar disc herniation – a slipped or ruptured disc – than nonobese patients, obesity increases operative time, blood loss and length of hospital stay, according to new research published in the January 2013 Journal of Bone and Joint Surgery (JBJS).

The first patient has been recruited to a new clinical trial, which represents one of the largest global studies to examine the effectiveness of an advanced mechanical treatment in stroke care.