Clinical Studies/Trials

In a Monday morning mood to challenge everything that gets touted as evidence, we have a bit of a nibble at research claims that articular cartilage degeneration can be reversed with a hydrogel infill.

When a company enters into a study as big as this one, it must be pretty confident of a favourable outcome. In the case of Medtronic’s New CRT-P study the company will win big if it can show patient benefit from treating earlier stage heart failure.

Drug resistant depression is a problem with a new solution in the U.S. now that the FDA has given Brainsway’s non invasive magnetic stimulation device the nod.

Abbott’s newly announced Absorb™ absorbable stent trial is unquestionably huge, the number probably driven by the quest for significant results and the additional study end points identified in the protocol. Data from the ABSORB III trial will support U.S. regulatory filings for the device.

Stentys is trumpeting results from its APPOSITION II clinical trial, published in the December issue of JACC Cardiovascular Interventions, which suggest their device completely prevents gapping between stent and vessel wall.

Heart assist device company Thoratec Corporation has announced that the U.S. FDA has granted an Investigational Device Exemption (IDE) to commence the REVIVE-IT study utilising the HeartMate II® Left Ventricular Assist System.

Covidien is trumpeting the five-year results of its ClosureFast™ Long-Term European Multi-Centre Study in patients with Chronic Venous Insufficiency. 92% of patients still had effective occlusion of target vessels after five years, supporting the claim that the treatment is durable in the longer term.

Californian device company Nanostim, Inc., has announced the first successful implants of a leadless pacemaker in a series of 11 patients at Homolka Hospital in Prague, Czech Republic.

A new study, entitled “TandemHeart to Reduce Infarct Size” (TRIS) will determine effect of ventricular unloading on myocardial salvage after acute myocardial infarction.

A new paper, published in the European Heart Journal shows home-monitored patients experience 71% fewer delivered shocks and a 52% reduction in inappropriate shocks compared with a control group.

Published data demonstrate the Symplicity™ renal denervation system provides blood pressure reduction in patients with treatment-resistant hypertension sustained to 12 months

St. Jude Medical, Inc. has announced the first patient enrollment in its ILUMIEN I clinical study, designed to show the way Optical Coherence Tomography can optimally guide stent implantation in patients with coronary artery disease.

A first patient has been implanted with Boston Scientific’s new INGEVITY™ pacing leads in a clinical trial designed to establish the safety, performance and effectiveness of the leads.

MIS spine company SI-BONE, Inc. has seen the first peer-reviewed publication of clinical study results using its iFuse minimally invasive sacroiliac joint fusion device. At the same time the company has announced that it has reached the 5000 patient landmark.

Fziomed has filed a petition for reconsideration as FDA knocks back its PMA for spinal anti-adhesion barrier gel, Oxiplex. The FDA panel voted 5-2 against approval, citing unconvincing efficacy data from the company’s 352 patient study.

Covidien’s eV3 subsidiary business brought with it the Pipeline embolisation device when it was acquired. While the device shows encouraging results in patients with certain types of difficult-to-treat brain aneurysms, a new report suggests there are also reasons for some caution over fatal bleeds.