Clinical Studies/Trials

TEI Biosciences, Inc. has gained FDA Investigational Device Exemption (IDE) approval to initiate a human clinical trial to gain specific … continue reading “Trial Will Test SurgiMend® PRS Breast Cancer Reconstruction Claims”

Cardiovascular Systems, Inc. unveiled new data from its CONFIRM study series in three poster presentations at the 2013 New Cardiovascular … continue reading “New Data Supports Orbital Atherectomy For PAD In “Real World” Population”

Data from two European studies of Abbott’s MitraClip® therapy for the treatment of mitral regurgitation demonstrated low rates of hospital mortality and adverse events and significant improvements in day-to-day quality of life at one year following treatment

Needle-free glucose monitoring device company Echo Therapeutics, Inc. has announced that it is initiating a multi-center clinical trial of its Symphony CGM System to support a CE Mark submission. The Company expects to enroll patients over the coming weeks and announce the results of the study in the third quarter of 2013.

St. Jude Medical, Inc. has gained U.S. FDA approval to begin the EnligHTN IV Renal Denervation Study, the first U.S. trial using the EnligHTN™ Multi-Electrode Renal Denervation System to treat patients with drug-resistant high blood pressure.

To date, there are no drug-coated balloons indicated in the US for peripheral arterial intervention, despite their successful adoption and growing clinical pedigree in Europe. A new study might just see C R Bard’s Lutonix drug balloon over the line first.

Medtronic, Inc. is trumpeting with new data on its Endurant AAA stent graft, which it says demonstrates durable clinical performance through three years of patient follow-up in the endovascular repair of Abdominal Aortic Aneurysms.

Heart device and monitoring company Biotronik, has completed enrollment for its the highly anticipated IMPACT study. The study aims to investigate whether the use of Biotronik Home Monitoring® in conjunction with anticoagulation can reduce the risks of stroke, systemic embolism and major bleeding in cardiac device patients

Medtronic, Inc. tells us that that enough patients have been enrolled in its clinical studies of the IN.PACT Admiral drug-eluting balloon to support the company’s U.S. regulatory approval submission of the novel angioplasty device, which is designed to treat atherosclerotic lesions in the superficial femoral artery.

The FDA has granted 510(k) clearance to a muscle and joint rehabilitation medical device that tricks the brain into re-establishing communication with muscles affected by brain or spinal cord damage.

Another one of the renal denervation big boys sees data presented which confirms sustainable blood pressure reduction. This time its Boston Scientific, seeing clinical results using its recently acquired Vessix balloon-based system.

The Helio System (TF-FA) is a new investigational device, being developed for use with the Sapien XT Transcatheter Heart Valve. Results from a small, first-in-human feasibility study of its successful use in high-risk aortic insufficiency were reported at EuroPCR 2013.

EuroPCR has been the main focus of medlatest’s editorial this week. We’ve spotted a growing trend for companies to use vehicles like ours to get their news across. Never has that been more evident than this week, which has seen an unprecedented number of winning tales.

InspireMD 6-month results from the MASTER (MGuard for Acute ST Elevation Reperfusion) trial demonstrate that the MGuard Embolic Protection Stent (EPS) outperformed bare metal and drug eluting stents in all-cause mortality in ST segment elevation myocardial infarction (STEMI) patients.

Medtronic, Inc. has announced it has finished randomizing Symplicity HTN-3, the company’s pivotal U.S. clinical trial of the Symplicity™ renal denervation system for treatment-resistant hypertension. The company is hoping this is a landmark in its progress towards U.S. approval.

New long-term data from the DIVERGE study, presented at this week’s EuroPCR 2013 congress has shown that the use of … continue reading “Five Year Data For Axxess™ Self-Expanding Bifurcation DES”