Covidien plc (NYSE:COV) said it has enough patients to evaluate the effectiveness of an arterial plaque removal system it acquired in its buyout of ev3 Inc. last year.
The Mansfield, Mass.-based company completed enrollment for an 800-patient study of the SilverHawk atherectomy system. The device is designed to cut away plaque lining the peripheral arteries in the legs and feet. The study, Definitive LE, aims to evaluate whether treated arteries remained unobstructed in patients with claudication (or difficulty and pain walking or standing) and whether doctors could save the limbs of patients with critical limb ischemia a year after treatment.
The Definitive LE study is the largest ever post-market peripheral arterial disease device study, according to Covidien, with 47 centers in both the U.S. and Europe participating.
"This trial is large enough to provide excellent comparisons to all major trials currently available and understand how this approach works within a large but diverse patient population," St. Elizabeth’s Medical Center interventional cardiology chief Dr. Lawrence Garcia said in prepared remarks. Garcia is the study’s principle investigator.
Covidien acquired the SilverHawk product family when it bought out Minnesota-based vascular treatment device maker ev3 Inc. for $2.6 billion last July.
Here’s a roundup of recent clinical trial and scientific study news:
- Doc presents Orthovita clinical results on Vitagel surgical hemostat
Orthovita Inc. (NSDQ:VITA), an orthobiologics and biosurgery company, is pleased to announce that Michael Bloomfield, M.D., of Cleveland Clinic, presented results of a study entitled “Prospective Randomized Evaluation of a Collagen/Thrombin and Autologous Platelet Hemostatic Agent During Total Knee Arthroplasty” on Friday, April 8, at the 29th Annual Meeting of the Mid-America Orthopaedic Association in Tucson, Arizona. Wael Barsoum, M.D. and Alison Klika, M.S. of the Cleveland Clinic, Cleveland OH, served as the principal investigators of the study.
- Baxter touts Phase III study data on ARTISS for facelift surgery
Baxter International Inc. (NYSE:BAX) announced the results of a phase III study evaluating the safety and efficacy of ARTISS [Fibrin Sealant (Human)] in 75 patients. The study compared the total drainage volume for each side of the face at 24 hours post rhytidectomy, or face lift surgery. This data was presented at the American Association of Plastic Surgeons (AAPS) 90th Annual Meeting on April 10 in Boca Raton, Fla.
- Enigma commences U.S. trials for influenza A/B detection test
Enigma Diagnostics announced that it has commenced clinical trials for its intended point of care Enigma ML Influenza A/B detection assay. Enigma will submit its application to the FDA for approval of the assay in 2012.
- Masimo touts pulse oximetry study
Masimo (NSDQ:MASI) announced that a new study published in this month’s issue of the European peer-reviewed journal Acta Paediatrica demonstrates that pulse oximetry makes a critical difference in neonatal resuscitation both in terms of reliability and speed of measurements. In comparing the measurement response times of three different pulse oximetry technologies, researchers found that the Masimo Radical-7 pulse oximeter with Masimo SET Measure-Through Motion and Low Perfusion technology displayed reliable oxygen saturation (SpO2) measurements three to four times faster than competing pulse oximeters.
- Cerapedics touts bone graft study
Cerapedics Inc., a medical device company focused on developing and commercializing novel osteobiologic products, announced the results of a prospective, randomized, controlled trial of its i-FACTOR biologic bone graft for patients undergoing posterior lumbar interbody fusion (PLIF) spine procedures. The trial was performed by Philippe Lauweryns, MD, PhD from the Department of Orthopaedic Surgery, Regionaal Ziekenhuis Sint Trudo Hospital in Sint Truiden, Belgium.
- NewCardio touts heart attack study for diabetics
NewCardio Inc., (OTC:NWCI) a cardiac diagnostic technology provider, announced that the Company has been invited by the American Diabetes Association (ADA) to present the results of a key study showing that NewCardio’s urgent care solution, my3KG, had substantially greater accuracy than expert cardiologists’ interpretation of standard 12-lead ECG (12L ECG) in diagnosing Acute Myocardial Infarction (AMI) in diabetic patients.
- Get With The Guidelines Hospitals deliver equitable and improved care for HF patients
U.S. hospitals participating in the American Heart Association’s Get With The Guidelines–Heart Failure quality improvement program provided improved and equitable care for black, Hispanic and white heart failure patients.
- Durect touts chronic lower back pain study
Durect Corp. (NSDQ:DRRX) announced today top-line results from a Phase II clinical trial in chronic low back pain for ELADUR (TRANSDUR-Bupivacaine), DURECT’s proprietary investigational transdermal bupivacaine pain patch. This study was conducted by DURECT’s collaborator, King Pharmaceuticals, which is now owned by Pfizer (NYSE:PFE).
- Is the wrist bone connected to the heart muscle
Measuring the wrist bone may be a new way to identify which overweight children and adolescents face an increased risk of developing cardiovascular disease, according to research in Circulation: Journal of the American Heart Association.
- CT method gets calcium score and coronary anatomy all in one scan
Coronary calcium can be accurately quantified with a single standard-contrast computed tomography (CT) scan, thereby eliminating the added radiation exposure of a follow-up noncontrast scan, according to research presented at the American College of Cardiology 2011 Scientific Sessions last week, writes heartwire.