Treatment with another stent, rather than from a drug-coated or drug-eluting balloon, has been shown to be more effective in treating coronary in-stent restenosis, according to 2 new studies. The 2 studies, 1 European and 1 Japanese, were published in the Journal of the American College of Cardiology earlier this month. The 309-patient European Ribs […]
Clinical Trials
St. Teresa Medical launches Surgiclot system
St. Teresa Medical said yesterday it enrolled the 1st patient in a clinical trial of its Surgiclot clotting bandage. The company won approval for a 40-patient study of Surgiclot from the U.K.’s Medicines and Healthcare products Regulatory Agency in June, St. Paul, Minn.-based St. Teresa said. The 1st surgery using the bandage dressing was performed earlier […]
Pulmonx touts sham trial data
Pulmonx said earlier this month that a sham-controlled trial of its Zephyr endobronchial valve met and exceeded its primary endpoints, reporting a 20.9% average improvement in lung function. The Believer-Hifi study, published in The Lancet, is the 1st successful sham-controlled trial of any invasive emphysema device, Redwood City, Calif.-based Pulmonx said. “We have been able […]
House OKs 21st Century Cures bill for medical research
(Reuters) — The U.S. House of Representatives last week passed a sweeping bill to speed new medical devices and drugs to the market after lawmakers defeated last-minute amendments that threatened to derail it. The House voted 344-77 in favor of the 21st Century Cures Act, which would require the FDA to streamline its approval process, consider […]
Intersect Ent launches Nova sinus implant trial
Intersect ENT (NSDQ:XENT) said yesterday it enrolled the 1st patient in a trial of its Nova bioabsorbable steroid releasing sinus implant. The implant is designed to prop open the sinuses and deliver anti-inflammatory medication after surgical interventions, the Menlo Park, Calif.-based company said. “Clinical evidence to date has shown that Propel and Propel mini meaningfully […]
Gene therapy for deafness moves a few steps closer
(Reuters) — Gene therapy for deafness is moving closer to reality, with new research yesterday showing the technique for fixing faulty DNA can improve responses in mice with genetic hearing loss. Separately, a clinical trial backed by Novartis (NYSE:NVS) is under way to help a different group of people who have lost their hearing through […]
Biotronik launches CRT in women study
Biotronik said last week it enrolled the 1st patient in its Biowomen study investigating the difference in cardiac resynchronization therapy response in men and women to understand if women respond better to the treatment. The trial seeks to enroll 247 patients of each gender over 2 years, with a 1-year follow-up and results expected in 2018, the […]
Thoratec touts less-invasive HeartMate 3 implantation
Thoratec (NSDQ:THOR) yesterday revealed the 1st implantation of its next-generation HeartMate III implantable heart pump using a mini-thoracotomy approach. The implantation, part of a European trial designed to examine less-invasive procedures such as hemi-sternotomy and left thoracotomy, was the 1st of a planned 10 surgeries, Pleasanton, Calif.-based Thoratec said. “This achievement marks the latest step in our progress […]
InVivo shares jump on study results
InVivo Therapeutics (OTC:NVIV) shares jumped 10% today after the company released promising data on the 2nd and 3rd patients implanted with its investigational neuro-spinal scaffold. A 1-month checkup of the 3rd patient implanted with the scaffold reported an improvement from an A class injury on the American Spinal Injury Association Impairment Scale, indicating complete loss of […]
Medtronic touts 1-year data for VenaSeal device
Medtronic (NYSE:MDT) today touted results from its VeClose clinical trial of its VenaSeal varicose vein treatment, saying the device posted a 96.8% closure rate at 12 months. Results from the study were presented by principal investigator Dr. Nick Morrison of the Morrison Vein Institute in Scottsdale, Ariz., at the the European Venous Forum 2015 in St. Petersburg, Russia. VenaSeal […]
Diabetes: Study finds bariatric surgery beats diet, exercise
A study designed to compare bariatric surgery with lifestyle interventions found that Type II diabetics treated with gastric bypass or banding procedures fared better than patients who watched their diets and exercised. The question is, how much does it cost? Results from “Bariatric Surgery versus Intensive Medical Therapy for Diabetes – 3-Year Outcomes,” which was funded […]
