The FDA wrote a letter to healthcare providers yesterday on the heels of a meta-analysis that suggested an increased mortality rate after two years in people with peripheral artery disease who were treated with paclitaxel-coated and paclitaxel-eluting devices compared to bare devices. The agency is “evaluating” the new information presented by the study and recommended […]
Stimwave touts 6 month MIS SCS trial results
Stimwave today touted six-month data from a trial of its minimally invasive spinal cord stimulator system. The company’s pivotal Surf trial compared a variety of waveform options without the need for separate trial devices. Stimwave reported that in the high and low frequency groups, back and leg pain responders were more than 92% and 86%, […]
Medtronic kicks off study for pain pump
Medtronic (NYSE:MDT) said today that it enrolled the first patient in a study to assess the use of its SynchroMed II intrathecal drug delivery system as an alternative to oral opioids. The 100-patient Embrace TDD study is slated to follow patients who have weaned off all oral opioids, in the hopes of positioning the SynchroMed II […]
Cala Health launches trial for Cala Two neurostim device for essential tremor
Cala Health last month launched a clinical trial of the latest version of its wearable neurostimulator for treating essential tremor, eyeing extended use of the wrist-worn device. The Burlingame, Calif.-based company won de novo clearance from the FDA last April for the Cala One device for transient relief in adults with essential tremor. The 500-patient, single-arm […]
QT Vascular expands pivotal trial of Chocolate Touch DCB
QT Vascular said today that the FDA approved the company’s request to expand an on-going pivotal study of its Chocolate Touch drug-coated balloon to include the use of atherectomy for lesion preparation. The U.S. regulatory agency also approved the addition of subgroup analysis related to the use of atherectomy. Get the full story at our sister […]
Researchers question use of antibiotic shunts in hydrocephalus patients
Led by neurosurgeon Dr. Benjamin Warf, a team of researchers from Boston Children’s Hospital published a study this month questioning the benefits of using shunts impregnated with antibiotics to treat hydrocephalus. Hydrocephalus, which affects roughly 400,000 children each year, is characterized by fluid accumulation in the brain. Surgeons use shunts to drain the patient’s excess fluid and antibiotic shunts […]
Shockwave Medical launches U.S. pivotal for coronary lithotripsy
Shockwave Medical said today that it launched a U.S. pivotal trial for its coronary lithotripsy device, which is designed to prepare heavily calcified coronary lesions for stenting. The technology uses sonic pressure waves to fracture intimal and medial calcium without damaging arterial tissue, Santa Clara, Calif.-based Shockwave said. Last April the Shockwave S4 catheter, designed to similarly treat […]
Gynesonics touts 1-year pivotal IDE Sonata trial data
Gynesonics yesterday released 12 month results from the FDA investigational device exemption pivotal trial of its Sonata system intended for diagnostic intrauterine imaging and the transcervical treatment of symptomatic uterine fibroids. Results from the trial were published in the journal Obstetrics and Gynecology, the Redwood City, Calif.-based company said. The company’s flagship Sonata System is a […]
SightGlass Vision launches trial for pediatric myopia-controlling eyeglasses
Opthalmalogical device maker SightGlass Vision said yesterday that it launched a pivotal clinical trial exploring the use of its novel lenses designed to reduce the rate of progression in children between six and nine years old. The Palo Alto, Calif.-based company’s Cypress trial is a multicenter, double-blinded, randomized controlled clinical trial that aims to enroll […]
Report: Medtronic, Boston Scientific stand by paclitaxel-eluting devices despite JAHA study
Major medtech players Medtronic (NYSE:MDT) and Boston Scientific (NYSE:BSX) continue to support the use of their paclitaxel-eluting devices in the legs after a study released last month indicated a link between the devices and an increased mortality rate, according to a Star Tribune report. In the meta-analysis, researchers led by Dr. Konstantinos Katsanos analyzed data from 28 […]
Hancock Jaffe sets endpoints for FIH VenoValve study
Hancock Jaffe Laboratories (NSDQ:HJLI) today announced the endpoints for its planned first-in-human study of its VenoValve device. The VenoValve is a porcine valve designed to be implanted into the femoral or popliteal vein to treat lower limb chronic venous insufficiency from damage to leg vein valves after deep vein thrombosis, the Irvine, Calif.-based company said. Endpoints for […]
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