Medtronic (NYSE:MDT) said today it launched an FDA investigational device exemption study of its Abre venous self-expanding stent system, looking to explore the use of the device in subjects with iliofemoral venous outflow obstruction. The first procedure in the study was performed last month by national principal investigator Dr. Erin Murphy of Charlotte, N.C.’s Sanger Heart […]
Clinical Trials
Cefaly touts trial data showing outperformance of drugs for migraine abortion treatment
Cefaly yesterday released data from a trial of its Cefaly Acute device designed for the acute treatment of migraines, touting that its migraine abortion capabilities outperformed current published data on triptans and other medical drugs under investigation for the acute treatment of migraines. The New York City-based company’s flagship Cefaly Acute device is FDA-approved as […]
Tryton Medical launches post-approval study of Side Branch Stent system
Tryton Medical said yesterday it launched a post-approval study of its Tryton Side Branch Stent system designed for treating coronary artery disease. The side-branch stent is designed to be compatible with any conventional drug-eluting stent in the main vessel, and comes in sizes ranging from 2.5mm to 3.5mm, the Durham, N.C.-based company said. “Greater than 20% […]
Penumbra touts real-world study results in Penumbra System acute ischemic stroke trial
Penumbra (NYSE:PEN) today released results from the Promise real-world safety and efficacy study of its Penumbra System with ACE 68 and 64 reperfusion catheters as a treatment for patients with acute ischemic stroke, touting high rates of revascularization and low rates of all-cause mortality. Results were presented at the International Stroke Conference this week in Los Angeles. […]
Bovie Medical launches IDE J-Plasma dermal skin resurfacing study
Bovie Medical (NYSE:BVX) said today it launched an FDA investigational device exemption clinical study of its J-Plasma surgical cutter, looking to explore the use of the device in dermal skin resurfacing. The first patient in the trial was enrolled by Dr. J. Holcomb at Sarasota, Fla.’s Institute for Integrated Aesthetics. The J-Plasma device is a plasma-based cutter […]
Medtronic launches Endurant II, IIs ChEVAR real-world study
Medtronic (NYSE:MDT) said today it launched a study of its Endurant II and IIs stent graft systems, designed to treat abdominal aortic aneurysms, exploring the use of the device in ChEVAR procedures in real-world settings. The 150-patient, single-arm study is slated to enroll patients at 25 sites across Europe and Russia, with the first enrollments already […]
Imagin Medical enrolls 1st patients in i/Blue Imaging study
Imaging solution developer Imagin Medical said yesterday it recruited the initial subjects in a first-in-human study of its i/Blue Imaging System. The company is developing the ultrasensitive i/Blue Imaging System which it hopes will “establish a new standard of care” for detecting certain cancers and visualizing the surgical field during minimally invasive surgery, with an initial focus […]
Leaf Healthcare touts reduced pressure injuries in Leaf wearable sensor study
Patient monitoring system developer Leaf Healthcare today released results from a study exploring the ability of its Leaf wearable patient sensor to prevent pressure injuries on acutely ill adults, touting that patients were 73% less likely to develop such injuries when monitored with the device. Results from the study were published in the online issue of the […]
Masimo touts ORi obese patient arterial hemoglobin desaturation warning study results
Masimo (NSDQ:MASI) yesterday released results from a study of its Oxygen Reserve Index’s ability to function as an early warning of impending arterial hemoglobin desaturation in obese patients, touting its ability to provide advanced warning in the high risk patient population. An abstract from the study, which Masimo claims is the first published research investigating the […]
Pulmatrix wins EU nod for inhaled dry-powder anti-fungal trial
The UK Medicines and Healthcare Products Regulatory Agency has given Pulmatrix (NSDQ:PULM) the go-ahead to launch its first-in-human study for an inhaled formulation of the anti-fungal drug, itraconazole. The company is evaluating its drug, Pulmazole, as a treatment for allergic bronchopulmonary aspergillosis in patients with asthma. Get the full story at our sister site, Drug Delivery Business […]
Laminate Medical launches study of VasQ hemodialysis fistula device
Laminate Medical Technologies said today it launched a pivotal, FDA-cleared trial of its VasQ implanted blood vessel device designed for patients requiring arteriovenous fistulas as vascular access for hemodialysis. The Israel-based company’s VasQ device is designed to aid kidney failure patients in need of dialysis by providing external support to reduce fistula failure. The device regulates […]