Xeris Pharmaceuticals (NSDQ:XERS) touted data this month for its ready-to-use glucagon auto-injector, highlighting the device’s efficacy and usability. The Chicago-based company’s rescue pen is under review for approval by the FDA as a treatment for severe hypoglycemia in people with diabetes. Get the full story at our sister site, Drug Delivery Business News.
Clinical Trials
AliveCor app matches ECG in signaling certain heart attacks
An international study has found that AliveCor’s smartphone app has nearly the same accuracy as a standard 12-lead ECG in monitoring heart activity and determining if someone is having an ST-segment elevation myocardial infarction (STEMI). The study led by researchers from the Intermountain Medical Center Heart Institute in Salt Lake City followed 204 patients with chest […]
Baxter touts Hemopatch, Floseal study results
Baxter (NYSE:BAX) today presented results from studies of its Hemopatch and Floseal products, touting reductions in costs and hospital stays in both trials. Results from studies of the devices were presented this week at the International Society for Pharmacoeconomics and Outcomes Research Europe 2018 meeting, the Chicago-based company said. In a retrospective observational analysis exploring pancreaticoduodenectomies […]
Philips launches below-the-knee PAD trial for drug-coated balloon
Philips (NYSE:PHG) said yesterday that it enrolled the first patient in a U.S. investigational device exemption trial for its Stellarex drug-coated balloon. The 354-patient Illumenate Below-the-Knee study is designed to assess the device’s safety and effectiveness compared to percutaneous transluminal angioplasty in people with critical limb ischemia. Get the full story at our sister site, Drug […]
Pilot trial of Abiomed’s Impella as heart attack treatment meets endpoints, pivotal to follow
A pilot trial exploring the use of Abiomed‘s (NSDQ:ABMD) Impella heart pump as a treatment for reducing the severity of heart attacks has met its primary safety and feasibility endpoints, clearing the way for a pivotal trial, according to primary investigator Dr. Navin Kapur. Results from the pivotal, if successful, could “change the paradigm of […]
Cardiva touts results from pivotal Vascade MVP vascular closure device trial
Cardiva Medical today released results from the pivotal study of its Vascade MVP vascular closure device intended for multi-access venous closure following electrophysiology procedures, touting that the trial met its primary and secondary endpoints. The results from the AMBULATE trial were presented today at the American Heart Association’s annual Scientific Sessions by Texas Cardiac Arrhythmia Institute […]
InCarda Therapeutics raises $42m for inhaled atrial fibrillation drug
InCarda Therapeutics said today that it raised $42 million in an oversubscribed Series B financing round led by Sofinnova and HealthCap. Proceeds from the round are slated to support a Phase II trial of the company’s inhaled paroxysmal atrial fibrillation drug, InRhythm. Get the full story at our sister site, Drug Delivery Business News.
Visioneering Tech touts NaturalVue contact lens pediatric myopia study
Visioneering Technologies Inc yesterday released results from a pediatric study of its NaturalView multifocal contact lens intended to treat myopia, touting Results from the trial were presented by study lead Dr. Thomas Aller of the UC Berkeley School of Optometry at the American Academy of Optometry Conference in San Antonio this week. In the trial, […]
FDA approves Medtronic renal denervation trial in on-med patients
Medtronic (NYSE:MDT) said today that the FDA approved a clinical trial of its Symplicity Spyral renal denervation device in patients who already take medication for their high blood pressure. Fridley, Minn.-based Medtronic said the three-year, 340-patient Spyral HTN-On Med sham-controlled study is designed to compare treatment with the Symplicity Spyral device and a sham procedure, randomized […]
VIVA 2018 Roundup: Surmodics reports positive one-year data for SurVeil drug-coated balloon
Surmodics (NSDQ:SRDX) touted data this week from an early feasibility study of the company’s SurVeil drug-coated balloon in patients with symptomatic peripheral artery disease due to de novo lesions of the femoral and popliteal arteries. All of the study’s 13 subjects met the acute success measures of safety at 12 months, Surmodics reported, and no […]
Trial shows BD balloon compares well with angioplasty for CLI
BD (NYSE: BDX) today touted the results of a clinical trial that showed “statistically significant safety equivalence” between its Lutonix 014 drug-coated balloon (DCB) and a standard angioplasty catheter (PTA) in treating narrowed or obstructed arteries below the knee. The trial’s primary safety endpoint—freedom from composite all-cause death, above the ankle or major reintervention of the treated limb […]