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 […]
VentureMed launches Flex scoring catheter study
Vascular focused device developer VentureMed said yesterday that it launched a new study of its Flex dynamic scoring catheter, exploring whether the device reduces dissections and the need for bailout stents in peripheral arteries. In the newly launched iDissection Classification study, investigators will use intravascular ultrasound to identify the health of vessels after treatment with the Flex […]
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 participants […]
TriSalus touts data for pressure-enabled drug-delivery tech
TriSalus Life Sciences touted results today from a Phase Ib trial of its pressure-enabled drug-delivery tech for immunotherapy. The company reported that delivering a concentrated dose of CAR-T cells at the site of a solid tumor using its technology was safe and contributed to positive clinical results. Get the full story at our sister site, Drug […]
Boston Scientific’s Eluvia drug-eluting stent succeeds in long lesions
Boston Scientific (NYSE:BSX) touted one-year data today from an analysis of its Eluvia drug-eluting vascular stent system, showing that the device is safe and effective in patients with long, complex, calcified lesions. The data were presented by Boston Scientific at the annual Vascular Interventional Advances meeting. Get the full story at our sister site, Drug Delivery Business […]
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