Bay Labs said today that it is renaming the company Caption Health and rebranding its flagship technology, EchoGPS, as Caption Guidance. The San Francisco-based company plans to incorporate Caption Guidance technology into compatible ultrasound devices and offer that product to the market as Caption AI. Caption AI is designed to allow for quick and accurate […]
Clinical Trials
LivaNova launches vagus nerve stim depression study
LivaNova (NSDQ:LIVN) said last week that it enrolled its first patient in a study of vagus nerve stimulation therapy for treatment-resistant depression. The Recover study is designed to determine whether active VNS therapy is a superior option compared to a no-stimulation control in producing a reduction in baseline symptom severity of depression. LivaNova plans to enroll […]
TCT 2019: Boston Scientific slides on Acurate Neo TMVR trial miss
The Acurate Neo replacement heart valve being developed by Boston Scientific (NYSE:BSX) failed to show non-inferiority in a head-to-head comparison with the Sapien 3 valve made by Edwards Lifesciences (NYSE:EW), according to study data released at the annual Transcatheter Cardiovascular Technologies conference in San Francisco. The 739-patient Scope I study randomized increased-risk patients to either Acurate Neo […]
TCT 2019: Medtronic’s Resolute Onyx non-inferior to Biosensors Biofreedom stent
A study comparing the Resolute Onyx drug-eluting stent from Medtronic (NYSE:MDT) and the BioFreedom stent made by Biosensors International (PINK:BSNRY) showed the Medtronic device to be non-inferior in patients on a one-month dual anti-platelet therapy regimen, according to results presented yesterday at the annual Transcatheter Cardiovascular Technologies conference in San Francisco. Medtronic launched the 2,000-patient study […]
FDA approves early feasibility study for new Medtronic TMVR
Medtronic (NYSE:MDT) said today that it has received FDA approval to begin an early feasibility study for its Intrepid transcatheter mitral valve replacement (TMVR) system using a minimally-invasive transfemoral access approach. The announcement builds upon primary endpoint outcomes of the Intrepid TMVR Apollo clinical trial using the transapical approach, published in the Journal of the […]
FemSelect closes enrollment for mesh-free pelvic floor device study
FemSelect yesterday said it closed enrollment in the EnPlace post-market study of its mesh-free pelvic floor repair device. The Tel Aviv, Israel-based company enrolled 60 female patients aged 36 to 84 years at 15 sites in the U.S., Germany and Israel for the global, two-phase study. The observational study will assess the long-term safety, durability […]
Cala Health touts top-line data on Trio wearable for essential tremor
Cala Health yesterday presented top-line data from a study of its Cala Trio therapy for treating essential tremor. Trio is a wrist-worn neuromodulation device designed to stimulate nerves responsible for the tremor to provide symptomatic relief. Burlingame, Calif.-based Cala Health said its Prospect trial, which is touts as the largest ever conducted for essential tremor, […]
Medtronic announces Infuse spine trial
Medtronic (NYSE:MDT) said today that it won FDA approval for a clinical trial of its Infuse bone graft in transforaminal lumbar interbody fusion spine procedures. The Minneapolis-based company started recruiting for the prospective, randomized pivotal trial, which is slated to enroll up to 1,000 patients. The TLIF trial would be the second clinical trial for Infuse, […]
Robocath touts R-One coronary angioplasty platform
Robocath said today that it completed its first two coronary angioplasties performed with its R-One robotic platform. Both procedures were performed in France, as Drs. Eric Durand and Rémi Sabatier oversaw one at Rouen University Hospital and Dr. Jean Fajadet performed one at Clinique Pasteur in Toulouse. The R-One system is designed to facilitate and enhance […]
FDA seeks input on patient engagement in clinical trials
The FDA has released draft guidance on how medtech manufacturers should involve patients in the design and conduct of clinical trials. The agency’s Patient Engagement Advisory Committee (PEAC) recommended the FDA work with industry to develop a framework that clarifies how patient advisors can engage in the clinical investigation process. Patient advisors are defined as […]
TAVR technique cuts pacemaker implantation rate
According to a new study, a new approach to self-expanding transcatheter aortic valve replacement could minimize the risk of permanent pacemaker implantation. The patient-specific approach was used in analyzing nearly 250 patients with severe aortic stenosis who underwent TAVR to look at factors contributing to PPMI, according to Medscape. The study was published by lead […]