Here’s a roundup from this week’s Transcatheter Cardiovascular Therapeutics convention in San Diego: Cardiac Dimensions said yesterday that a study of its Carillon mitral valve repair device met its primary endpoint, with the data presented at the annual Transcatheter Cardiovascular Therapeutics meeting in San Diego. Kirkland, Wash.-based Cardiac Dimensions said the Reduce FMR trial was […]
Abbott’s MitraClip study draws applause at TCT 2018
Startlingly positive results from a clinical trial of Abbott’s MitraClip heart valve device reportedly drew applause at the annual Transcatheter Cardiovascular Therapeutics meeting in San Diego yesterday. Abbott (NYSE:ABT) acquired MitraClip in the $410 million acquisition of Evalve back in 2009. The device, which is designed to reshape the mitral valve to prevent blood from flowing backwards through […]
TCT 2018: Boston Scientific wins FDA nod for drug-eluting vascular stent
On the heels of positive study results at the 30th Transcatheter Cardiovascular Therapeutics meeting, Boston Scientific (NYSE:BSX) won FDA approval for its drug-eluting vascular stent system, Eluvia. The device, which is designed for the treatment of peripheral artery disease, uses a drug-polymer combination to deliver paclitaxel over the course of a year. Get the full story at our […]
Cardiovalve launches pivotal TMVR trials
Israel cardiovascular device developer Cardiovalve said yesterday it launched both the Ahead US and Ahead EU multicenter studies of its Cardiovalve transfemoral mitral valve replacement system. The company’s flagship Cardiovalve system is a novel mitral valve designed for either transferal or transeptal use and is intended to replace the mitral valve through a minimally invasive […]
NIH kicks off study of combo antibody HIV therapy
The National Institutes of Health reported this week that it launched a clinical trial evaluating a combination of antibodies in people with HIV. The early-stage study is designed to assess whether periodic infusions of two HIV-specific antibodies are safe in people living with HIV. Researchers also plan to gather preliminary data assessing how effectively the infusions suppress […]
CSA Medical touts QoL improvements in RejuvenAir chronic bronchitis study
CSA Medical today released early results from a feasibility study exploring the use of its RejuvenAir Metered Cryospray system in treating patients with chronic bronchitis, touting improvements in quality of life for patients treated with the system. Results from the trial were presented at the 2018 European Respiratory Society Congress in Paris, the Boston-based company said. […]
Clovis forks over $20m to settle SEC charges that it misled investors
The SEC said today that Clovis Oncology (NSDQ:CLVS), its CEO and former CFO will pay more than $20 million to settle charges that the company misled investors about its experimental lung cancer drug. The SEC alleged that beginning in July 2015 and over the course of a four-month period, CEO Patrick Mahaffy and his team at Clovis […]
Cardiac Dimensions launches pivotal trial for Carillon mitral repair device
Cardiac Dimensions said today it launched a pivotal trial of the Carillon mitral valve repair device it’s developing, and that it enrolled and randomized its first patient in the trial. The Kirkland, Wash.-based company’s percutaneous Carillon annuloplasty device is designed to use a distal anchor and proximal anchor, connected by a shaping ribbon, to re-form the mitral annulus […]
LivaNova launches pivotal study for Vitaria heart failure device
LivaNova (NSDQ:LIVN) said today that it launched a pivotal study of its Vitaria neuromodulation implant for treating heart failure. The 800-patient Anthem-HFrEF study’s first subject was implanted with the Vitaria vagus nerve stimulation device at St. Luke’s Hospital in Cedar Rapids, Iowa, the London-based company said. Patients enrolled in the trial are slated to be randomized on […]
Medtronic launches study for bicuspid TAVR in low-risk patients
Medtronic (NYSE:MDT) said today that it’s launching a study of its CoreValve Evolut replacement heart valve in a low-risk patient population with a genetic form of heart disease, following a pair of FDA decisions about the treatment. The Fridley, Minn.-based medtech titan said the FDA granted an investigational device exemption for a single-arm trial of […]
AstraZeneca touts long-term safety, efficacy data for asthma biologic
AstraZeneca (NYSE:AZN) today touted results from a Phase III extension trial evaluating the long-term safety and efficacy of benralizumab as an add-on maintenance therapy for patients with severe eosinophilic asthma. Benralizumab, or Fasenra, is approved as an add-on maintenance treatment for severe eosinophilic asthma in an array of countries, including the U.S., the E.U., and Japan. […]
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