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 a sham-compared study of patients treated with Carillon, which is designed to use a distal anchor and proximal anchor, connected by a shaping ribbon, to re-form the mitral annulus by bending the coronary sinus. Late last year the FDA granted an investigational device exemption for a 400-patient pivotal trial of the Carillon device. That pivotal study enrolled its first patients just this month.
Results from the 120-patient Reduce FMR study revealed yesterday showed statistically significant reductions in functional mitral regurgitation in both the treatment arm and an intention-to-treat analysis. Of the 87 patients treated with Carillon, the FMR rate fell -22% after a year, compared with an 8% increase for the 33 patients in the sham control arm.
The study also showed a lower adverse event rate for the treatment arm compared with the control arm, at 16% versus 18%, respectively, with recurrent heart failure hospitalizations at 11% for the treatment arm compared with 21% for the control arm.
Secondary analyses showed that left ventricular end diastolic volumes were reduced in the treatment group and increased for the control arm at a year (-8.6 vs +6.5, respectively); left ventricular end systolic volumes were likewise reduced for the Carillon-treated population but increased for the control arm (-4.8 vs +6.1, respectively.
“I am impressed the trial results are consistent with the positive outcomes I’ve seen in my practice,” Dr. Horst Sievert, who presented the data at TCT 2018, said in prepared remarks. “When we designed this study, we knew a blinded, sham-controlled trial would be challenging, but the validity of the results would therefore be very compelling. And it is.”
“We are pleased with these positive results, which come on the heels of enrollment of the first patient in our Carillon pivotal trial, announced last week – the next step toward bringing the Carillon device to patients in the United States,” added Cardiac DImension CMO Dr. Steve Goldberg. “We look forward to gathering further clinical evidence to increase our understanding of the benefits of the Carillon device.”
In other TCT 2018 news:
- Valve-in-valve TAVR: High mortality but big benefits: Although one-third of patients who undergo transcatheter aortic valve replacement for their failing surgically implanted valves die after three years, those who survive enjoy significant clinical and quality-of-life benefits, according to data from the Partner II study revealed at TCT 2018. Read more
- Similar safety profiles for Medtronic’s Evolut R, Edwards’ Sapien 3: Patients treated with self-expanding transcatheter aortic valve replacements or with balloon-expanded TAVR devices showed similar safety profiles at 30 days, according to the Solve-TAVI trial. Read more
- Mismatched valves lead to higher mortality, readmissions: Patients implanted with TAVR devices that are not sized properly showed higher rates of inadequate blood flow, death and hospital readmission at 30 days, according to an analysis of 62,125 patients in the U.S. STS/ACC Transcatheter Valve Therapy Registry and administrative claims data from the Centers for Medicare & Medicaid Services for 37,470 of the registry patients. Read more
- Ancora Heart touts interim results from AccuCinch feasibility study: Interim results from 16 patients in a feasibility study of Ancora Heart’s AccuCinch ventricular repair system showed “a favorable safety profile with consistent procedural safety at 30 days, including no major adverse cardiac events and no device-related deaths” and “a reduction in left ventricular volume by an average of 29%,” the company said. Read more
- Cardia’s Ultraseal LAA closure device shows early promise: The Ultraseal device made by Cardia, designed to close the left atrial appendage, showed comparable safety outcomes compared with more established LAA closure devices from Boston Scientific (NYSE:BSX) and Abbott (NYSE:ABT). The 126-patient study showed a device success rate of 97%, a major peri-procedural adverse events rate of 2.4% and a rate of significant pericardial effusion of 0.8%. Read more
- Medtronic touts CoreValve studies: The world’s largest medical device business touted five-year data from the pivotal study of its CoreValve TAVR device and two-year data from the intermediate-risk Surtavi trial. Read more