MassDevice

The Medical Device Business Journal — Medical Device News & Articles | MassDevice

Home » Cardiac Dimensions touts data from Carillon TMVR device study

Cardiac Dimensions touts data from Carillon TMVR device study

By

Cardiac Dimensions

Cardiac Dimensions today released results from a trial of its Carillon mitral contour system intended for treating functional mitral regurgitation in patients with heart failure, touting significant reductions in regurgitant volume after implantation.

Results from the trial were presented at the German Society of Cardiology annual congress, the Kirkland, Wash.-based company said.

The percutaneous Carillon device 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.

“The significant acute MR benefit demonstrated in our study, achieved by a device that cinches the mitral apparatus via the coronary sinus without compromising the valve or future treatment options, makes the Carillon System a front-line treatment option for FMR patients,” study co-author and presenter Dr. Stephan Stoebe said in a prepared release.

“Functional mitral regurgitation is associated with increased morbidity and mortality in patients with heart failure. For patients ineligible to receive surgical treatment, interventional techniques represent a new therapy option. The findings we presented confirmed the acute hemodynamic effects of the Carillon device on mitral valve morphology and demonstrated an acute reduction in regurgitant fraction in 83% of patients, as documented by transthoracic echo after device implantation,” study lead Dr. Andreas Hagendorff of the University of Leipzig said in a prepared statement.

The Carillon mitral contour system has had CE Mark approval in the European Union since 2011, the company said.

“We are pleased with the results from the University of Leipzig study validating the immediate impact of the Carillon System on mitral regurgitation for a large percentage of FMR patients. This study adds to the growing body of evidence demonstrating the effectiveness and safety of the Carillon System in two key measurements of FMR – a significant MR reduction and favorable left ventricular remodeling, observed most recently in the REDUCE FMR trial, the first and only randomized, blinded, sham-controlled trial conducted in structural heart,” prez & CEO Greg Casciaro said in a press release.

Last October, Cardiac Dimensions said that it won reimbursement from Germany’s Institute for the Hospital Remuneration System (InEK) for its Carillon mitral contour system.

In case you missed it

RSS From Medical Design & Outsourcing

  • TE Connectivity opens global medical device prototyping center in Ireland
    TE Connectivity (NYSE:TEL) today announced it opened its global Propelus Prototype Center for medical devices in Galway, Ireland. The $5 million rapid prototyping center was built into its existing manufacturing site in Galway and directly connects TE engineers with customers to reduce development time and increase speed to market for lifesaving and life-improving medical devices. Propelus… […]
  • Contract manufacturer Minnetronix Medical launches its first in-house product, MindsEye
    Minnetronix Medical has launched MindsEye, making it the first medical device that the contract developer and manufacturer has conceived and commercialized. St. Paul-based Minnetronix Medical’s MindsEye is the first expandable brain access port on the market. The FDA cleared the device under the 510(k) pathway in August 2020. The minimally invasive device gives neurosurgeons deep… […]
  • What’s next for Jennifer Fried after leaving Explorer Surgical?
    Explorer Surgical co-founder Jennifer Fried has resigned from the company after selling it to Global Healthcare Exchange in October. Fried announced her departure last week on LinkedIn, saying she’s preparing for her next professional chapter. “It’s bittersweet — I’m so proud of everything our team has built and accomplished,” Fried wrote. “The time has flown… […]
  • The 24 best medical device innovations of 2022
    The Galien Foundation recently announced its nominees of medical device innovations for its 2022 Prix Galien USA awards. There are 24 medical technologies nominated for the annual award this year, up from 18 nominees in 2021. The Galien Foundation’s annual Prix Galien awards highlight devices, biotechnology and pharmaceutical products designed to improve the human condition.… […]
  • FDA issues new COVID-19 testing guidance to avoid false negatives
    COVID-19 testing should be repeated following a negative result on any antigen test, the FDA said in a move that could increase demand for diagnostics manufacturers. The latest guidance from the federal health agency is for negative COVID-19 antigen test results regardless of the presence or absence of symptoms. The federal agency said recent studies… […]
  • Confluent Medical expands Costa Rica manufacturing footprint for nitinol, complex catheter production
    Confluent Medical Technologies this week announced the opening of its new addition to its Costa Rica manufacturing facility. The expansion adds 66,000 sq. ft to its large-scale manufacturing center of excellence in Alajuela, Costa Rica to expand Confluent’s capacity for nitinol component processing and complex catheter manufacturing. “Confluent has experienced consistent and strong growth in… […]
  • FDA’s breakthrough medical device designations tally nears 700
    Stewart Eisenhart, Emergo Group The US Food and Drug Administration has granted almost 700 designations over the past seven years under a voluntary program for expedited regulatory review of medical devices and combination products that facilitate more effective treatment or diagnosis of serious diseases. According to recent metrics published by FDA, the agency has issued a total of… […]
  • Lifecore Biomedical’s owner plans to go all-in on contract development and manufacturing
    Lifecore Biomedical parent company Landec Corp. (Nasdaq:LNDC) plans to take the subsidiary’s name, leadership and headquarters as its own and sell off food businesses to focus on contract development and manufacturing. Santa Maria, California-based Landec said it will rename itself as Lifecore Biomedical “in the near future” and change its Nasdaq ticker to LFCR. Landec… […]
  • COVID-19 immunity test developers at MIT seek diagnostic manufacturer
    MIT researchers have developed a device for predicting an individual’s COVID-19 immunity and are looking for a diagnostic company to get it manufactured in large numbers and approved by the FDA. The lateral flow test uses the same technology as at-home rapid antigen COVID-19 tests to measure neutralizing antibodies for SARS-CoV-2 in a blood sample,… […]
  • GE Healthcare picks AI imaging startups for inaugural Edison Accelerator
    GE Healthcare and Nex Cubed have selected seven companies focused on artificial-intelligence-augmented medical imaging for the first cohort of the Edison Accelerator in Canada. The companies will be matched with mentors and test their technologies with GE’s new Edison Digital Health Platform over the next three months. The program will end with innovation showcase presentations… […]
  • Boston Scientific whistleblower launches corruption investigation
    Boston Scientific (NYSE:BSX) is investigating claims that the company violated the U.S. Foreign Corrupt Practices Act in Vietnam. Marlborough, Massachusetts–based Boston Scientific disclosed receipt of a whistleblower’s allegations in its latest filing with the Securities and Exchange Commission. “In March 2022, the company received a whistleblower letter alleging Foreign Corrupt Practices Act violations in Vietnam.… […]