MassDevice

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

Home » CorWave touts ‘unprecedented’ study results

CorWave touts ‘unprecedented’ study results

By

CorWaveCorWave announced today that chronic in vivo studies of its implantable heart pump have proven “unprecedented” with strong results.

Presenting at the annual meeting for the International Society for Heart and Lung Transplantation (ISHLT), CorWave touted the study as the first ever to demonstrate sensorless synchronization of a pericardial pump with the native heart for over 30 days, according to a news release.

Clichy, France’s implantable left ventricular assist device (LVAD), which uses its breakthrough wave membrane pump technology, is designed to offer a wide range of flow conditions, gentle blood propulsion and to generate physiologic pulsatility in an effort to reduce the adverse events associated with current LVAD technologies.

Study results from the trials in which the CorWave device operated in pulsatile mode by synchronizing with the native heart without the aid of sensors demonstrated more than 97% success in detecting heartbeats. CorWave said that is the first time in the world that a miniaturized, pericardial pump has accomplished such a feat.

The 30-day results also provided confirmation of the success with CorWave’s LVAD in hemocompatibility, the company said, representing a major milestone in the device development.

“This study is an important step towards making our next-generation heart pump available to patients with advanced heart failure,” CorWave CEO Louis de Lillers said in the release. “Indeed, we demonstrated that our pump is able to work in synchrony with the native heart and can be a game-changer for the LVAD therapy. Congratulations to our team for achieving this milestone in the development of our breakthrough technology. With this study, they are redefining the state of the art in the field of mechanical circulatory support, by succeeding in doing what current devices cannot do.”

In January, CorWave raised $40 million to aid in finalizing the device, producing the heart pumps and starting clinical trials. The company said the recent study results will allow the development of the pump to complete ahead of production and those clinical trials.

In case you missed it

RSS From Medical Design & Outsourcing

  • 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.… […]
  • 5 essential leadership lessons from Cathy Burzik for medtech’s next generation of women leaders
    Cathy Burzik, a seasoned senior executive in the healthcare industry, has successfully led major medical device, diagnostic, diagnostic imaging and life sciences businesses. Cathy Burzik, CFB Interests (as told to MedExecWomen co-founder Maria Shepherd) One key to being a successful women leader in MedTech: “Play nice, but play to win.” Cathy Burzik, who received a… […]
  • Stratasys plans to buy Covestro’s additive manufacturing business
    Stratasys (Nasdaq:SSYS) said today that it has a deal to purchase the additive manufacturing materials business of Covestro. The deal includes R&D facilities and activities, global development and sales teams across Europe, the U.S. and China, a portfolio of approximately 60 additive manufacturing materials, and hundreds of patents and patents pending, Stratasys said in a… […]