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XVIVO Perfusion granted Breakthrough Device Designation from the FDA for the XVIVO Heart Preservation System

XVIVO Perfusion has been granted ‘Breakthrough Device Designation’ from the U.S. Food and Drug Administration (FDA) for the XVIVO Heart Preservation System (XHPS), indicated for the hypo-thermic non-ischemic perfusion of excised donor hearts for preservation prior to transplant. The Breakthrough Device Designation is intended to expedite the development and prioritize the review of certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.The Center for Devices and Radiological Health (CDRH) of the

XVIVO has received market approval (PMA) from the FDA for STEEN Solution™ and XPS™

On April 26, 2019 XVIVO received Premarket approval (PMA) from the FDA for the products XPS™ and STEEN Solution™ for sale on the American market. The approval means that STEEN Solution™, XPS™ and the accompanying single-use articles are the only medical device products that are approved for Ex Vivo Lung Perfusion (EVLP) of initially unacceptable donated lungs at body temperature.Please see FDA press release on the following link: https://www.fda.gov/news-events/press-announcements/fda-approves-device-help-increase-access-more-lungs-transplant Just over 40 percent of all lung

UNITED THERAPEUTICS AND XVIVO PERFUSION ANNOUNCE COLLABORATION TO REDUCE ORGAN SHORTAGE THROUGH EXPANSION OF ORGAN EVALUATION SERVICE

Silver Spring, MD and Englewood, CO, June 12, 2018: United Therapeutics Corporation (Nasdaq: UTHR) and XVIVO Perfusion, Inc., a subsidiary of XVIVO Perfusion AB (STO: XVIVO), today announced that the use of XVIVO’s ex-vivo lung perfusion (EVLP) technology will be incorporated into the Silver Spring, Maryland laboratory of Lung Bioengineering Inc., a subsidiary of United Therapeutics’ public benefit corporation subsidiary Lung Biotechnology PBC. “I am excited about trying to make more life-saving use of donated lungs via XVIVO Perfusion’s pioneering technology,” said Martine Rothblatt, Ph.

PMA application for XPS™ with STEEN Solution™ submitted to the FDA

XVIVO Perfusion has submitted the PMA (Premarket Approval) application for the XPS™ with STEEN Solution™ to the FDA. The NOVEL Extension Clinical trial, that completed enrollment in 2017 constitutes the basis of the company’s PMA application.Lung transplantation remains a last treatment option for patients with end stage lung disease. Unfortunately, the lung is one of the least transplanted organs, leaving many patients with end stage lung disease to die without ever receiving a lung transplant. In 2016, 2322 patients received lung transplants in the US, 136 patients were removed from the

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