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

The Center for Devices and Radiological Health (CDRH) of the FDA has informed XVIVO that the combination product and proposed indication for use has met the criteria and have been granted designation as a Breakthrough Device. The proposed indications for use include The XVIVO Heart Preservation System (XHPS), used in conjunction with Supplemented XVIVO Heart Solution (SXHS), is indicated for the hypothermic non-ischemic perfusion of excised donor hearts for preservation prior to transplant. The device is intended to be used for all standard criteria donor hearts with the intention of transplant into a recipient aged 18 or older on a heart transplant waiting list.

The Breakthrough Devices Program is a voluntary program for certain medical devices that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions. The overall goal of the Breakthrough Devices Program is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment, and review, while preserving the statutory standards for premarket approval, 510(k) clearance, and De Novo marketing authorization, consistent with the FDA's mission to protect and promote public health.

“The ‘Breakthrough Device Designation’ granted to XVIVO offers a great opportunity to interact with the FDA and they will also provide XVIVO with a priority review and interactive communication regarding device development through to clinical trial protocols” says Dr. Magnus Nilsson, CEO of XVIVO Perfusion AB.

December 16, 2019
Gothenburg
XVIVO Perfusion AB (publ)
Magnus Nilsson, CEO