Mitria Medical today announced the first implantation of its novel Subvalvular Spacer (SVS) device in the U.S.
The implantation procedure came under the FDA’s Single Patient Expanded Access Program, also called “compassionate use.” It allows a patient with a serious, immediately life-threatening condition to access an investigational medical product outside of clinical trials when they have no satisfactory alternatives. The procedure took place at the Cleveland Clinic, which established Mitria Medical as a portfolio company in 2019.
Dr. Jose Navia, vice chief, Heart, Vascular & Thoracic Institute, Cleveland Clinic Florida, and Dr. Samir Kapadia, chair, Department of Cardiovascular Medicine, Cleveland Clinic, have equity ownership rights as co-inventors of the SVS.
Mitria Medical designed its SVS system to treat mitral regurgitation (MR). Current available treatments for the disease include transcatheter edge-to-edge repair (TEER), for which companies like Abbott, Edwards and more offer technologies.
SVS was designed as a nitinol braid that sits at the hinge of the posterior leaflet. Mitria Medical aims for the device to provide broad support underneath the displaced leaflet to restore coaptation while preserving the valve’s natural motion and orifice area.
The company designed SVS to address posterior leaflet tethering, preserve leaflet motion and provide an anatomically versatile transcatheter option for the treatment of functional MR, (FMR).
Successful use of the SVS system comes on the heels of previous implantations in Tashkent, Uzbekistan, and Asunción, Paraguay.
Commentary from Mitria Medical officials and SVS co-inventors
Rick Geoffrion, chair of the board of directors of Mitria Medical, said:
“The successful treatment of this patient with severe functional mitral regurgitation represents a significant milestone for Mitria Medical. We are honored to have worked with the world-class clinical team at Cleveland Clinic to provide our therapy to this patient. This success reinforces our confidence in the ability of the Subvalvular Spacer to address complex mitral valve regurgitation through a minimally invasive transcatheter approach.”
Navia said:
“Although percutaneous treatment options for mitral regurgitation are available and well-established, there are patients who are ineligible for these therapies because of their anatomy. This new device may provide an important treatment option and help overcome some of the limitations of current therapies for patients with functional mitral regurgitation.”
Kapadia said:
“Continued innovation is essential due to the complex morphology of mitral valve disease. The device performed as intended, and we are looking forward to further clinical evaluation of this promising technology.”
