Mitria Medical has announced the first implantation of its novel Subvalvular Spacer (SVS) in the USA under the US Food and Drug Administration (FDA) single patient expanded access programme.
Also known as “compassionate use”, this designation allows a patient with a serious, immediately life-threatening condition to access an investigational medical product outside of clinical trials when no satisfactory alternative options are available. The procedure was performed at Cleveland Clinic.
“The successful treatment of this patient with severe functional mitral regurgitation represents a significant milestone for Mitria Medical,” said Rick Geoffrion, chairman of the board of directors of Mitria Medical. “We are honoured 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.”
Mitria Medical’s SVS is a novel device designed to address posterior leaflet tethering, preserve anterior leaflet motion and provide an anatomically versatile transcatheter option for the treatment of functional mitral regurgitation (FMR).
“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,” said Jose Navia, vice chief, Heart, Vascular & Thoracic Institute, Cleveland Clinic Florida (Weston, USA).
“Continued innovation is essential due to the complex morphology of mitral valve disease,” said Samir Kapadia, chair, Department of Cardiovascular Medicine, Cleveland Clinic (Cleveland, USA). “The device performed as intended, and we are looking forward to further clinical evaluation of this promising technology.”
The successful compassionate use case follows previous successful implantations of the Subvalvular Spacer in Tashkent, Uzbekistan and Asunción, Paraguay; experience with prior cases has been presented at the Transcatheter Cardiovascular Therapeutics (TCT) conference, the American Association for Thoracic Surgery’s Mitral Conclave, and Miami Valves.
In 2019, Cleveland Clinic Innovations established Mitria Medical as a Cleveland Clinic portfolio company to commercialise the SVS technology. Kapadia and Navia have equity ownership rights as co-inventors of the Subvalvular Spacer.
