Harpoon is an investigational beating heart mitral valve repair system designed with a less invasive technique than open heart surgery for treating severe degenerative mitral valve regurgitation, according to a news release.
Irvine, Calif.-based Edwards performed the first procedure in its Restore clinical trial at the University of Maryland Medical Center in Baltimore.
Researchers at the University of Maryland Heart and Vascular Center developed the Harpoon system, which requires a small incision to repair the mitral valve. Procedures using the system are conducted while the heart is still beating, removing the need for a heart bypass machine to mimic the heart and lungs while the heart stopped for surgery.
“Symptomatic patients with severe degenerative mitral valve regurgitation can experience limitations in their day-to-day life ranging from reduced physical activity to more serious complications,” Marcus Chief of cardiovascular surgery for Piedmont Healthcare & national principal investigator for the Restore trial Dr. Vinod Thourani said in the release. “Utilizing less invasive approaches, we can potentially reduce the need for traditional open-heart surgery and the hardships associated with a patient’s healing and recovery process.”
The Restore trial will enroll up to 360 patients in need of mitral valve repair surgery due to severe degenerative mitral valve regurgitation, according to Edwards.
“The Harpoon beating heart mitral valve repair system is a testament to Edwards’ commitment to the research and development of innovative, patient-focused technologies that have the potential to transform cardiac surgery,” added Edwards corporate VP, surgical structural heart Daveen Chopra. “The Restore clinical trial will add to the growing body of evidence for the Harpoon system, which is also being evaluated as part of the Ascend post-market study in Europe.”