Israel medical devices firm Valtech Cardio has completed treating first patients with severe mitral regurgitation (MR), using its Transfemoral Cardioband Annuloplasty System.
Avoiding open-heart surgery, the percutaneous annuloplasty device was able to completely treat the first two MR patients at Italy’s San Raffaele Hospital.
Valtech says that the Cardioband system comes with the flexibility to adjust the size while the heart is beating and that it can be implanted without disturbing the patient’s heartbeat and without any need for a cardiac bypass machine for the treatment.
After a short and fully percutaneous procedure performed by Dr. Francesco Maisano, the degree of the mitral regurgitation has come down from severe to mild in both patients.
Valtech said that the patients are in good condition after their discharge in the 48-72 hours subsequent to the intervention and were also found to be doing well after 30 days of follow-up.
"Implanting the Cardioband is a straightforward intervention that can become a routine procedure," said Dr. Maisano, who is due to present the cases in two different conferences at Paris and Canada soon.
San Raffaele Hospital head of the division of cardiology Prof. Antonio Colombo, who led the heart team in carrying out the first treatment, said the system preserves the option for future percutaneous or surgical valve replacement, making it the ideal first-line interventional therapy.
Head of the division of cardiac surgery Prof. Ottavio Alfieri, who jointly led the heart team, commented, "The Cardioband system provides an excellent alternative for patients who are considered at high risk for surgery."
Valtech also said the form and clinical function of the device resembles the annuloplasty rings, which are claimed to be the standard-of-care in surgery.
The company is currently performing a multi-center study in various European centers to evaluate the safety and efficacy of the system in MR patients who desperately require surgery.
Valtech Cardio founder and chief operating officer Amir Gross remarked, "Being able to deliver the surgical gold standard solution, via a transfemoral approach is a major milestone."
"We are very pleased to see these successful outcomes and are now preparing to undertake implantations at major heart centers in Germany and France," Gross added.
Image: The Transfemoral Cardioband Annuloplasty System replaces the need for open-heart surgery for MR patients. Photo: Courtesy of Valtech Cardio Ltd/ PR Newswire.