OrbusNeich and P&F Products & Features, under the joint partnership OrbusNeich P&F, have announced that the TricValve transcatheter bicaval valves system has received CE mark approval.
The TricValve transcatheter bicaval valve (bioprosthesis) is developed for the treatment of caval reflux present in cases of severe tricuspid regurgitation, without removal of the defective tricuspid valve. The bioprosthesis is available in different diameters for each model (SVC and IVC) and specifically designed to adapt to the anatomic features of the superior and inferior vena cava.
“TricValve is a safe and simple valve system for patients with severe tricuspid regurgitation, said Shaiful Azmi Yahaya, head of the Cardiology Department at the National Heart Institute, Kuala Lumpur, Malaysia. He added: “TricValve provides a new treatment option for patients that are not suitable for surgery, as well as patients with very dilated annulus or very large coaptation gap, or even with a pacemaker.”
“CE mark clearance signifies a new milestone in the structural heart arena. We are pleased to provide a new treatment option to patients with severe tricuspid regurgitation and to those at high risk for open-heart surgery,” said Alain Khair, chief commercial officer of OrbusNeich.
“Receiving CE mark reinforces our joint mission to urgently deliver this technology to patients around the world and we are excited to get started,” added Siegfried Einhellig, president and COO of P&F.