TRiCares Announces Successful Implantation of Topaz Transcatheter Tricuspid Valve Replacement System in Europe’s First Case with Pacemaker Patient

Tricuspid Regurgitation (TR) is a common and serious condition, with open-heart surgery and symptomatic medication being the current standard treatment options. Due to the high risk of mortality, open-heart surgery is severely limited and is not considered an option for most TR patients. Topaz is an innovative minimally invasive device specifically designed to assist patients with severe TR without the need for open-heart surgery.

The Topaz device was implanted in a 74-year-old female patient with pacemaker leads passing through the tricuspid annulus, classified as New York Heart Association (NYHA) Class III heart failure. The procedure took less than 30 minutes, with the precise positioning required for valve implantation achieved, reflux reduced to trace levels, and no paravalvular leakage. Importantly, the performance of the pacemaker was not affected by the valve. Two months later, the patient returned for follow-up, confirming the excellent outcomes of the implant.

Successfully implanted at the University Medical Center Mainz in Germany, led by Professor Ralph Stephan von Bardeleben and Professor Hendrik Treede. Tobias Ruf was responsible for ultrasound guidance, with support from Pascal Lim. The procedure was recorded as a live case for the European Association for Cardio-Thoracic Surgery (EACTS) and presented at a medical conference in early October.

To date, a total of 24 implant surgeries have been performed in Europe and Canada.

Professor Ralph Stephan von Bardeleben, Director of the Center for Structural Heart Disease Interventions and Heart Valve Center in Mainz, Germany, commented: "I am very proud to have participated in another successful implantation of the Topaz Tricuspid Valve Replacement System in a patient, especially considering the severity of the patient's condition and the presence of a pacemaker. This innovative solution has the potential to provide a much-needed treatment option for this group of patients who lack effective long-term therapeutic choices."

Professor Hendrik Treede, Director of the Department of Cardiac and Vascular Surgery at Mainz University Hospital, commented: "The implantation of the Topaz valve is very straightforward, and the adaptability of the prosthesis to anatomical conditions has impressed me. The implants in our clinic indicate that patients with pacemakers will also benefit."

TRiCares CEO Helmut Straubinger commented: "The excellent outcomes in the first patients implanted with the pacemaker have driven us to promote the successful use of our Topaz prosthesis among more patients suffering from severe tricuspid regurgitation."

TRiCares, founded in 2013, is a medical device startup headquartered in Paris, France, with another office in Munich, Germany. The team's vision is to bring to market a catheter-based tricuspid valve replacement system that will help patients with severe TR without the need for open-heart surgery.

The technical opinions in this article do not represent the views of CCI.

Planning: Shen Li/Editor: Chen Baolin

Author: Yun Ye Xuan /Production: Wang Rui