Transcatheter Technologies Adds to its Aortic Repair Product Line

Transcatheter Technologies GmbH, an emerging medical device company that develops transcatheter valve implantation systems for catheter-based heart valve therapy, has expanded it product platform to include an endovascular aortic repair (EVAR) device named Tumbao. 

A thoracic or abdominal aortic aneurysm is a dilatation of the aortic vessel that occurs in 2-8 percent of patients older than 50 years. The dilatation presents none or few symptoms until rupture. In patients suffering a ruptured aortic aneurysm, the mortality is up to 80 percent. The most common methods of aortic repair are traditional open surgery and EVAR. In the surgical procedure, the wall of the aneurysm is replaced with a synthetic graft. In the EVAR procedure, a stent graft is inserted percutaneously through the femoral artery into the aneurysm. Unlike surgical aortic repair, recovery after EVAR typically is very fast.

According to officials from Transcatheter Technologies, what makes their platform unique is that it allows for unprecedented precision-controlled expansion and anchoring of self-expanding nitinol stents for the treatment of complex aortic aneurysm. With this proprietary system a stent can be repositioned—or even retrieved—if needed.

“We are expanding our platform technology to comprise not only Trinity TAVI for the treatment of aortic stenosis and Tresillo TMVI for the treatment of mitral valve insufficiency, but also a unique system, Tumbao, for endovascular aortic repair. Tumbao is designed to make aortic stenting more precise and safer,” said Wolfgang Goetz, M.D., Ph.D., CEO. “This coated endovascular stent allows for extraordinarily precise positioning and anchoring, thus making the treatment of more complex aortic disorders possible.

“Additionally, a short version of Tumbao can seal endoleaks between an existing aortic stent and the native aortic wall (endovascular aortic sealing),” said Goetz. “An endoleak is a persisting leak into the aneurysm sac, a common complication of EVAR.”

Earlier this year, the company expanding its product family to include Tresillo, a transcatheter mitral valve implantation (TMVI) version. Tresillo joins the product Trinity, a repositionable transcatheter aortic valve implantation (TAVI) system for transapical and transfemoral implantation.

Approximately 3 percent of the population older than 60 years is suffering from symptomatic mitral valve regurgitation and may benefit from a Transcatheter mitral valve implantation while avoiding open-heart surgery.

The Trinity, Tresillo and Tumbao systems are not approved for sale or investigational use in the United States. At present, Edwards Lifesciences and Medtronic are the only companies with U.S. Food and Drug Administration-approved TAVI technology.