Terumo Heart, a wholly owned subsidiary of Terumo Corp, has submitted destination therapy (DT) investigational device exemption (IDE) to the FDA for its DuraHeart Left-Ventricular Assist System (LVAS), as part of the process of obtaining approval to begin DuraHeart DT Clinical Trial in the US.
The IDE submission follows the company’s recent FDA notification granting unconditional status on the US DuraHeart Bridge-to-Transplant (BTT) clinical trial, which is currently enrolling patients.
Terumo Heart said that the DuraHeart LVAS is the latest-generation rotary blood pump designed for long-term patient support. The system incorporates a centrifugal flow rotary pump with an active magnetically levitated impeller featuring three position sensors and magnetic coils that optimize blood flow.
The impeller’s magnetic levitation is designed to eliminate friction by allowing a wide gap between blood contacting surface areas, enabling blood to flow through the pump unimpeded in a smooth non-turbulent fashion.
The DuraHeart LVAS is currently being studied in the DuraHeart Pivotal US Trial for Bridge-to-Transplant, a multi-center, prospective, non-randomized study, involving 140 patients. The study will evaluate the safety and efficacy of the device in helping to sustain patients awaiting heart transplant who are at risk of death due to end-stage heart failure.
The DuraHeart LVAS carries a CE mark and is currently available for sale in European countries. Additionally, the company has completed clinical trial enrollment for this device in Japan.
William Pinon, president and CEO of Terumo Heart, said: “Our destination therapy submission represents an important advance in our DuraHeart clinical program, one based on our confidence in its clinical benefit and with the ongoing support of Terumo Corporation. There is a significant need and opportunity to serve advanced-stage heart failure patients who are not eligible for transplant.
“With our recent FDA notification of unconditional approval status for our DuraHeart BTT trial, we anticipate further expansion of our clinical sites and acceleration of patient enrollment.”