Pivotal Trial Begins for Boston Scientific's Saval BTK DES to Treat CLI
September 6, 2018—Boston Scientific Corporation announced that it has enrolled the first patient in the SAVAL pivotal trial to evaluate clinical outcomes of the company's Saval below-the-knee (BTK) drug-eluting stent (DES) system in patients with critical limb ischemia (CLI).
The global, prospective, randomized, multicenter SAVAL trial is designed to assess the safety and efficacy of the Saval BTK stent system compared to percutaneous transluminal angioplasty in treating patients with CLI. The study will include approximately 200 patients at 50 sites in the United States, Europe, and Japan.
The Saval BTK stent system is specifically designed to address the anomalies of BTK arterial blockages including arterial recoil and the high occurrence rates of calcified lesions. The device's paclitaxel-polymer combination facilitates sustained release of the antirestenotic drug.
Jihad Mustapha, MD, who serves as Global Principal Investigator of the SAVAL trial, commented in the announcement, “CLI is a serious condition, affecting numerous patients at increasing rates across the globe. The commencement of the SAVAL trial signals the advancement of endovascular techniques featuring the latest in drug-eluting stent technology, with the potential to drastically improve the quality of life for patients who live in fear of losing their legs due to CLI.” Dr. Mustapha is with the Advanced Cardiac & Vascular Amputation Prevention Centers in Grand Rapids, Michigan.
Currently, the Saval BTK stent system is an investigational device only and is not approved for use or sale.
The company noted that the Saval BTK DES system has been recognized by the FDA Breakthrough Device program because of the absence of effective treatment options for patients with CLI. The FDA first granted the Expedited Access Pathway (EAP) designation to the device. In late 2017, EAP devices were transitioned to the FDA's Breakthrough Device program.