Boston Scientific Initiates Trial for First Peripheral Vascular Stent with US FDA Breakthrough Device Designation

SAVAL Trial to Assess Treatment for Patients with Critical Limb Ischemia at High Risk of Lower Limb Amputation

MARLBOROUGH, Mass. (September 6, 2018) – Boston Scientific announced it has enrolled the first patient in the SAVAL pivotal trial to evaluate clinical outcomes of the SAVAL™ Below the Knee (BTK) Drug-Eluting Stent System in patients with an advanced stage of peripheral artery disease (PAD) called critical limb ischemia. The SAVAL BTK Stent System is the first CLI device to be recognized by the U.S. Food and Drug Administration (FDA) Breakthrough Device program.

Nearly 17 million people in the U.S. live with some form of PAD with 11 percent of these cases developing into CLI, or a chronic lack of blood supply to the lower legs.[1],[2] Research has shown that within one year of being diagnosed with CLI, 30 percent of patients will have undergone amputation. Arterial blockages below the knee can be challenging to treat effectively with traditional interventional procedures due to arterial recoil, which is the natural tendency of the vessels to maintain their original shape, and the high occurrence rates of calcified lesions.

The SAVAL BTK Stent System is the first stent system designed specifically to address these anomalies with a paclitaxel-polymer combination to facilitate sustained release of an anti-restenotic drug proven to minimize tissue re-growth and vessel recoil, thus reducing the potential for revascularization.

Due to the absence of effective treatment options for patients suffering from CLI, the FDA granted the Expedited Access Pathway (EAP) designation to the SAVAL BTK Stent System. This program is intended to provide patients timely access to medical devices that demonstrate the potential to address unmet clinical needs in treating life threatening or irreversibly debilitating diseases or conditions. In late 2017, EAP devices were transitioned to the FDA's Breakthrough Device program.[3]

“Critical limb ischemia is a serious condition, affecting numerous patients at increasing rates across the globe,” said Dr. Jihad Mustapha, M.D., with the Advanced Cardiac & Vascular Amputation Prevention Centers in Grand Rapids, MI, and global principal investigator of the SAVAL trial. “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.”

The SAVAL trial is a global, prospective, randomized, multicenter trial designed to assess the safety and efficacy of the SAVAL BTK Stent System compared to percutaneous transluminal angioplasty (PTA) in treating patients with CLI. The study will include approximately 200 patients at 50 sites in the U.S., Europe and Japan. First patient enrollment occurred at New Mexico Heart Institute in Albuquerque, New Mexico by Dr. Steve Henao, M.D.

“In our pursuit to address unmet clinical needs, the SAVAL BTK Stent System is a proof point in our long-standing commitment to develop and invest in solutions that improve clinical outcomes, especially in tackling the unique challenges that critical limb ischemia presents,” said Professor Ian Meredith, M.D., executive vice president and global chief medical officer. “As a result of the FDA granting Boston Scientific a breakthrough device designation, we have the opportunity to accelerate our ability to provide clinicians with a comprehensive portfolio of drug-eluting therapies and rotational atherectomy technologies specifically designed for the treatment of peripheral vascular disease.”

As part of the company’s focus on advancing treatment options for patients with lower limb peripheral artery disease, Boston Scientific also recently received FDA-clearance for the SAVION™ family of guidewires which support below-the-knee access during interventional procedures.

The SAVAL BTK Stent System is an investigative device only. It is not approved for use or sale.