The first patient has been enrolled in the SAVAL pivotal trial to evaluate clinical outcomes of the SAVAL below-the-knee (BTK) drug-eluting stent system (Boston Scientific) in patients with critical limb ischaemia (CLI). The SAVAL BTK stent system is the first CLI device to be recognised by the US Food and Drug Administration (FDA) Breakthrough Device programme.
Nearly 17 million people in the USA live with some form of peripheral arterial disease with 11% of these cases developing into CLI. Research has shown that within one year of being diagnosed with CLI, 30% 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.
According to Boston Scientific, 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 minimise tissue re-growth and vessel recoil, thus reducing the potential for revascularisation.
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 programme 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 programme.
“Critical limb ischaemia is a serious condition, affecting numerous patients at increasing rates across the globe,” said Jihad Mustapha, with the Advanced Cardiac & Vascular Amputation Prevention Centers in Grand Rapids, USA, 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, randomised, multicentre 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 USA, Europe and Japan. First patient enrolment occurred at New Mexico Heart Institute in Albuquerque, USA by Steve Henao.
The SAVAL BTK stent system is an investigative device only. It is not approved for use or sale.