Mustapha: Taking the ELUVIA DES Technology BTK

August 11, 2021 — Course Director Jihad A. Mustapha, MD, from Advanced Cardiac & Vascular Centers for Amputation Prevention (Grand Rapids, MI) and Michigan State University (East Lansing, MI) presented a talk at AMP 2021 on the the use of the ELUVIA drug-eluting stent (DES) below-the-knee (BTK) and the SAVAL Pivotal Trial.

He emphasized upfront the importance of accurately sizing the stent prior to implantation BTK, suggesting the ultrasound or intravascular ultrasound must be used in every BTK trial to measure the true target lumen before the final therapy is delivered.

“It has been shown recently that just a 5% loss of circumferential luminal gain is equivalent to about a 20% reduction in flow,” said Dr. Mustapha.

Accurate sizing is also important to prevent drug embolization. “If you inflate a drug-eluding balloon or you deploy a stent that has drugs on it, the alluding of the drug would not be primarily from the balloon or the stent into the vessel wall [if the sizing is incorrect],” said Mustapha.

Also, ultrasound allows for proper visualization of the calcium distribution and proper vessel prep prior to DCB inflation.

The SAVAL BTK stent system is a differentiated technology and the first peripheral device selected for Expedited Access Pathway (EAP) designation by the FDA. The stent is a laser-cut, self-expanding nitinol stent coated with an inner PBMA primary layer and an outer paclitaxel/PVDF-HFP active layer.

The SAVAL Pivotal Trial is a randomized trial comparing the SAVAL BTK DES stent system (Boston Scientific) in patients with critical limb ischemia (CLI).

Phase A of the trial has completed enrollment, with 201 subjects with Rutherford Class 4 and 5 CLI, enrolled and randomized (2:1) to SAVAL versus standard percutaneous transluminal angioplasty (PTA). The trial is being conducted at 41 study centers in the US, Europe, and Japan.

The first phase of the trial is designed to provide level 1 evidence of the safety and effectiveness of SAVAL, a DES specifically intended for infrapopliteal applications. Estimated primary study completion is September 2021, according to clinicaltrials.gov.

The second phase of the SAVAL trial, Phase B, is a nonrandomized, single-arm study of 100 patients treated with the SAVAL DES BTK. Enrollment for this phase has commenced, said Dr. Mustapha.
 

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