Boston Scientific has launched in European countries the Promus Element Plus BTK (below the knee) Everolimus-Eluting Stent System for the treatment of certain severe peripheral artery lesions. The drug-eluting stent has CE mark approval for both monorail and over-the-wire versions and will be available immediately.
The Promus Element Plus BTK is indicated for the treatment of critical limb ischemia or severe lower leg claudication in infrapopliteal lesions.
In patients with critical limb ischaemia, restoring and maintaining maximum blood flow to the legs is critical to helping reduce the risk of limb amputation. Stand-alone percutaneous transluminal angioplasty (PTA), the current standard for treatment of below-the-knee arterial disease, is often not enough to keep blood vessels open due to complications that can re-occlude the vessel. These complications are often treated with bare metal stents. Several randomised controlled clinical trials have demonstrated that drug-eluting stents have significantly better clinical outcomes than bare metal stents in critical limb ischaemia patients. The prognosis of critical limb ischaemia patients treated with bare metal stents is poor with only 50% of patients remaining alive and free from major amputation one year after the diagnosis is made.
“The drug-eluting stent is an important additional tool that I use to address focal stenosis in the arteries below the knee, and ultimately reduced amputation rates in critical limb ischaemia and claudicant patients,” said Martin Kamarád, Podlesí Hospital in Trinec, Czech Republic. “In addition to the benefits of drug delivery I believe the Promus Element Plus BTK Stent offers significant advantages in terms of properties in the design and higher resistance to compression and less recoil thanks to its unique Platinum-Chromium alloy and stent architecture.”
The Everolimus drug and polymer used on the Promus Element Plus BTK Stent have been studied in multiple coronary randomised clinical trials and registries such as the Promus Platinum clinical programme involving more than 1800 patients with two years follow-up. In addition, the Platinum Chromium alloy, designed specifically for stenting, enables enhanced visibility and excellent conformability together with less recoil and higher radial strength.