On 25 April, Boston Scientific announced Health Canada approval and market launch of the Promus Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System in Canada for the treatment of patients with coronary artery disease.
The first patient implant in Canada using the new device was recently performed by Philippe L’Allier, Cath Lab director, Montreal Heart Institute. He said: “The unique PtCr alloy and stent architecture of the Promus Element Stent offer significant advantages in conformability, radial strength and visibility compared to other stent platforms.”
“The best-in-class deliverability of the Promus Element Plus Stent System will help in accessing challenging lesions,” said L’Allier.
The Promus Element stent, part of the Promus Element Stent System and the Promus Element Plus Stent System, uses a proprietary PtCr alloy designed specifically for coronary stenting, which enables enhanced visibility, less recoil, excellent conformability and higher radial strength. The Promus Element Plus Stent System employs an advanced low-profile delivery system featuring a dual-layer balloon designed to enable precise stent delivery across challenging lesions and reduce balloon growth during inflation to facilitate high-pressure stent deployment. The everolimus drug and fluorinated copolymer used on this technology have been studied in multiple randomised clinical trials and ‘real-world’ registries, demonstrating excellent long-term safety and efficacy.
“We are pleased to introduce the Promus Element Plus Stent System to physicians and patients in Canada,” said Kevin Ballinger, president, Interventional Cardiology Division, Boston Scientific. “This advanced stent is supported by strong clinical outcomes from the PLATINUM trial, which demonstrated very low rates of revascularisation and stent thrombosis at one and two years.”
In the USA, the Promus Element Plus Stent System was approved by the FDA in 2011.