Introduction
The FDA has granted approval for the Selution sustained limus release (SLR) drug-eluting balloon (DEB) to treat coronary in-stent restenosis (ISR), as announced by Cordis. This approval marks an important milestone in the management of coronary artery disease.
Unique Treatment Option
Selution SLR is notable for being the only sirolimus-based DEB available for patients with obstructed or narrowed stented vessels. The device is designed to release sirolimus for up to 90 days without leaving an additional metal layer during percutaneous coronary intervention (PCI).
Patient Impact
Dr. George Adams, Chief Medical Officer of Cordis, highlighted the significance of this approval in alleviating the burden of coronary artery disease and the frequency of repeat procedures that patients and families often face. The Selution SLR DEB provides interventional cardiologists with an effective treatment option while reducing the need for additional stenting, potentially enhancing patient care.
Clinical Evidence
The FDA’s decision was based on the SELUTION4ISR trial, which demonstrated that the Selution SLR DEB was noninferior to standard care options such as drug-eluting stents (DES) and angioplasty in a cohort with ISR. The one-year target lesion failure rate was 15.2% for the Selution group compared to 13.5% for the standard treatment group.
Eligibility Criteria
Candidates for PCI included individuals with target lesions within prior bare metal stents or DES, situated no more than 5 mm from either the proximal or distal edge. The trial excluded patients experiencing ST-segment elevation myocardial infarction or those with more than two previous stent layers, greater than 30% diameter stenosis, or type C lesions after pretreatment.
Comparative Considerations
Although Boston Scientific’s paclitaxel-based Agent DCB was the first in this area to gain FDA approval, its pivotal trial used plain balloon angioplasty as a control, raising questions about direct comparisons to the Selution SLR DEB in terms of safety and efficacy in long-term ISR management.
Ongoing Evaluations
The Agent DCB continues to play a role beyond ISR, as it is being evaluated for treating de novo small vessel or bifurcation coronary artery disease in ongoing trials. The Selution SLR also displayed noninferior efficacy for de novo lesions in coronary arteries with diameters ranging between 2 and 5 mm.
Disclaimer
It is important to consult healthcare professionals for personalized medical advice and treatment options.
Fuente: https://www.medpagetoday.com/cardiology/interventionalcardiology/123087
Join the doctors who get the most relevant medical news, curated by specialty, every week — no spam, unsubscribe anytime.
