The two DES systems include SLENDER IDS, an integrated delivery system and DIRECT RX, a rapid-exchange delivery system
The DES systems will treat coronary artery disease. (Credit: Ignacio DG from Pixabay.)
Svelte Medical Systems has received the US Food and Drug Administration (FDA) approval for two of its bioresorbable drug-eluting stent (DES) systems to treat coronary artery disease.
The two DES systems approved by the FDA include SLENDER IDS and DIRECT RX, and both leverage the same specialised stent.
SLENDER IDS is an integrated delivery system that features Asahi guide wire technology, while DIRECT RX is a rapid-exchange delivery system.
The two low profile DES systems are intended to enhance trans-radial intervention (TRI) and are indicated by the US regulator for use with direct stenting.
Svelte Medical Systems president and CEO Jack Darby said: “OPTIMIZE was a unique study – the first of its kind to evaluate a new mode of DES delivery, a new class of drug coating, direct stenting and TRI.
“This not only generated outstanding data on investigational device performance, but also helped identify discrepancies between study definitions and assessments of myocardial infarction in clinical studies, which will help areas of future clinical research.”
The two bioresorbable DCB systems were assessed in the OPTIMIZE investigational device exemption (IDE) trial.
In the study, 30% of the subjects were subjected to direct stenting and 80% treated using TRI, where the devices resulted in 96% success rates.
Also, the systems achieved a Target Lesion Revascularization (TLR) of 1.5% after one year, which is the lowest reported TLR with any investigational DES.
The systems showed strong procedural and clinical outcomes, in addition to reductions in radiation exposure, along with procedure, device and fluoroscopy times.
OPTIMIZE study co-principal investigator Dean Kereiakes said: “SLENDER IDS and DIRECT RX are extremely low profile, highly deliverable DES systems that provide excellent early and long-term clinical outcomes in complex patient populations.
“SLENDER IDS uses a unique DES delivery platform while both systems incorporate a novel drug carrier and other technologies which I believe will add value in the treatment of patients in the US.”