Svelte Medical Systems has commenced enrollment in the DIRECT III post-market registry study, which will assess the procedural efficiency and long-term safety of Slender IDS drug-eluting stent (DES).
Claimed to be the world’s first drug-eluting coronary stent-on-a-wire integrated delivery system (IDS), the Slender has been developed to carry out percutaneous coronary intervention (PCI) and facilitate transradial intervention (TRI) procedures in patients.
The device has been designed to enhance direct stenting and enable interventional cardiologists to extract steps, time and cost from stenting procedures.
In the trial, the company will recruit around 1,000 patients in six countries. The first 250 patients will additionally receive clinical follow-up through one year.
The study will include the assessment of access site size, bleeding complications, overall procedure and fluoroscopy time, contrast administration and adjunctive product use in all patients.
DIRECT III study principal investigator Giovanni Amoroso said: “Slender IDS is a new approach to coronary stenting, offering unique capabilities which I have integrated into my regular practice to benefit patients.
“Vessel trauma with TRI is always a concern, especially in the elderly and patients of smaller stature.”
According to the company, the DIRECT I and II clinical studies have showed low clinical event rates, with no deaths or stent thromboses reported through four years.
Commercially available in Europe, Slender IDS is indicated for use with direct stenting and in diabetic patients.
Next year, Slender IDS and Direct RX rapid-exchange platform designed for direct stenting will be assessed in the OPTIMIZE study in support of PMA and PMDA app.