US-based stents developer Svelte Medical Systems has started patient enrolment in the OPTIMIZE clinical study of its drug-eluting stent (DES) Integrated Delivery System (IDS) and Rapid Exchange (RX) platforms.
Svelte IDS is a fixed-wire DES designed to downsize catheters to allow transradial intervention (TRI) and direct stenting, eliminating steps, time, and cost associated with coronary stent procedures.
Both the CE-Marked IDS and RX systems employ low-profile, conformable stents, and new bioresorbable drug carrier eluting sirolimus.
The randomised, controlled OPTIMIZE study will evaluate the safety and effectiveness of the DES platforms, and the results are expected to support their approval for atherosclerotic coronary lesion treatment in the US and Japan.
While the study is set to recruit around 2,000 subjects at up to 125 centres in the US, Japan, and Europe, the first patient was enrolled at the Christ Hospital, Lindner Research Center in Ohio, US.
OPTIMIZE study principal investigator Dean Kereiakes said: “OPTIMIZE will be a landmark study for interventional cardiology.
“Not only is it evaluating an entirely new approach to coronary stent delivery utilising novel concepts and next-generation technologies, OPTIMIZE is the first trial to evaluate, in a prospective, randomised fashion, direct stenting as well as the potential health economic impact derived by streamlining PCI.”
The study is based on prior positive data reported from the DIRECT I and DIRECT II studies that assessed the Svelte IDS’ feasibility, safety, and efficacy, respectively.
Svelte Medical Systems president and CEO Jack Darby said: “Our highly differentiated platforms improve procedural efficiency and reduce cost while enhancing patient outcomes and comfort, delivering value to all constituents involved in coronary stenting – patients, physicians, providers and payers.”