The Christ Hospital, Lindner Research Center in Cincinnati, USA, has enrolled the first patient in Svelte Medical System’s OPTIMIZE clinical study; the study is designed to further assess the safety and effectiveness of the Svelte drug-eluting stent integrated delivery system and rapid exchange platforms.
The randomised, controlled OPTIMIZE study is expected to enrol approximately 2,000 patients at up to 125 sites in the USA, Japan and Europe in support of USA and Japan regulatory approvals. The Svelte integrated delivery system and rapid exchange platforms systems use low-profile, highly conformable stents and a new class of bioresorbable drug carrier eluting sirolimus. The fixed-wire Svelte integrated delivery system—according to a press release, the world’s lowest profile drug-eluting stent—downsizes catheters to facilitate transradial intervention and direct stenting, extracting steps, time and cost from coronary stent procedures. Both systems hold CE mark certification and are commercially available in Europe.
The press release reports the OPTIMIZE study builds on the positive outcomes previously reported in the DIRECT I and DIRECT II studies. DIRECT I, a first-in-man study evaluating the feasibility of the Svelte stent integrated delivery system, completed five-year follow-up with 0% clinically-driven MACE reported. DIRECT II, a randomised, multicentre study comparing the safety and efficacy of the Svelte stent integrated delivery system with the Medtronic Resolute Integrity drug-eluting stent, reports clinically-driven MACE of 3.7% and 9.8% through three years in the Svelte stent integrated delivery system and control drug-eluting stents arms, respectively. There has been no report of stent thrombosis in the approximately 2,000 patients treated with Svelte drug-eluting systems in clinical and commercial settings.
JD Corl (Christ Hospital, Lindner Research Center in Cincinnati, USA), who treated the first patient in the study, says: “The profile, flexibility and overall deliverability of the Svelte system is remarkable. The added value of a low-compliant delivery balloon to deploy stents at higher pressures, reducing the need for traditional non-compliant post-dilatation balloons, is a real benefit to interventionalists.”
By combining a drug-eluting stent, balloon and wire into a single, low-profile integrated system, the Svelte integrated delivery system has demonstrated the ability to reduce procedure time, contrast use, radiation exposure and adjunctive product use in registry studies overseas. The OPTIMIZE study will assess the safety, efficacy and health economic benefit of the Svelte integrated delivery system and rapid exchange platforms.
“OPTIMIZE will be a landmark study for interventional cardiology. Not only is it evaluating an entirely new approach to coronary stent delivery using 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. Both the OPTIMIZE study and the new technology being evaluated are very exciting,” says Dean Kereiakes (Christ Hospital)—the principal investigator of the OPTIMIZE study.