First-in-Man Study Using the World’s First Drug-Eluting Stent-on-a-Wire Completes 5-Year follow-up with 0% Major Adverse Cardiac Events; No Additional Revascularizations through 3 Years in DIRECT II Study
PARIS–(BUSINESS WIRE)–May 16, 2017–
Final 5-year outcomes from the DIRECT first-in-man study were presented at the EuroPCR symposium today, with 0% clinically-driven Target Lesion Revascularization (TLR), Target Vessel Failure (TVF) and Major Adverse Cardiac Events (MACE) reported. The DIRECT single-arm study enrolled 30 patients at 4 centers in New Zealand to assess the feasibility of the Svelte drug-eluting coronary stent-on-a-wire Integrated Delivery System (IDS) in patients undergoing percutaneous coronary intervention.
“Longer-term follow-up of novel coronary stents is very important, as shown by the recent findings of unexpectedly high rates of very late thrombosis in bioresorbable scaffolds. The absence of late adverse clinical events through 5 years is unusual in any stent study. Considering half of the lesions treated in DIRECT were type B2/C and 97% device success was achieved despite all investigators being first-time operators with the system, I am very impressed with these results,” said Mark Webster, interventional cardiologist at Auckland City Hospital and Principal Investigator of the DIRECT study.
Positive outcomes were also reported in the DIRECT II study through 3 years. In patients treated with the Svelte IDS, 3-year MACE remained unchanged from 1 year at 3.7%, while in the control arm, MACE increased from 7.8% to 9.8%. Neither arm had reports of stent thrombosis through 3 years.
DIRECT II is a prospective, randomized, multi-center clinical study comparing the safety and efficacy of the Svelte IDS with the Medtronic Resolute Integrity™ drug-eluting coronary stent in 159 patients. Direct stenting was performed in approximately 90% of lesions. Though powered only to demonstrate non-inferiority in 6-month angiographic outcomes between both arms, the DIRECT II study continues to demonstrate numerical superiority of the Svelte IDS arm compared with the control arm in all clinical outcomes through 3-years. The Svelte arm further exhibited reduced procedure and device times, with trends toward reduced fluoroscopy time and contrast use compared with the control arm, confirming results observed in prior studies utilizing the Svelte IDS.
“The long-term results observed in the DIRECT and DIRECT II studies, coupled with no reports of stent thrombosis now through 5-years, indicate our technologies provide excellent and sustained patient outcomes,” said Jack Darby, President and CEO of Svelte Medical Systems. “Our unique approach to stent delivery and bio-friendly drug coating allow physicians to streamline PCI and achieve best-in-class results, delivering both clinical and economic value to the healthcare system. We look forward to serving more patients and physicians around the globe.”
Svelte is working with the FDA and PMDA to obtain regulatory approvals for clinical evaluations of its DES technologies in the US and Japan, and plans to initiate a clinical study during the second half of 2017. The IDS, incorporating Asahi ACT ONE™ wire technology and a proprietary low-compliant delivery balloon, is commercially available in select accounts in Europe as SLENDER IDS. Svelte has additionally developed a rapid-exchange system (DIRECT RX) using the same proprietary DES and balloon technologies, which attained CE Mark certification last year.
About Svelte Medical Systems
Headquartered in New Providence, New Jersey, Svelte Medical Systems (www.sveltemedical.com) is a privately-held company engaged in the development of highly deliverable balloon expandable stents. Statements made in this press release that look forward in time or that express beliefs, expectations or hopes regarding future occurrences or anticipated outcomes or benefits, are forward-looking statements. A number of risks and uncertainties, such as risks associated with product development and commercialization efforts, results of clinical trials, ultimate clinical outcomes and benefit of the company’s products to patients, market and physician acceptance of the products, intellectual property protection and competitive product offerings, could cause actual events to adversely differ from the expectations indicated in these forward looking statements.
Svelte Medical Systems, Inc.
Jack Darby, 908-264-2012
President and CEO