NEW PROVIDENCE, N.J.–(BUSINESS WIRE)–October 31, 2016–
Svelte Medical Systems, Inc. today announced the start of enrollment in the DIRECT III post-market registry study. DIRECT III is an ‘all-comer’ study in Europe undertaken to evaluate the procedural efficiency and long-term safety of SLENDER IDS, the first advance in stent delivery since the rapid-exchange catheter. SLENDER IDS is the world’s lowest profile drug-eluting stent (DES), reducing the catheter size necessary to perform percutaneous coronary intervention (PCI) and facilitating transradial intervention (TRI) in more patients. Incorporating Asahi guide wire technology, a specialized balloon design and DISCREETTM, a new class of bioresorbable drug coating, SLENDER IDS is designed to enhance direct stenting, enabling interventional cardiologists to extract steps, time and cost from stenting procedures.
“SLENDER IDS is a new approach to coronary stenting, offering unique capabilities which I have integrated into my regular practice to benefit patients,” said Giovanni Amoroso, MD, PhD, Principal Investigator of the DIRECT III study and practicing interventional cardiologist at Onze Lieve Vrouwe Gasthuis (OLVG Hospital) in Amsterdam, The Netherlands. “Vessel trauma with TRI is always a concern, especially in the elderly and patients of smaller stature. The ultra-low profile of SLENDER IDS allows me to downsize catheters without compromise to back-up support and performance, making for more slender and streamlined interventions, and ultimately, happier patients.”
DIRECT III will enroll up to 1,000 patients in 6 countries. Access site size, bleeding complications, overall procedure and fluoroscopy time, contrast administration and adjunctive product use will be assessed in all patients, while the first 250 patients will additionally receive clinical follow-up through 1 year. DIRECT III follows upon findings from the DIRECT II randomized, controlled study and previously published registry studies using a bare-metal version of the IDS in which reductions in procedure time, fluoroscopy exposure, contrast administration and material use were observed.
The DIRECT I and II clinical studies have demonstrated exceptionally low clinical event rates, with no deaths or stent thromboses reported through 4 years. SLENDER IDS is indicated for use with direct stenting and in diabetic patients, and is commercially available in Europe. Both SLENDER IDS and DIRECT RX, a rapid-exchange platform designed for direct stenting and utilizing the same DES and balloon technology, will be evaluated next year in the OPTIMIZE study in support of PMA and PMDA approvals.
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.