DIRECT II Supports Svelte Medical's DES Integrated Delivery System

September 18, 2014—Svelte Medical Systems announced that its drug-eluting coronary stent’s integrated delivery system (IDS) for percutaneous coronary intervention (PCI) met all 6-month angiographic and clinical endpoints in the DIRECT II study. The IDS also exhibited reduced procedure and device times, with trends toward reduced fluoroscopy time and contrast use, confirming results seen in previous studies in which the IDS demonstrated procedural time and cost savings.

Data from the DIRECT II study were presented at the 26th Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC. In November 2013, the company announced completion of enrollment in DIRECT II and noted that interim data were presented at the 25th Transcatheter Cardiovascular Therapeutics scientific symposium in San Francisco, California.

According to Svelte Medical, DIRECT II is a prospective, randomized, multicenter clinical study comparing the safety and efficacy of the Svelte drug-eluting coronary stent IDS versus the Resolute Integrity drug-eluting coronary stent (Medtronic, Inc.) in 159 patients. The study was conducted in support of European CE Mark approval of the Svelte system.

The company reported that the DIRECT II results established noninferiority to Resolute Integrity device in the primary efficacy endpoint of in-stent late lumen loss at 6 months (0.09 ± 0.31 mm vs 0.13 ± 0.27 mm; P for noninferiority < .0001). Clinical outcomes were similarly positive, with 6-month target lesion revascularization (TLR), target lesion failure, target vessel failure, myocardial infarction, and major adverse cardiac event rates in the Svelte IDS arm half those observed in the Resolute Integrity arm. At 6 months, the TLR rate with the Svelte IDS was 0.9%, affirming results seen in the direct first-in-man study in which 0% TLR and major adverse cardiac event rates are now sustained through 28 months.

In Svelte Medical’s press release, Stefan Verheye, MD, commented, “The results of the DIRECT II study confirm the safety and effectiveness of this interesting new concept for coronary artery stenting. The Svelte IDS can be delivered through smaller catheters and facilitates radial artery access, two increasingly important approaches to PCI demonstrating improved procedural outcomes and greater patient comfort.” Dr. Verheye is Co-Director of the Antwerp Cardiovascular Institute at the Middelheim Hospital in Antwerp, Belgium.

The Svelte IDS utilizes an integrated wire design that provides a low crimped stent profile. It is designed to optimize transradial interventions (TRIs) and a “slender” approach to PCI by downsizing catheter sizes used during intervention. The company noted that TRI is used in the majority of PCIs in Japan and parts of Europe, and its use in the United States is rapidly growing, increasing from < 5% of procedures in 2007 to 25% today. In the DIRECT II study, 67% of patients were treated via TRI.

Both the IDS and a conventional rapid-exchange platform incorporating the company’s balloon control band technology will be offered with the Svelte drug-eluting stent and are expected to be commercially available in Europe in 2015, advised Svelte Medical.