New Jersey device outfit Svelte Medical Systems finished enrolling patients in a pivotal study of its Integrated Delivery System (IDS) drug-eluting coronary stent, comparing it with Medtronic's ($MDT) Resolute Integrity drug-eluting stent.
Svelte enrolled 159 patients total for the DIRECT II study. In the previous trial, DIRECT I, a first-in-man in 30 patients in New Zealand, the stent showed in-stent volume obstruction of 2.7% in 6 months, overcoming drug-eluting stents currently on the market by as much as half.
The IDS delivers the drug sirolimus with a direct stenting approach, meaning the lesion is not widened beforehand and remains tight as the stent is pushed through the blood vessel. According to the company, the novelty of the stent lies in its bioabsorbable amino acid coating, which decreases inflammation up to 5 times more than current coating materials.
Late last month, Svelte pulled in $22 million to help finish the DIRECT II study, bringing its total funding to $65 million overall. With successful results, the company hopes to gain a CE mark for the stent by late 2014 or 2015. For FDA approval, the company will need to conduct another trial, according to FDA News. Svelte received a CE mark for its bare-metal Acrobat stent in 2010.
"Our IDS and RX systems are uniquely designed to facilitate use of the trans-radial and direct stenting approach to PCI, two segments of the market which are not currently served by dedicated technologies, yet have demonstrated significant clinical benefits and procedural efficiencies which are critical in today's healthcare landscape," Svelte's CEO Jack Darby said in a statement.
Svelte has drug-eluting stent competition from some of the bigger med tech players, including Medtronic ($MDT), Boston Scientific ($BSX) and Abbott ($ABT), but the stent arena is also crowded with controversy over whether stents are overused. According to the FDA News report, though, the company's strategy is to penetrate and "own" the approximately $2.5 billion transradial and direct stenting markets over time.
- here's the release
- and here's the FDA News report