XTENT Working to Bring Customizable Drug Eluting Stent Solution to CAD Patients
XTENT Inc.'s Custom NX stent system reportedly allows physicians to customize the length and diameter of the stent at the site of the lesion.
The system features a proprietary modular stent design that consists of multiple 6 mm cobalt chromium segments coated with Biolimus A9 and PLA, a biodegradable drug carrier. The Custom NX delivery system enables separation at each 6 mm segment and allows for the placement of up to 60 mm of stent. The Custom NX DES System has not been approved for sale by any regulatory authority.
Approximately 220 patients with coronary artery disease have been enrolled in three clinical trials of Custom NX, with up to two years of follow-up data available on some of those patients. The three trials, known as CUSTOM I, CUSTOM II and CUSTOM III, have typically enrolled challenging patient populations presenting with complex disease, including long, narrow and multiple lesions.
Earlier this year, XTENT announced positive six-month follow-up data from the CUSTOM III clinical trial, 90-patient prospective study to assess the safety and efficacy of the Custom NX DES system in CAD patients with up to two de novo lesions treatable with up to 60 mm of customizable stent length.
CUSTOM III enrolled a challenging patient population, with 67 percent of the lesions classified as complex B2/C, an average lesion length of 19.8 mm, and an average reference vessel diameter (RVD) of 2.6 mm. The CUSTOM III trial included some of the longest lesion lengths and smallest RVDs compared to previous drug eluting stent trials. Lesion length and RVD are two important indicators of disease complexity.
For the primary endpoint, MACE at 30 days, the rate was 2.2 percent, consisting of two in-hospital non Q-wave myocardial infarctions (MIs). At six-month follow-up the MACE rate for CUSTOM III was 7.8 percent. There were zero deaths, zero Q-wave MIs, two non Q-wave MIs, or 2.2 percent, and five clinically driven target lesion revascularizations, or 5.6 percent. There was one case of early stent thrombosis in the trial and zero late stent thrombosis. The in-stent late loss for CUSTOM III at six-month follow-up was 0.17 mm, the in-stent binary restenosis rate was 4.4 percent, and the neointimal hyperplasia (NIH) volume was 3.8 percent.
The Custom NX DES System has not been approved for sale by any regulatory authority.