Aptus Endosystems has announced it has completed primary enrollment in the STAPLE-2 Pivotal Study of the Aptus Endovascular AAA Repair System. The study will assess the safety and effectiveness of the Aptus.
“Having been involved with clinical trials for EVAR since the early days of the EVT endograft, the completion of the pivotal STAPLE-2 study brings the therapy to a new level. This truly novel concept of active proximal fixation using helical ‘screws’ combined with a modular endograft on a very small, flexible delivery system expands the option for endovascular therapy to a greater pool of patients. The one year follow-up outcome data is particularly robust and impressive,” said Dr Ronald Fairman, University of Pennsylvania, and co-national Principal Investigator for the STAPLE-2 study.
One hundred fifty-five patients were successfully enrolled across 25 US clinical trial sites as part of the study to assess the peri-operative and long term performance of the company’s unique and proprietary combination of stent graft and endovascular stapling system in the treatment of abdominal aortic aneurysms. Patients enrolled in the study are subject to a 1, 6 and 12 month follow-up review, subsequent to which the company will submit data to the FDA for review under the pre-market approval process. The company intends to submit its final data module to the FDA early next year.
“This endovascular stapling technology facilitates our ability to perform aneurysm repair in a manner that closely approximates the suturing technique that is the foundation of open surgical repair. Having the ability to separately control the fixation of the endograft in a catheter-based technology is a new and clinically important capability relative to improved outcomes for patients,” added Dr Manish Mehta, Albany Medical Center, Albany, NY, and co-national Principal Investigator.
In the company’s phase I study (STAPLE-1) 21 patients were enrolled at five US institutions, Aptus’ unique endograft design, enabled by the use of its proprietary endovascular stapling system, has produced exceedingly positive clinical outcomes. These study results demonstrated that patients experienced no device-related endoleaks (Type I, III or IV) and no device migration as late as two years post-procedure for those patients who had reached that follow-up. Additionally, over 90% of patients demonstrated a clinically significant reduction in their aneurysm size as early as six months post-procedure.