Endovascular Today announced the recent completion of the Aptus II study primary enrollment.This is the US study to demonstate safety and effectiveness of the Aptus stapling system from Aptus Endosystems, Inc (Sunnyvale, CA). The device is an aortic endograft system that incorporates the companies proprietary stapling system.
This device will cross another hurdle that has been a long standing differentiating feature of open versus EVAR. Stable proximal fixation, especially in adverse proximal aortic neck anatomy.
The investigators enrolled 155 sequential patients across 25 US clinical trial sites as part of the study to assess the perioperative and long-term performance of the company's combination of stent graft and endovascular stapling system in the treatment of AAA. Patients enrolled in the study are subject to 1-, 6-, and 12-month follow-up reviews. The company will then submit data to the Food and Drug Administration (FDA) for review under the premarket approval process. The company intends to submit its final data module to the FDA early next year. Ronald Fairman, MD, and Manish Mehta, MD, are national coprincipal investigators for the STAPLE-2 study.
The company stated that STAPLE-1, the phase 1 study that enrolled 21 patients at five US institutions, produced positive clinical outcomes, which were presented in November 2008 at the VEITH Symposium in New York City. These study results showed no device-related endoleaks (type I, III, or IV) and no device migration as late as 2 years postprocedure for those patients who had reached that follow-up. Additionally, more than 90% of patients demonstrated a clinically significant reduction in their aneurysm size as early as 6 months postprocedure.
"The 1-year follow-up outcome data is particularly robust and impressive," commented Dr. Fairman. "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 Ôscrews' combined with a modular endograft on a very small, flexible delivery system expands the option for endovascular therapy to a greater pool of patients."
"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," added Dr. Mehta. "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."
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