“We are very excited to receive a CE Mark for the Alto system, that has been achieved through a strong partnership and collaboration with our European notified body, NSAI,” chief medical officer Matt Thompson said in a news release.
The Alto Abdominal Stent Graft System is an Ovation system for polymer endovascular aneurysm repair. It first received FDA approval in March this year.
“Alto offers a highly differentiated endovascular treatment option to AAA patients and includes design features that we believe will enhance ease-of-use, improve acute outcomes and preserve the long-term durability associated with patient-specific anatomically adaptive sealing,” CEO John Onopchenko said.
“We believe Alto, with its ultra-low profile and 7 mm aortic neck length indication, will provide patients and physicians with an endograft capable of treating the highest proportion of patients within the indications for use of the device,” Onopchenko said in a news release. “As we continue with the global roll-out of the Alto system, which has commenced in the U.S., Endologix is committed to investing in the highest levels of clinical evidence by initiating a head-to-head randomized controlled trial versus traditional undifferentiated EVAR grafts, with the intent of proving the superiority of Alto.”