Endologix recently announced that it has received a CE mark for the Alto abdominal stent graft system.
“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 ” commented Matt Thompson, chief medical officer of Endologix. “Alto will provide our physician partners and patients in the EU with a differentiated low profile endovascular treatment option designed to improve durability over traditional EVAR. In addition, with Alto, we anticipate observing improved short-term outcomes relative to the Ovation iX abdominal stent graft system (Ovation iX) as a result of the design and manufacturing changes incorporated into Alto. Lastly, CE mark of the Alto system is yet another critical milestone for Endologix as we seek to introduce a portfolio of devices to address the current unmet needs of endovascular aneurysm repair (EVAR).”
“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,” commented John Onopchenko, chief executive Officer of Endologix.
“We believe Alto, with its ultra-low profile and 7mm 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. As we continue with the global roll-out of the Alto system, which has commenced in the USA, Endologix is committed to investing in the highest levels of clinical evidence by initiating a head-to-head randomised controlled trial versus traditional undifferentiated EVAR grafts, with the intent of proving the superiority of Alto. Finally, with our recent announcement regarding our proposed transition to a private company, we are poised to meet the needs of our customers and the patients we proudly serve and fulfil our company mission.”