- Endologix announced Monday it received an FDA panel track premarket approval for its Alto abdominal stent graft. The device maker said it expects better short-term outcomes with Alto, compared to its older generation Ovation iX platform, due to design and manufacturing changes in the new device.
- Endologix also said it will be updating a 2018 safety communication for Ovation iX, which will remain commercially available before the Alto launch.
- Data from the Elevate investigational device exemption (IDE) clinical study supported the company's PMA. A post-approval imaging study is also planned that will focus on consistency in device selection between the company's imaging services and those of implanting physicians in the first 100 patients treated with the system after launch, Endologix said.
Irvine, California-based Endologix has been battered by a series of setbacks involving blood leaks in earlier versions of its abdominal aortic aneurysm (AAA) graft devices. It was forced to recall its AFX with Strata endovascular AAA systems in October 2018 due to increased risk of the problem leading to aneurysm ruptures in patients, compared to similar devices on the market. Medtronic, Cook and Gore are among the manufacturers that make AAA graft products.
A year later, FDA warned patients and healthcare providers in a safety communication of a heightened risk of blood leaks with the company's AFX with Duraply and AFX2 graft systems. An AAA is a weakening of the wall of the aorta that causes a balloon-like enlargement vulnerable to rupture. Leaks typically don't have symptoms and they can lead to rupture and ultimately serious injury or death if left untreated.
Endovascular grafting, a minimally invasive procedure in which a stent graft is delivered to the site of the aneurysm and fastened into place, is increasingly being used to repair the condition instead of open surgery. The graft diverts blood flow away from the aneurysm to relieve pressure on the weakened section of the vessel.
For Endologix, much is riding on a successful launch of its new graft. The company in a February investor presentation said it was working to "purposefully rebuild our reputation" by demonstrating accountability and transparency. It said it had returned to growth after 11 quarters of decline and the completion of a U.S. and EU restructuring.
The company is positioning the Alto system as a differentiated endovascular aneurysm repair (EVAR) device, designed with patient-specific sealing and features aimed at making it easier for the surgeon to implant. "We are committed to proving the superiority of this product over traditional undifferentiated EVAR grafts in a randomized clinical trial," CEO John Onopchenko said in a statement.
The company plans to roll out the Alto device initially to its high-volume customers currently using its iX system before expanding to lower-volume iX customers that are in high-volume centers, Onopchenko said on an earnings call in February.
Analysts at Stifel are optimistic about the device, noting in a new research report that the Alto platform is the company's first new product clearance in the past several years. "In our view, today’s approval is a major positive development and represents the next critical step towards driving sustainable -- if not accelerating -- positive (worldwide) revenue growth," they wrote.
Endologix is assessing the potential impact of the coronavirus pandemic on AAA procedure volumes, the Stifel analysts reported after speaking with management. The analysts said procedures could be delayed for some weeks or months but most likely still would be performed in 2020.