Despite a recall on the Powerlink System delivery catheters a few years back, Endologix (Irvine, California) has been on a bit of a roll lately – increasing its financial success and reaching out to a broader patient demographic in the process.
From doubling its first and second quarter revenue from 2006, to retooling efforts surrounding the Powerlink, the company is now reporting that a 60-patient enrollment is complete in its multi-center, non-randomized, controlled investigational device exemption (IDE) clinical trial that is intended to support FDA approval of the large 34 mm diameter Powerlink infrarneral cuff in conjunction with the Powerlink bifurcated stent graft system. Typically a 28 mm diameter infrarneral cuff is the standard size. The addition of the 34 mm is being called an addition and a slight modification, the company said.
The Powerlink System came under fire two years ago. At the time the company said that it initiated a recall as a result of a “comprehensive analysis of three recent reports of tip separation from the catheter sheath inner core during procedures.” In two of the cases, it said, the Powerlink stent graft was successfully deployed and in one case the separation occurred before the device could be positioned for deployment (Medical Device Daily, Dec 16, 2005).
The recall did not include the Powerlink stent grafts that have been implanted in patients, and it does not include the large-diameter 34 mm Powerlink System being evaluated under the IDE or Powerlink Systems sold outside of the U.S.
The Powerlink System is a bifurcated endoluminal stent graft approved by the FDA for the minimally invasive treatment of abdominal aortic aneurysm (AAA). In this trial, a 28 mm Powerlink System bifurcated stent was utilized with a 34 mm proximal cuff to exclude blood flow from the aneurysm in patients with aortic necks up to 32 mm in diameter.
Endologix added the 34 mm diameter after studies showing that 5% to 10% of abdominal aortic aneurysm patients were excluded because of their large aortic neck diameter. The overall patient mortality rate for ruptured AAA is about 75% making it the 13th leading cause of death in the U.S.
“There’s a significant amount of people who aren’t able to be treated so Endologix took a step to create a device,” Paul McCormick, Endologix president/CEO, told Medical Device Daily.
AAA is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement. Once it develops it continues to enlarge, and if left untreated, becomes increasingly susceptible to rupture.
The first patient was reported to have been treated a little more than two years ago, in the ongoing suprarenal clinical trial with the Powerlink 34 mm System, a modification of the company’s FDA-approved Powerlink System (Medical Device Daily, Sept. 29, 2005).
According to the company the initial test patient wasn’t a suitable candidate for effective treatment with any of the commercially available endoluminal stent grafts (ELGs), and because of his condition and age, highly invasive conventional surgery wouldn’t have been a good option.
The new trial allows for patients in the clinical study to be followed for one year — to a primary endpoint analysis, during which time an additional 120 patients may be treated and followed at up to 20 clinical sites under an FDA-approved continued access provision of this protocol.
“Not only are we establishing a reputation for our Powerlink System as the ELG of choice, but for many patients with unfavorable anatomies we believe our technology may uniquely meet their clinical needs that may not be properly addressed with other available ELGs,” McCormick said. “In addition to the estimated 35,000 ELG procedures to be performed in the U.S. this year, almost an equal number of patients still will be referred for open surgery. We believe the Powerlink is a technology that can improve outcomes as well as expand the role for ELGs for many of these patients.”
He added that he expected commercialization of the product within 18 months. The product has already had the CE mark for a year and half.