Endologix will file data with FDA on the first 10 Powerlink AAA endografts implanted by each physician trained on the device, under conditions of its PMA approval.

In a Nov. 1 release announcing the approval, Endologix characterizes the condition as partly fulfilling "standard continued postmarketing surveillance and annual update reports to the FDA and physician users."

The Powerlink system is a PTFE-covered, cobalt chromium stent-graft indicated for minimally invasive treatment of abdominal aortic aneurysms.

The Irvine, Calif. firm immediately will start selling the system through six to eight reps in select U.S. regions. Within 12-24 months, however, Endologix plans to add 30-40 reps to cover the entire domestic market.

The firm does not foresee any reimbursement issues constraining the market for the device, which costs $10,000 to $12,000.

Through a partnership with Edwards Lifesciences and several distributors, Powerlink has been marketed in Europe since May. The device earned a CE mark in 1999.

Powerlink will be marketed only to physicians trained by the company on proper AAA patient selection and implantation techniques. FDA has approved the company's training program.

The company has not yet projected 2005 Powerlink sales, but estimates that 15,000-20,000 patients are treated with endografts each year and about 36,000 of patients who undergo open aorta surgery over the same period could be treated with an endograft instead.

Therefore, the annual U.S. endograft market is currently worth an estimated $200 mil. and may reach $800 mil. by 2008, according to Endologix.

The endograft gained U.S. approval on the strength of Endologix' 258-patient pivotal trial data, submitted in January. The randomized study showed that AAA treatment with Powerlink is associated with significantly lower 30-day mortality than standard open surgical repair (1.04% vs. 6.06%), even though Powerlink patients in the trial were older, on average, than the surgical group.

The trial also showed that hospital stays, operative and ICU time were shorter with Powerlink compared with surgery, and blood loss was significantly lower with the endovascular device.

After 24 months, the aneurysm sack shrunk or remained stable in 64% and 35% of Powerlink patients, respectively.

Powerlink was successfully deployed in 98% of patients, according to Endologix. The stent-graft was associated with "negligible" migration, endoleak, rupture, fracture and other material failure during the follow-up period - problems that have plagued other AAA endografts in the past, the company emphasizes.

"A number of large medical device companies have stumbled and failed with their [AAA endograft] efforts," Endologix President & CEO Paul McCormick states. "This is a significant opportunity and we will learn from their mistakes."

The company touts Powerlink's one-piece bifurcated design as a solution to many of the implantation complexities and limb detachment problems associated with multi-piece bifurcated systems.

Endologix also maintains that the one-piece cobalt-chromium cage is less prone to kinking than competing devices and therefore more suited to tortuous anatomy. The company is considering pursuing additional labeling language that would indicate Powerlink for highly angulated vessels.

The Powerlink results are supported by the 345-patient, randomized DREAM study, recently published in the New England Journal of Medicine. Led by Monique Prinssen, MD, et al., University Medical Center, Utrecht, The Netherlands, DREAM showed a 30-day mortality rate of 1.2% in the endovascular repair group versus 4.6% for open surgical repair (¹ Also see "AAA Endografts “Preferable” To Open Repair – DREAM Study" - Medtech Insight, 18 October, 2004., p. 18).

Medtronic ( AneuRx ), W.L. Gore ( Excluder ) and Cook ( Zenith ) currently market AAA endografts, but Guidant ( Ancure ) and Edwards ( LifePath ) have dropped out of the sector within the last two years.

Both companies cited the fracture-related adverse events that surrounded first-generation AAA endografts as a factor curbing demand for their devices (² 'The Gray Sheet' April 12, 2004, In Brief).

AE Rates For Powerlink AAA Graft Lower Than For Predecessors – Endologix

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