Endologix has the received a Conditional Approval Letter from the US Food and Drug Administration (FDA), allowing the commercial distribution of the company's Powerlink system, an endoluminal stent graft (ELG) for the minimally invasive treatment of abdominal aortic aneurysms (AAA). The conditions of approval require the standard continued post-marketing surveillance and annual update reports to the FDA and physician users.
"This is an eventful day for people with AAA and their physicians, as well as for the employees and shareholders of Endologix," said Paul McCormick, President and CEO. "Use of ELGs allow patients to avoid invasive surgery that carries well-documented high rates of morbidity and mortality by opting for a minimally invasive procedure. US patients with AAA will have access to our ELG that addresses many shortcomings of devices currently on the market."
Regulatory process and clinical results
US Conditional marketing approval for the Powerlink system was granted based on FDA review of the pre-market approval (PMA) application Endologix filed in January 2004. This marked the final step in a modular submission process that included results of Endologix's pivotal clinical trial with the Powerlink System.
The pivotal trial included 192 test patients and 66 controls treated by conventional open surgery. Trial highlights include:
NPowerlink System was successfully deployed in 97.9% of test patients.
The study demonstrated a significantly lower mortality rate for the Powerlink patients versus open surgery during the 30-day post operative period, 1.04% versus 6.06%. This, in spite of the mean age of the Powerlink System patients being significantly older.
Mean length of hospital stay was 3.3 days for the Powerlink patients versus 9.5 days for the surgical control patients.
Operative time, blood loss, and ICU stay for Powerlink System patients were significantly lower versus control patients.
33% of the Powerlink patients were treated using a regional or local anesthesia.
During the follow-up period there was negligible device migration, low endoleak rate, and no reported AAA ruptures, wire form fractures or material failures of the Powerlink System.
Core lab analysis at 24 months demonstrated that in 98.6% of patients the maximum diameter of the aneurysm sac decreased (63.9%) or remained stable (34.7%).
"The data are outstanding and presented no clinical issues that warranted an FDA Panel for approval. We can now initiate a focused launch of the product in the US The first phase will be obtaining hospital approvals and beginning the process of physician training as it relates to patient selection and technique for the Powerlink system," said Mr McCormick. "We will launch the Powerlink system with a handful of well trained, qualified sales representatives in well defined territories. We will make the necessary investments in training and time to ensure quality outcomes comparable to those achieved by our investigators in our pivotal trial."
"A number of large medical device companies have stumbled and failed with their early ELG efforts," continued Mr McCormick. "This is a significant opportunity and we will learn from their mistakes. Simultaneously we will optimize the size of our support infrastructure in preparation for an expansion of the sales and marketing organization. Ultimately, our marketing strategy is to build a 35-45 direct person sales organization in the US."
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