ENDOLOGIX PROVIDES DETAILS OF Powerlink® SYSTEM PIVOTAL TRIAL AT ANNUAL MEETING OF THE EASTERN VASCULAR SOCIETY
The pivotal trial enrolled 193 test patients and 66 controls treated by conventional surgery. A total of 184 test patients were available for a minimum of one year follow up. The study demonstrated the following:
- The Powerlink System was successfully deployed in 97.9% of test patients.
- 31% of test patients were treated using regional or local anesthesia.
- Operative times, ICU time, blood loss, and hospital length of stay for the Powerlink System patients was significantly lower versus control patients.
- Significantly fewer Myocardial Infarctions, Renal Failures, or Respiratory Failures were reported during the 30 day perioperative period in the Powerlink System cohort compared to the control group.
- During the follow up period only one late conversion was performed which was to treat a refractory Type I endoleak, 18 secondary procedures were performed; with the majority of these being coil embolizations to treat Type II endoleaks.
- There were 5 migrations (>5mm) reported, with no clinical sequelae.
- Study results indicated a significant reduction in both sac diameter and volume at each follow up interval.
- There were no reported aneurysm ruptures, wire fractures, or Type III or IV endoleaks with the Powerlink System.
- Test patients were significantly older than control patients and were more likely to have had a prior abdominal surgery but did not differ significantly with respect to gender distribution or comorbidities.
“Despite the fact that the annual U.S. market for ELGs is in excess of $200 million, several manufacturers have withdrawn their ELG devices or halted clinical studies due to device malfunction and/or material failures,” said Paul McCormick, President and Chief Executive Officer of Endologix. “We believe that clinicians have been conservative in the application of these minimally invasive therapies, reserving the use of ELGs for high-risk surgical patients or those with no surgical option.
“Our study results from this, our most comprehensive trial to date, demonstrate a highly successful deployment rate as well as device durability,” added Mr. McCormick. “Based on the strength of our clinical data, we are even more convinced that the Powerlink System has multiple advantages and benefits compared with current alternatives, and very well may serve to expand the patient population for ELGs.”
The Powerlink System is a unibody self-expandable device, with a durable frame made of stainless steel alloy covered with an ePTFE graft. The one-piece bifurcated design featuring a fully supported stent cage was developed to overcome the many shortcomings associated with earlier-generation ELG devices. The Powerlink System is covered by 14 U.S. patents with 296 allowed claims. Upon receiving FDA marketing clearance the Company plans to initiate a focused U.S. product launch.
Endologix, Inc. develops and manufactures minimally invasive treatments for vascular diseases. AAA, a life threatening condition, is a weakening of the wall of the aorta, the largest artery in the body, resulting in a balloon-like enlargement. Once AAA develops, it continues to enlarge and, if left untreated, becomes increasingly susceptible to rupture. The overall patient mortality rate for ruptured AAAs is approximately 75%, making it the 13th leading cause of death in the United States. Most patients with an AAA do not exhibit any symptoms and the first sign oftentimes is a rupture of the aneurysm. When an AAA ruptures, patients will experience pain in the abdomen and back, fainting and loss of consciousness frequently leading to shock and death. Once diagnosed, AAA patients will be managed by a combination of medical therapy and non-invasive monitoring, or by undergoing a major surgical procedure to repair the aneurysm. Additional information about Endologix and its products can be found at www.endologix.com.
Except for historical information contained herein, this news release contains forward-looking statements, the accuracy of which are necessarily subject to risks and uncertainties, including risks related to clinical trials and the regulatory approval process, all of which are difficult or impossible to predict accurately and many of which are beyond the control of Endologix, all as more fully described in the risk factors and other matters set forth in the Company's Annual Report on Form 10-K for the year ended Dec. 31, 2003 and the Company’s other filings with the U.S. Securities Exchange Commission.