NATICK, Mass., Jan. 23 /PRNewswire-FirstCall/ -- Boston Scientific Corporation today announced positive results from its Renaissance trial, which was designed to study the safety and effectiveness of the Express(R) SD Renal stent in the treatment of renal artery disease. Results were presented by Krishna Rocha-Singh, M.D., F.A.C.C., of Prairie Cardiovascular Heart Institute in Springfield, IL and the study’s principal investigator, at the International Symposium on Endovascular Therapy (ISET) in Miami Beach.
Renaissance is a prospective, single-arm, multi-center study involving 100 patients in 14 sites in the United States. The primary endpoint of the study is restenosis, or the re-narrowing of a previously stented vessel, at nine months. The restenosis rate was compared to a benchmark of 40 percent determined by a literature review of similar endpoints in patients undergoing balloon angioplasty of the renal artery. Dr. Rocha-Singh reported a restenosis rate of 21.3 percent, which was significantly lower than the 40 percent benchmark.
“The Renaissance study provides critical insight into the occurrence and treatment of renal artery disease,” said Dr. Rocha-Singh. “Physicians have seen poor results treating this disease with a balloon alone, so it’s gratifying to see an improved outcome when incorporating the Express SD Renal stent.”
“These results will be used by Boston Scientific to seek approval from the Food and Drug Administration to make the Express SD Renal stent available for use in the renal arteries,” said John Pedersen, President of Boston Scientific’s Peripheral Interventions business. “It will be the first low- profile stent specifically approved for use in the renal arteries, which should allow physicians to deliver the stent in more complex cases.”
Dr. Rocha-Singh also reported excellent safety results, with a Major Adverse Event (MAE) rate of 10.5 percent, including no in-hospital events and no reported stent thromboses. In addition, he reported a low target lesion revascularization (TLR) -- or repeat procedures due to re-narrowing of the vessel -- rate of 8.4 percent. The trial also demonstrated excellent follow- up success with 93 of the 100 patients having ultrasound performed at nine months post implantation of the stent.
“A 93 percent follow-up rate demonstrates excellent execution and integrity of a clinical trial,” said Dr. Rocha-Singh. “We will continue to carefully monitor the progress of these patients with follow-up at two years and yearly out to five years. This will help us gain a better understanding of the long-term effects of the Express Renal SD stent in treating renal artery disease.”
Renal artery disease is the narrowing of the blood supply to the kidneys due to atherosclerosis, or the formation of plaque within the arteries. When the kidneys have a normal blood supply, they filter toxins from the blood and help to keep blood pressure in the normal range. Renal artery disease may lead to high blood pressure, poor kidney function or even kidney failure and dialysis.
Renal artery disease can be treated surgically or less invasively via angioplasty, or the placement of a balloon at the site of the lesion. The balloon is inserted through a small incision in the groin and fed through the artery on a catheter until it is positioned at the site of the blockage. The balloon is inflated, compressing the plaque against the walls of the artery, and then removed. Renarrowing of the arteries is common with this treatment method, however, leading to the study of stenting as a treatment option. A stent is an expandable metal mesh tube that remains in the artery after the removal of the balloon that supports the vessel wall to maintain blood flow through the newly opened vessel.
Boston Scientific is a worldwide developer, manufacturer and marketer of medical devices whose products are used in a broad range of interventional medical specialties. For more information, please visit: http://www.bostonscientific.com.
This press release contains forward-looking statements. The Company wishes to caution the reader of this press release that actual results may differ from those discussed in the forward-looking statements and may be adversely affected by, among other things, risks associated with, clinical trials, the regulatory approval process, reimbursement policies, commercialization of new technologies, intellectual property, litigation and other factors described in the Company’s filings with the Securities and Exchange Commission.
Contact Milan Kofol Charles Rudnick 508-650-8569 508-650-8660 Investor Relations Media Relations Boston Scientific Corporation Boston Scientific Corporation
Boston Scientific Corporation
CONTACT: Milan Kofol, Investor Relations, +1-508-650-8569, or CharlesRudnick, Media Relations, +1-508-650-8660, both of Boston ScientificCorporation
Web site: http://www.bostonscientific.com//