Drug Eluting Balloons Show Promise as a Potential Alternative to Drug Eluting Stents Used in the Treatment of Coronary Artery Disease.

Initial Clinical Studies of Novel Coated Balloon Presented at TCT 

WASHINGTON -- Drug eluting balloons could offer a viable alternative to drug eluting stents (DES) in the treatment of coronary artery disease. Research results from two studies presented today at the Late Breaking Trials sessions during the Cardiovascular Research Foundation's (CRF) Nineteenth Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in Washington, D.C. support conducting further studies of the use of this potential therapeutic alternative. One of the studies marked the first direct comparison between DES and drug eluting balloons.

Used to open atherosclerotic arteries, DES have come under intense scrutiny over the last several years, prompting the U.S. Food and Drug Administration (FDA) to form a special advisory board to investigate claims of complications. Recent studies have suggested that the polymer coating of these stents might be implicated in the reported complications.

The "SeQuent([TM]) Please"1 drug eluting balloon catheter from B. Braun Melsungen AG in Germany delivers drugs directly to the lesion during angioplasty. A pilot study published last year in the New England Journal of Medicine first shed light on this potential treatment option.2

In the PEPCAD II study, Dr. Martin Unverdorben (Rotenburg, Germany) directly compared "SeQuent([TM]) Please" to another manufacturer's DES in 131 patients over six months. The team evaluated restenosis - the re-closing or narrowing of the artery after a cardiac procedure - and the rate of major adverse cardiac events (MACE) such as heart attack, bypass, repeat stenosis, or death. Proving patients treated with the drug eluting balloons experienced only 3.7 percent restenosis and 4.8 percent MACE, as compared to patients with DES, wherein restenosis was 20.8 percent with 22.0 percent MACE rate.

Further supporting these results, a separate study by Unverdorben evaluated the use of drug eluting balloons for the treatment of small vessel disease in 120 patients. PEPCAD I is the first study to investigate the use of drug eluting balloons in "native" lesions - those who have not already been treated by DES or bare metal stents. After six months, native lesions treated solely with "SeQuent[TM] Please" showed only a 5.5 percent binary restenosis rate and 6.1 percent MACE. These results compare quite favorably with previously published results using drug-eluting stents for the treatment of small vessel disease with 31.2 percent restenosis and 18.9 percent MACE.

"Cardiovascular disease is the leading cause of death in the western world, and advances in its treatment are imperative," said Dr. Michael Boxberger, Director of Clinical Science, B. Braun Melsungen AG. "The results of these studies represent a positive development in the future of treatment of coronary artery disease, particularly for patients whose only treatment option previously was coronary stenting. Although further investigation is needed, drug eluting balloons alone or in combination with bare metal stents could potentially reduce the use of or replace drug eluting stents for a wide range of indications."

The development of "SeQuent([TM]) Please" for the treatment of coronary artery disease is made possible through B. Braun Melsungen AG agreement with Charite Hospital in Berlin, Germany. The product features a unique matrix coating which is fully bioabsorbable and polymer-free, enhancing the drug transfer into vascular tissue.

About B. Braun

B. Braun is the recipient of the 2007 Frost & Sullivan Medical Technology Global Excellence Award for its excellence in helping healthcare providers improve the lives of their patients. B. Braun Smart Pumps have achieved "Category Leader" in the KLAS Top 20 Mid-Year Report Card for Smart Pump Technology, 2007.

Since its founding in 1839, B. Braun has built an unparalleled store of knowledge and expertise in delivering innovative healthcare products, medical devices and programs that enhance working processes in hospitals, alternate care settings and medical practices - increasing safety for patients, doctors and nurses. Its 34,000 employees worldwide are proud of their commitment to translating customer needs into products with unmatched quality, superior technology, cost-effectiveness and environmental responsibility.

Through its "Sharing Expertise[R]" initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services. For more information about B. Braun or its safety healthcare products, call 800-854-6851, email us at [e-mail] or visit B. Braun at www.bbraunusa.com.

1 SeQuent Please is not approved or available for sale in the United States

2 Scheller et, al. "Treatment of Coronary In-Stent Restenosis with a Paclitaxel-Coated Balloon Catheter." New England Journal of Medicine. November 16, 2006. Scheller presented the latest results of his ISR I and ISR II studies at TCT.