Advertisement
News
Advertisement

Boston Biomedical Associates helps AtriCure's Synergy Ablation System win a Recommendation from FDA Expert Advisors

Fri, 10/28/2011 - 7:39am
NORTHBOROUGH, Mass.--(BUSINESS WIRE)--Boston Biomedical Associates today announced that AtriCure, Inc., a medical device company and a leader in cardiac surgical ablation systems and devices for the exclusion of the left atrial appendage, received a vote of approval support from the Circulatory System Panel of the U.S. Food and Drug Administration (FDA) for the AtriCure Synergy Ablation System. The panel voted in favor of FDA approval of the system for the treatment of persistent and longstanding persistent atrial fibrillation during open-heart concomitant surgical procedures. This marks the first time FDAs expert panel has voted to recommend a surgical ablation system to treat atrial fibrillation.

This announcement represents a significant achievement for Boston Biomedical Associates and AtriCure, Inc. Boston Biomedical Associates provided strategic consulting services to AtriCure, Inc. in support of its ABLATE clinical trial and PMA process including regulatory, clinical and statistical services. "We are pleased with the panels approval recommendation," said Lauren S. Baker, PhD, President, Boston Biomedical Associates. "The panels recommendation should lead to an increased awareness of treatment options for the most common sustained cardiac arrhythmia, atrial fibrillation."

"We would like to thank Boston Biomedical Associates for their support and assistance with the ABLATE trial and PMA process," said David J. Drachman, President and Chief Executive Officer of AtriCure, Inc. "The Boston Biomedical Associates team was instrumental in their support of AtriCure in executing our ABLATE trial, interacting with the FDA and preparing for the panel meeting. We are impressed with their extensive clinical and regulatory expertise as well as their professionalism and appreciate their support in working with us to achieve a positive panel vote."

About Boston Biomedical Associates

Boston Biomedical Associates has extensive expertise in guiding companies through the regulatory approval process, as well as post market activities (e.g. MDR, vigilance reporting). This expertise includes supporting domestic and international regulatory approvals, customizing Quality Systems to meet the needs of the regulations as well as the client. BBA also has a proven track record in the development, execution and successful completion of clinical trials leading to FDA approval/clearance for medical devices and biomedical technologies. BBAs focus is to deliver services to bring new technologies to market, on time, on budget, and with greater efficiency across a broad range of products and therapeutic areas. Boston Biomedical Associates has offices in Northborough, MA and San Francisco, CA. For more information visit: www.boston-biomedical.com.

Advertisement

Share this Story

X
You may login with either your assigned username or your e-mail address.
The password field is case sensitive.
Loading