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.
