AtriCure Announces the First Patient Enrolled in the FROST Cryoanalgesia Study
FROST will evaluate cryoablation of peripheral nerves for the temporary management of post-operative
pain
AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in surgical treatments for atrial fibrillation (Afib) and left atrial
appendage management, today announced the first patient has been enrolled in the FROST study at William Beaumont Hospital,
Dearborn, MI. This company-sponsored trial will evaluate intraoperative cryoanalgesia therapy using cryoablation in conjunction
with standard of care (SOC) pain management compared to SOC alone.
The design of the trial is a prospective, 3:1 randomized trial including a total of up to 100 patients. The randomization will
include up to 75 patients in the treatment arm (intraoperative cryoablation plus SOC), and up to 25 patients in the control arm
(SOC alone). The study will include patients undergoing unilateral thoracotomy cardiac procedures and will evaluate pain scores and
lung function recovery during hospital stay.
“FROST is the first prospective study of the cryoICE system evaluating its ability to manage post-operative pain, enabling
faster and more complete patient recovery,” said Michael Carrel, President and Chief Executive Officer of AtriCure “Since
we launched our temporary pain management indication under 510(k) clearance in early 2015, adoption of this therapy has been solid,
as surgeons see the positive effects on their patients. This study is designed to provide further clinical and scientific
evidence.”
The primary objective of the study is to demonstrate that intraoperative intercostal cryoanalgesia in conjunction with SOC
provides improved analgesic efficacy and faster, more complete recovery in patients undergoing unilateral thoracotomy cardiac
procedures as compared to current SOC. Additional endpoints, such as ICU length of stay, total hospital length of stay, opioid
consumption, and long-term neurologic recovery will be gathered.
“In my experience, cryoanalgesia appears to result in improved pain management,” said Dr Steven F. Bolling, Professor of Cardiac
Surgery at University of Michigan Medical Center. “Perhaps more importantly, patients seem to extubate sooner and seem to be ready
for an earlier discharge. FROST will seek to confirm this effect at multiple cardiac surgery institutions.”
“I have continued to see the benefits of cryoanalgesia therapies in conjunction with minimally invasive mitral valve surgery,”
stated Dr. Francis Shannon, cardiothoracic surgeon, Beaumont Health System. “The benefit for patients is quite
significant, and I look forward to developing further evidence through participation in the FROST study.”
Participating centers in the study are the William Beaumont Hospital, the University of Michigan Medical Center, as well as
Cleveland Clinic Foundation. The coordinating investigators for the FROST study are Dr. Wei Lau and Dr. Francis Shannon at William
Beaumont Hospital. Dr. Andrea Trescot, past president of the American Society of Interventional Pain Physicians is serving as
Scientific Advisor for this trial.
“Today’s pain management options offer relief while patients are hospitalized, but do little to address pain post-discharge,”
said Dr. Wei Lau, Professor of Anesthesiology at Oakland University William Beaumont School of Medicine. “We have seen
cryoanalgesia control pain and improve recovery post-operatively.”
About AtriCure
AtriCure, Inc. is a medical device company providing innovative atrial fibrillation (Afib) solutions designed to produce
superior outcomes that reduce the economic and social burden of atrial fibrillation. AtriCure’s Synergy™ Ablation System is the
first and only surgical device approved for the treatment of persistent and longstanding persistent forms of Afib in patients
undergoing certain open concomitant procedures. AtriCure’s AtriClip® left atrial appendage management (LAAM) exclusion device
is the most widely sold device worldwide that is indicated for the occlusion of the left atrial appendage. The company believes
cardiothoracic surgeons are adopting its ablation and LAAM devices for the treatment of Afib and reduction of Afib related
complications such as stroke. AtriCure recently acquired nContact, a leader in minimally invasive technology for epicardial
ablation. nContact’s mission is to transform the underserved arrhythmia population through a multidisciplinary
epicardial-endocardial ablation approach. Afib affects more than 33 million people worldwide. For more information visit
AtriCure.com or follow us on Twitter @AtriCure.
Forward-Looking Statements
This press release contains “forward-looking statements”--that is, statements related to future events that by their nature
address matters that are uncertain. For details on the uncertainties that may cause our actual results to be materially different
than those expressed in our forward-looking statements, visit http://www.atricure.com/fls as well as our Annual Reports on Form 10-K and Quarterly Reports on Form 10-Q which
contain risk factors. We do not undertake to update our forward-looking statements. This document also includes forward-looking
projected financial information that is based on current estimates and forecasts. Actual results could differ materially.
AtriCure, Inc.
Media Relations
Valerie Storch-Willhaus, 612-605-3311
Director, Corporate Marketing and Communications
vstorch-willhaus@atricure.com
or
Investor Relations
Andy Wade, 513-755-4564
Senior Vice President and Chief Financial Officer
awade@AtriCure.com
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