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AtriCure Announces First Patient Enrollment in the DEEP IDE Trial Restart

April 23, 2019 Off By BusinessWire

The trial is intended to establish the safety and effectiveness of a
dual epicardial and endocardial ablation procedure for patients with
persistent or long-standing persistent atrial fibrillation

MASON, Ohio–(BUSINESS WIRE)–AtriCure, Inc. (Nasdaq: ATRC), a leading innovator in surgical treatment
for atrial fibrillation (Afib) and left atrial appendage management,
today announced the restart of the Dual Epicardial and Endocardial
Procedure (DEEP) clinical trial (NCT02393885). Following approval by the
FDA to restart the trial and enroll an additional 40 subjects, which was
granted in December 2018, the first patient was treated by a team led by
Professor Mark La Meir and Professor Carlo de Asmundis at Universitair
Ziekenhuis Brussels, Belgium.

The DEEP trial is a prospective, multicenter, single arm,
investigational device exempt (IDE) study to evaluate the safety and
efficacy of the DEEP procedure in treating persistent and long-standing
persistent atrial fibrillation. The DEEP procedure utilizes the
specialized skills of both the cardiac surgeon and electrophysiologist
(EP) for more severe cases of Afib, which have historically been the
most difficult patients to treat. Up to 220 patients will be enrolled at
up to 30 hospitals. Currently, 48 patients have been treated in the
trial.

The global principal investigators for this trial are Dr. Kenneth
Ellenbogen and Dr. Vigneshwar Kasirajan, from Virginia Commonwealth
University, and Dr. Ali Khoynezhad, from Memorial Care Health & Vascular
Institute at Long Beach, California.

“The DEEP trial brings electrophysiologists and cardiac surgeons
together as a team in an effort to establish a safe and effective care
pathway for patients presenting with persistent or long-standing
persistent Afib. We are excited about the restart of enrollment in this
important trial,” said Professor Mark La Meir, Professor of
Cardiothoracic surgery at UZ Brussels who along with Professor de
Asmundis treated the first patient upon restart.

“The DEEP trial reinforces AtriCure’s commitment to continue to expand
the presence in minimally invasive treatment of persistent and
long-standing persistent patients and to improve the lives of these
difficult to treat patients,” said Michael Carrel, President and Chief
Executive Officer of AtriCure. “We’ve worked very closely with the FDA
and with our investigators to do everything we can to ensure a safe,
effective and repeatable procedure.”

About AtriCure, Inc.

AtriCure, Inc. provides innovative technologies for the treatment of
Afib and related conditions. Afib affects more than 33 million people
worldwide. Electrophysiologists and cardiothoracic surgeons around the
globe use AtriCure technologies for the treatment of Afib and reduction
of Afib related complications. AtriCure’s Isolator^® Synergy™
Ablation System is the first and only medical device to receive FDA
approval for the treatment of persistent Afib. AtriCure’s AtriClip Left
Atrial Appendage (LAA) Exclusion System products are the most widely
sold LAA management devices worldwide. For more information, visit
AtriCure.com or follow us on Twitter @AtriCure.