AtriCure’s cryoablation system receives US FDA clearance
8 April 2009
AtriCure, Inc. (Nasdaq: ATRC), has announced that its new disposable
cryoablation system, Cryo1, received 510(k) clearance from the US FDA
for the cryosurgical treatment of cardiac arrhythmias.
Additionally, the first patient was successfully treated using the
Cryo1 system by Dr Niv Ad, the Chief of Cardiac Surgery at Inova Fairfax
Hospital Department of Cardiovascular and Thoracic Surgery in Falls
Church, Virginia. Dr Ad successfully used the AtriCure Frigitronics
CCS-200 console and the Cryo1 linear disposable ablation probe to
perform a minimally invasive, sole therapy cardiac ablation procedure.
“The design and capabilities of the Cryo1 probe build on the high
performance of the AtriCure Frigitronics platform. During this initial
case we took advantage of the system’s unique capability to use reusable
and disposable cryothermy ablation probes during the same procedure,”
said Dr Ad. “The active defrost function and the probe rigidity made the
Cryo1 probe easy to use. This is a promising new technology and we look
forward to further use and evaluation of the system.”
“The commercial release of our Cryo1 system further positions
AtriCure as the leader in the surgical markets for cardiac ablation
products. AtriCure is now the only cardiac surgical ablation company
marketing a series of cryothermy and bipolar radiofrequency ablation
systems combined with an innovative portfolio of enabling tools and
mapping products,” said David J. Drachman, President and Chief Executive
Officer.
“We are excited to offer this new innovative technology solution
which we believe will lead to market share gains and demonstrates our
continued commitment to developing innovative technologies.”
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