- 100% Free from Detectable AFIB -
Toronto Stock Exchange Symbol: CYT
MONTREAL, March 8 /CNW/ - CryoCath (TSX: CYT), the global leader in
cryotherapy products to treat cardiovascular disease, today announced six
month follow up data from 18 patients treated during the feasibility stage of
its STOP AF IDE trial. The trial, which is now in the pivotal stage, is
assessing the Company's proprietary Arctic Front(R) catheter to treat Atrial
Fibrillation (AFIB), the most prevalent cardiac arrhythmia affecting more than
4.3 million people worldwide.
Of the total 33 patients treated during the feasibility stage, the second
cohort of 18 patients, which have been treated with 23 mm or 28 mm catheters
as in the pivotal trial, has now reached the 6-month mark. All patients from
the second cohort were free of detectable AFIB at six months. Three of the
patients required a second procedure which is permissible under the protocol
set for the trial. Of these three patients, one is still receiving
anti-arrhymthmic drug (AAD) treatment. All of the remaining 17 patients are
off AAD's. No serious adverse events were reported other than two phrenic
nerve palsies. These two patients were asymptomatic at the time of hospital
release post procedure. In comparison to the original fifteen patients in the
first cohort of which 73% were AFIB free at the 6-month mark, these new
results show a noteworthy improvement.
"The data that continues to emerge from this trial is very encouraging.
These results show an improvement over the first cohort of 15 patients and
underscore the consistency of Arctic Front as a treatment alternative for
AFIB," said Jean-Pierre Desmarais, Chief Scientific Officer, CryoCath. "In
comparison to the 40 per cent success rate reported in medical literature
using current AAD therapies, these results are outstanding. They underpin our
conviction that Arctic Front has strong potential to become the new gold
standard of therapy to treat AFIB and consolidate the momentum we have gained
in the pivotal study."
As well, CryoCath announced it has received CE Mark approval for its
Generation V Universal Console. In addition to several technical improvements,
this next generation console is the first that can operate both CryoCath's
focal Freezor(R) line of catheters as well as Arctic Front.
"Seeing this data emerge is very exciting. Clinical outcomes like these
continue to build our confidence for the STOP AF trial and will further drive
adoption in Europe and other regions," said Jan Keltjens, President and CEO of
CryoCath. "And, with the continual improvements to our products, like the new
Universal Console, we demonstrate our dedication to becoming the dominant
provider of AFIB solutions."
About Arctic Front
Arctic Front is a minimally invasive cryo-balloon catheter designed
specifically to treat Atrial Fibrillation. This bi-directional, double balloon
catheter enables physicians to rapidly isolate all four pulmonary veins for
the treatment of AF. Approved in Europe, it has treated more than 500 patients
in more than 24 centers.
CryoCath - www.cryocath.com - is a medical technology company that leads
the world in cryotherapy products to treat cardiovascular disease. With a
priority focus on providing physicians with a complete solution of catheter
and surgical products to treat cardiac arrhythmias, CryoCath has multiple
products approved in the U.S., across Europe and several ROW countries. The
Company is developing additional products to expand its pipeline of products
to treat cardiac arrhythmias.
This press release includes "forward-looking statements" that are subject
to risks and uncertainties, including with respect to the timing of regulatory
trials and their outcome. For information identifying legislative or
regulatory, economic, climatic, currency, technological, competitive and other
important factors that could cause actual results to differ materially from
those anticipated in the forward looking statements, see CryoCath's annual
report available at www.sedar.com under the heading Risks and Uncertainties in
the Management's Discussion and Analysis section.
For further information:
For further information: visit our website at www.cryocath.com, or
contact: Michael Moore, Investor Relations, Phone: (416) 815-0700 ext. 241,
Fax: (416) 815-0080, E-mail: email@example.com