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Direct Flow Medical Presents Twelve
Month Clinical Results with their Percutaneous Aortic Valve
System at TCT
Santa Rosa, California, October 5, 2009 :: Direct
Flow Medical, Inc.,
www.directflowmedical.com released its 12 month data from
the initial clinical trial for a new device to treat valve
disease without invasive thoracic surgery. Direct Flow Medical
is a privately held, emerging medical device company developing
a next generation, catheter based, percutaneous delivered
prosthetic aortic valve. At the Transcatheter Cardiovascular
Therapeutics (TCT) meeting last month Professor Joachim Schofer
from Hamburg, Germany presented the prospective, non randomized
data from the European Feasibility and Safety Trial. A total of
31 patients were enrolled at 2 centers in this first in human
clinical trial.
The 1 year risk adjusted survival rate in this study was 72%
which is significantly better than the predicted survival of
this patient population if they were treated by conventional
surgery or medical management. The survival rate is comparable
to survival rates reported with the first generation
transcatheter aortic valve interventional (TAVI) devices now
commercially available in Europe.
The patients in the study also benefited from a significant
improvement in quality of life as measured by NYHA functional
class. Most patients had an improvement of at least two
functional classes. “The improvement in functional class appears
to be due to the low incidence of perivalvular leak, and the
unique ability of the Direct Flow device to seal to the native
annulus” stated Dr. Hendrik Treede a cardiothoracic surgeon and
study co-investigator in Hamburg.
Also at the TCT meeting, Professor Schofer reported 2 year data
on the first patient treated with the Direct Flow Medical 22F
Percutaneous Aortic Valve (PAV) System. Before treatment the 81
year old patient was suffering from critical aortic stenosis
with an effective orifice area of 0.56cm2 and was NYHA Class
III. Because of severe co-morbidities, the patient was not a
surgical candidate. At the two year follow-up the excellent
acute clinical result was maintained; the patient remains NYHA
Class I with a mean pressure gradient of 10mmHg, an effective
orifice area of 1.98cm2 and he maintains an active life style.
An additional 6 patients implanted with the Direct Flow Medical
device are surviving beyond 18 months post treatment despite
having an average age of 82 years and a logistic EuroScore of
greater than 27 at implant.
Professor Schofer stated, “We are pleased to report the positive
data, results and clinical outcomes demonstrated in our patients
at 1 year post implant and beyond, particularly in the areas of
stable post procedure gradients and improved NYHA functional
class. We anticipate that with the development of the new 18F
device from Direct Flow Medical we will be able to accelerate
patient enrollment and increase our clinical experience with
this unique, next generation device.”
About Direct Flow Medical, Inc.
Founded in 2004, the Company is headquartered in Santa Rosa,
California, has a second manufacturing facility in Lake Forest,
CA and employs approximately 75 people. The Company’s unique
implant design is not limited to aortic valve disease but is
readily applicable to mitral and other heart valve anatomical
sites as its placement and security in an annulus is not
dependent on calcium. Direct Flow Medical has raised 3 rounds of
funding to date with the following investors: EDF Ventures, New
Leaf Venture Partners, Spray Venture Partners, Foundation
Medical Partners, VantagePoint Venture Partners, ePlanet Venture
Partners and strategic investors.
Contact
Bernard E. Lyons, Ph.D., President/CEO, Direct Flow Medical,
Inc., (707) 576-0420
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