On-X Life Technologies Reports CE Mark Approval to Sell Its Mechanical Aortic Heart Valve with an Expanded Labeling Claim: a Reduction in the Required Use of Blood Thinners
This approval allows European clinicians to maintain patients on a
lower dose of anticoagulant, which has been shown in a multicenter
clinical trial (PROACT: Prospective On-X Anticoagulation Clinical Trial)
to decrease bleeding by more than 50%. Clyde Baker, CEO
AUSTIN, Texas--(BUSINESS WIRE)--
announced today that its previously CE
(Conformité Européenne)-marked has
received European regulatory approval for an ,
which now permits the company to market its breakthrough mechanical
heart valve in Europe with a .
An INR blood test
measures the time it takes for patients blood to clot.
here to view corporate video
The expanded labeling claim was supported by interim data from a
recently completed arm of an FDA IDE clinical trialrospective andomized
n-X nticoagulation linical rial
(PROACT)presented by principal investigator ,
Cardiothoracic Surgery, Emory University, Atlanta, at the annual
scientific meeting of the American Association for Thoracic Surgery
(AATS). These data demonstrated the safety of maintaining On-X®
Prosthetic Heart Valve patients on a reduced anticoagulation therapy
regimen while decreasing bleeding complications by more than 50 percent.
On-X is the first prosthetic heart valve designed to combine the
durability of a mechanical valve with the reduced complication rates of
tissue valves, said , On-X LTIs founder.
This is a significant medical advance for aortic heart valve patients
in Europe, said Clyde
Baker, President and CEO, On-X Life Technologies. In the past, the
primary concern related to mechanical heart valves had been the
requirement for complementary anticoagulation therapy despite its
well-documented risk of bleeding. Now, On-X Plus 1.5 Aortic Valve
recipients in Europe will be able to take a lower level of anticoagulant
that will reduce the potential incidence of bleeding complications
caused by taking the higher dosages normally prescribed after receiving
a mechanical heart valve. We will commence marketing efforts with our
new labeling claim immediately.
It changes our perspective on how patients can be managed if they have
an On-X mechanical valve with respect to their wafarin or Coumadin
dose, said Marc Gerdisch, M.D., cardiac surgeon, PROACT investigator.
We have always known that most people age 65 or younger should be
treated with a mechanical valve. Now we recognize that the On-X valve
provides the additional advantage of being able to maintain the blood
thinner at a lower dose, and in fact improve safety, because the
incidence of bleeding events is less.
I think this is a potential game-changing, paradigm-shifting
opportunity in clinical cardiac medicine and in valve disease in
general, said Mohan Sathyamoorthy, M.D., cardiologist. I think the
really exciting aspect is the potential to reduce anticoagulation
On-X is proud of its investment into this research and clinical effort.
The On-X Plus 1.5 valve is designed to be the next step in the evolution
of valve technology, added Clyde Baker, CEO. The approval of an
expanded labeling claim in Europe sets the On-X aortic valve apart from
all other mechanical valves and also offers a new option to patients in
their 50s and 60s who are considering a tissue valve. These patients
are expected to live an additional 20 years. Tissue valve failure is
documented to occur between eight to 16 years post-implant. Replacement
valve surgery will be necessary for these patients when they are in
their 70s and 80s. Now that it has been shown to be safe to use the
On-X mechanical valve with low levels of warfarin, these patients and
their surgeons have a new valve option available. One that will likely
last the rest of their life.
The On-X heart valve is the result of a breakthrough in medical grade
carbon technology: On-X pure pyrolytic carbon. In addition to providing
a more thromboresistant surface, the comparatively high strength of pure
On-X Carbon has enabled On-X LTI to make significant valve design
changes that have resulted in a prosthesis that acts more like a natural
valve in its treatment of blood. Clinical studies have documented that
the On-X valve does not produce the turbulence and blood damage commonly
produced by other mechanical heart valve prostheses and, therefore,
significantly reduces the potential for life-threatening blood clots,
which is the basis of the expanded labeling claim recently granted to
On-X LTI in the European Union.
On-X Life Technologies (On-X LTI) develops mechanical heart valve
replacements that are designed to dramatically improve the quality of
life of patients. Headquartered in Austin, Texas, On-X LTI is a
privately held company. More information is located at www.onxlti.com.
On-X is a registered trademark of On-X Life Technologies Inc. All other
trademarks mentioned herein belong to their respective companies.
The approval of a lower INR recommendation through the EU regulatory
process applies only within that jurisdiction and others that accept EU
review. This therapy is not approved in the US or other countries that
have reviews independent of the EU. In these countries On-X Life
Technologies, Inc., continues to recommend standard anticoagulation
therapy as presently prescribed by various professional societies for
the On-X valve. On-X aortic and mitral valves are FDA
CAUTION: Federal law restricts this device to sale by or on the order of
a physician. Refer to the Instructions for Use that accompany each valve
for indications, contraindications, warnings, precautions and possible
complications. CAUTION: Investigational use of this device in the
Prospective Randomized On-X Valve Anticoagulation Trial (PROACT) is
limited by federal law to investigational sites. For further
information, visit www.onxlti.com.
ACC/ AHA 2006 Guidelines for the Management of Patients
With Valvular Heart Disease: A Report of the American College of
Cardiology/American Heart Association Task Force on Practice Guidelines
(Writing Committee to Revise the1998 Guidelines for the Management of
Patients With Valvular Heart Disease): Developed in Collaboration With
the Society of Cardiovascular Anesthesiologists Endorsed by the Society
for Cardiovascular Angiography and Interventions and the Society of
Thoracic Surgeons Circulation 2006;114;84-231. DOI:
Ronald Trahan Associates Inc.Ronald Trahan, APR, +1-508-359-4005,
Source: On-X Life Technologies