Based on a two-part bioprosthetic tissue valve, the patented system promises to mitigate the compromises between traditional mechanical and tissue heart valves while providing maximal patient benefits.
Globally, 95 percent of all valve replacements are for aortic or mitral valves and require major surgery, which in some cases is associated with inflammation and ultimately prolong recuperation time. Of the two options – tissue or mechanical replacement valves – available to patients, tissue valves remain the preferred option. These originate from animal tissue and closely resemble the patient's original valve, and do not require long-term anticoagulation therapy with its inherent lifestyle impact. However, these bioprosthetic valves themselves may require a replacement within the patient’s lifetime. To replace the worn-out valve, the patient undergoes the same invasive procedure as before (opening the chest and putting the patient on the cardiopulmonary bypass pump for the second time). This can lead to significant risk and trauma for the patient, and therefore these valves have been primarily used for the geriatric population. More durable, longer-lasting mechanical valves have traditionally been used for younger patients, but they carry an increased risk for blood clotting, which necessitates lifelong anticoagulation therapy with significant lifestyle adjustments. The ValveXchange approach offers the benefits of tissue valve technology to both younger and older patients.
“The ValveXchange Heart Valve System represents a safe and less invasive alternative to conventional therapies as a docking station for the prosthetic valve is installed during the initial surgery itself,” says Frost & Sullivan Research Analyst S.R. Priya. “Later when a replacement of the worn out valve leaflet set is needed, the replacement leaflet is conveniently substituted without the need for a full open-heart surgical valve replacement.”
The ValveXchange system comprises of a two-part valve and associated tools to facilitate initial implantation and subsequent leaflet-set exchange. The docking station, a permanent fixture, is surgically implanted and provides the basic support for the replaceable leaflet set. In other bioprosthetic valves particularly bovine pericardial valves, the pericardial tissue leaflets are permanently attached to the support frame. In the ValveXchange valve, three clips are employed for holding the leaflet set in place. When the leaflet set needs a replacement, typically many years after its initial implantation, it is released by a specific exchange tool in a foolproof manner. The exchange tool then is loaded with a new leaflet set which quickly snaps onto the docking station providing new-valve performance.
“ValveXchange is designing the system for a wide variety of surgical options for the leaflet exchange, including through a very small incision using a minimally invasive procedure, which does not necessitate cardiopulmonary bypass,” adds Priya. “As research and development continues in the future, varied patterns and materials of the leaflet set can be incorporated into the exchangeable component.”
The performance of the ValveXchange valve is designed to be on par with the Edwards bovine pericardial valve, the most commonly used tissue valve. Furthermore, the ValveXchange technology adapts to the aortic valve position, the first planned product, and later to the mitral and other valve positions. The docking station can be sewn into location without the valve leaflets in place: this confers maximum ease and flexibility for surgical implant. In the future, this can also allow the possibility of staples or mechanized suturing to be employed.
While the early part of ValveXchange’s research was supported by the National Institutes of Health (NIH), the company actively seeks both private and institutional investors for furthering its research and development and commercialization activities. It has already obtained four issued patents, and applications for additional patents have been filed for advanced valve technologies, accessory tools and access devices.
“Overall, the ValveXchange system provides the innate hemodynamic and non-thrombogenic benefits of tissue valves to patients of all ages, thus obviating the need for expensive and potentially problematic anti-coagulation therapies and major lifestyle modifications,” concludes Priya.
For this innovation that has the potential to revolutionize the valve replacement therapy paradigm by simplifying long-term management and future valve replacements, Frost & Sullivan is pleased to present ValveXchange, Inc. with the 2009 North American Award for Technology Innovation of the Year.
Each year, Frost & Sullivan presents this award to the company that has carried out new research, which has resulted in innovation(s) that have or are expected to bring significant contributions to the industry in terms of adoption, change, and competitive posture. This award recognizes the quality and depth of a company’s research and development program as well as the vision and risk-taking that enabled it to undertake such an endeavor.
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About ValveXchange, Inc.
ValveXchange, Inc. (valvexchange.com) is an emerging technology company located in Aurora, Colorado, developing a novel two-part tissue heart valve. The ValveXchange Vitality™ Heart Valve System is being designed to provide the patient with the lifestyle benefits of proven bovine pericardial tissue valve performance, with no long-term anticoagulation therapy required, and without future complicated open heart surgeries. The Vitality™ exchangeable leaflet set is designed for minimally invasive replacement when needed. Surgically implanted prosthetic heart valves represent about a $1 Billion annual market. ValveXchange believes its technology can become the product preferred by patients, physicians and third party payers in the majority of cases. Note: ValveXchange, Inc. products have not been approved by the U.S. FDA or any other regulatory agency.
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