ATLANTA, Sept. 21 /PRNewswire-FirstCall/ -- CryoLife, Inc. (NYSE: CRY) -- Elite cardiovascular surgeons from around the world will travel to suburban Atlanta this week for the two-day Ross Summit to review and discuss current peer-reviewed data relating to the survival advantage of the Ross Procedure and to practice the technical nuances required to perform this heart surgery successfully.
The Ross Procedure is a type of specialized aortic valve surgery in which the patient's diseased aortic valve is replaced with his or her own pulmonary valve. The pulmonary valve can then be replaced with a cryopreserved human pulmonary valve.
Nine peer-reviewed articles regarding the Ross Procedure representing individual series from eight different countries, comprising a total of 2,234 patients have appeared in major medical journals over the past four years and report that:
Led by Professor Sir Magdi Yacoub, FRS, FRCS, of Imperial College's Heart Science Center in London in tandem with William F. Northrup III, MD, vice president of physician relations and education at CryoLife, the Ross Summit will have a faculty of more than 30 world-renowned cardiovascular surgeons and cardiologists, who will present clinical data on heart reconstruction surgery at their respective clinics. The summit includes two sessions of hands-on instruction in the various techniques of cardiac reconstruction.
The Ross Procedure is performed on up to 1,500 individuals globally each year -- a number that is expected to increase as survival data become more widely known.
"In children, young adults and in active older adults, the Ross Procedure offers several advantages over other traditional aortic valve replacement options," said Dr. Northrup. "The most important advantage is growing evidence of improved long-term survival over other valve replacement options. The procedure is also attractive because patients do not have to take long-term, blood-thinning medications after surgery as they would with mechanical valves. This is particularly appealing to women of child-bearing age, athletes and active adults."
These clear advantages along with the growing catalog of survivability data spotlighted at the summit are bringing new attention to the procedure from surgeons and potential patients.
"The Ross Procedure requires very specific surgical expertise to achieve predictable, long-lasting results, and The Ross Summit was created to foster data exchange to provide a well-rounded point of view in addition to offering critical procedural training," noted Steven G. Anderson, chairman, president and CEO of CryoLife.
A decellularized human pulmonary heart valve, CryoValve(R) SG, processed using CryoLife's SynerGraft(R) technology, was cleared by the FDA in February 2008 for use in cardiac reconstruction procedures, which includes the Ross Procedure.
About CryoLife, Inc.
Founded in 1984, CryoLife, Inc. is a leader in the processing and distribution of implantable living human tissues for use in cardiac and vascular surgeries throughout the U.S. and Canada. The Company's CryoValve(R) SG pulmonary human heart valve, processed using CryoLife's proprietary SynerGraft(R) technology, has FDA 510(k) clearance for the replacement of diseased, damaged, malformed or malfunctioning native or prosthetic pulmonary valves. The Company's BioGlue(R) Surgical Adhesive is FDA approved as an adjunct to sutures and staples for use in adult patients in open surgical repair of large vessels. BioGlue is also CE marked in the European Community and approved in Canada and Australia for use in soft tissue repair. The Company's BioFoam(R) Surgical Matrix is CE marked in the European Community for use as an adjunct in the sealing of abdominal parenchymal tissues (liver and spleen) when cessation of bleeding by ligature or other conventional methods is ineffective or impractical. BIOGLUE Aesthetic(TM) Medical Adhesive is CE marked in the European Community for periosteal fixation following endoscopic browplasty (brow lift) in reconstructive plastic surgery and is distributed by a third party for this indication. CryoLife distributes HemoStase(TM), a hemostatic agent, in much of the U.S. for use in cardiac and vascular surgery and in the European Community and Canada for cardiac, vascular, and general surgery, subject to certain exclusions.
Statements made in this press release that look forward in time or that express management's beliefs, expectations or hopes are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include those regarding the expected increases in the number of Ross Procedures, the expected impact of Ross Procedure advantages and evidence of long-term survival, CryoLife's belief that evidence of long-term survival is expected to grow, and growing evidence to support improved long-term survival rates for patients undergoing Ross Procedures as compared to other valve replacement options. These future events may not occur as and when expected, if at all, and are subject to various risks and uncertainties, including that additional studies may not provide the support for the advantages and long-term survival rates expected, and competitive advances, regulatory challenges, increased costs, unexpected side effects or other factors outside CryoLife's control could result in physicians' or patients' decisions not to choose the Ross Procedure. Additional risks and uncertainties impacting CryoLife's business are detailed in CryoLife's Securities and Exchange Commission filings, including CryoLife's Form 10-K filing for the year ended December 31, 2008, our Form 10-Q for the quarter ended March 31, 2009, our Form 10-Q for the quarter ended June 30, 2009, and the Company's other SEC filings. The Company does not undertake to update its forward-looking statements.
For additional information about the company, visit CryoLife's Web site: www.cryolife.com.
Reference Articles Listed Above:
Klieverik LMA, Takkenberg JJM Bekkers JA, et al. The Ross Operation: a Trojan horse? Eur Heart J 2007;28:1993-2000.
Yacoub MH, Klieverik LMA, Melina G, er al. An evaluation of the Ross Operation in adults. J Heart Valve Dis 2006;15:531-539.
Seivers, HH, Hanke T, Stierle U, et al. A critical reappraisal of the Ross Operation. Renaissance of the subcoronary implantation technique? Circulation 2006;114[suppl I]:I:504-I-511.
Elkins RC, Thompson DM, Lane MM, et al. Ross Operation: 16-year experience. J Thorac Cardiovasc Surg 2008;136:623-630.
David TE. Editorial. Ross procedure at the crossroads. Circulation 2009;119:207-209.
Alsoufi, B., Al-Halees Z, Manlhiot C, et al. Mechanical valves versus the Ross procedure for aortic valve replacement in children: Propensity-adjusted comparison of long-term outcomes. J Thorac Cardiovasc Surg 2009;137:362-370.
Favaloro RR, et al. Aortic Valve replacement: Ten-Year Follow up of the Ross Procedure. J Heart Valve Dis 2008;17;501-507.
da Costa FDA, et al. Thirteen Years' Experience with the Ross Operation. J Heart Valve Dis 2009;18:84-94.
Brown JW, et al. Midterm Results of Ross Aortic Valve Replacement: A Single-Institution Experience. Ann Thorac Surg 2009;88:601-8.
Media Contacts: D. Ashley Lee Executive Vice President, Chief Financial Officer and Chief Operating Officer Phone: 770-419-3355 Dana Hartline Vice President Edelman Phone: 404-262-3000
|SOURCE CryoLife, Inc.|
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