Dynatek signs landmark contract with SFDA
SPRINGFIELD, MO — (MARKET WIRE) – April 15, 2008 – Dynatek dalta Scientific Instruments, the leader in the testing of cardiac and vascular devices, has successfully concluded negotiations with the State Food and Drug Administration, the People’s Republic of China to supply a Stent and Vascular Prosthesis Tester (SVP) to the SFDA Testing Center in Tianjin.
Negotiations with the SFDA were conducted through Dynatek’s representative, David Tseng of Princeton Medical Science LLC.
The SVP is a small vascular prosthesis tester designed to create accelerated cyclic pulsatile loading on stents and other products destined for the vasculature. The SVP operates by setting the baseline pressure, simulating the diastolic pressure, then pulsing the samples to simulate the systolic pressure using a bellows system for fluid delivery. This pulsing, when performed under recommended conditions, closely recreates the movement of the stent in vivo.
The SVP has recently been upgraded to incorporate two new major features: a Hyper Drive capable of testing speeds of up to 150 Hz, and a micro processor based controller that allows for enhanced levels of experimental control and data capture. The tester is due to be installed in May.
The sale of the SVP to the SFDA marks the culmination of a year of concerted effort and encouraging results for Dynatek in China. In September, Dynatek exhibited at MedTec China in Shanghai, and later the same month Dr. James Conti was appointed as Guest Professor of Harbin Engineering University. Harbin is in the process of establishing a Center of Excellence for Medical Device Testing, and Dr. Conti is honored to join their team: “Harbin is a very beautiful and technologically advanced engineering university and I look forward to assisting them in their introduction to the ISO.”
Efforts to develop a presence in this rapidly expanding market will continue this year with a repeat showing at MedTec China on September 9th through the 11th. Negotiations for the sale of a second tester to the SFDA are currently taking place.
About Dynatek dalta:
Dynatek Laboratories Inc, dba Dynatek dalta Scientific Intruments, is the leader in accelerated in vitro testing of cardiovascular devices, with over twenty years of experience. Having performed testing for many of the largest and smallest of companies, we are equipped to meet the testing needs of each individual client. As changes have occurred in stent designs and as more data have been collected concerning failure modes in vivo, Dynatek has modified its capabilities to address these changes, meeting and helping to further develop testing standards. Information on Dynatek’s SVP together with their other testing machines and testing services offered by Dynatek Laboratories can be found at www.dynateklabs.com.
Contact: Kendra Conti