Biospace.com, April 19, 2004
EndoBionics, Inc. Receives FDA 510(k) Clearance For MicroSyringe
SAN LEANDRO, Calif., April. 19 /PRNewswire/ — EndoBionics Inc. announced today that the Food and Drug Administration has allowed the marketing of the company's MicroSyringe catheter for the infusion of therapeutic and diagnostic agents that are indicated for delivery into the vessel wall or perivascular area.
The MicroSyringe is a wire-guided needle injection catheter that is threaded through the blood vessels to the deep tissues of the body, including the heart and other major organs. For the first time, physicians are able to inject drugs directly via the vasculature into the deep tissues of the body without major surgery. Instead, the physician positions the device in the vessel of interest, deploys its microneedle through the blood vessel wall, and delivers the drug directly to the targeted tissue.
Preclinical studies of therapeutics delivered by the MicroSyringe have shown remarkable diffusion, retention and efficacy. These studies included anti-restenosis drugs, antibiotics, immunosuppressants, cancer agents, genes and the injection of autologous stem cells that could prevent, or even reverse the effects of heart disease. Heart disease is the leading cause of death in the United States.
"The FDA clearance allows us to accelerate collaboration with scientists and companies who are seeking highly efficient, site-specific delivery of drugs, genes, proteins and cell therapies," said Lynn Barr, President of EndoBionics. "We have shown the safety and efficacy of the delivery device for the cleared indication, and now look forward to filing multiple applications for other specific indications. EndoBionics is a privately owned medical-device company based in San Leandro, Calif. The company is focused on developing, manufacturing, and marketing innovative catheter-based biotechnology solutions for heart disease, neurological disease and cancer. EndoBionics' web address is http://www.endobionics.com/ .
For more information, call 510-614-4550.