AngioDynamics (NSDQ:ANGO) announced today that it received FDA 510(k) clearance and CE Mark approval for its SmartPort+ implantable port product.
SmartPort+ is an implantable, subcutaneous port for those who require long-term access to the central venous system for blood specimen withdrawal and administration of fluids, according to a news release.
Latham, N.Y.-based AngioDynamics’ device utilizes the company’s vortex technology with a round chamber and tangential outlet to hyper-cleanse the entire chamber, along with a BioFlo catheter with Endexo polymer technology that is blended into the polyurethane from which the catheter is made.
The company said it will immediately begin making SmartPort+ available across markets in the U.S. and Europe, following the clearances. The device launch will be supported by a launch of the SmartPort Plastic, a plastic alternative to SmartPort titanium.
Additionally, AngioDynamics is introducing a “Port Patient App” for mobile devices to allow patients to build a digital resource library for their ports. The company anticipates availability of the app on the Google Play and App Store markets.
“We are very pleased to have received FDA clearance and a CE Mark for SmartPort+, allowing us to bring this product to patients in the United States and Europe,” AngioDynamics senior VP & GM of the global vascular access business unit Chad Campbell said in the release. “SmartPort+, SmartPort Plastic, and the Port Patient App give providers and patients new options for effective management of medical needs. As the needs of patients and providers evolve, AngioDynamics continues to work closely with the medical community to develop products that meet patient needs and can help support treatment goals.”