AngioDynamics Receives FDA Clearance and CE Mark for SmartPort+ Implantable Port
AngioDynamics, Inc. (NASDAQ: ANGO), a leading provider of innovative, minimally invasive medical devices for vascular access, peripheral vascular disease, and oncology, today announced that they have received 510(k) clearance from the U.S. Food & Drug Administration (FDA), as well as a CE Mark by the European Commission, for their SmartPort+ Implantable Port.
SmartPort+ is an implantable, subcutaneous port for patients who require long-term access to the central venous system for blood specimen withdrawal and administration of fluids.
“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,” said Chad Campbell, Senior Vice President and General Manager of AngioDynamics’ Global Vascular Access business unit. “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.”
SmartPort+ improves on standard implantable ports by combining two of AngioDynamics’ best-in-class technologies:
- Vortex Technology: the port’s round chamber and tangential outlet create a flushing action within the port to hyper cleanse the entire chamber, leading to a 73% reduction in the rate of occlusions and 69% fewer secondary interventions.
- A BioFlo catheter with Endexo Technology: Endexo Technology is a permanent and non-eluting polymer that is “blended” into the polyurethane from which the catheter is made and is present throughout the entire catheter. Endexo Technology remains present for the life of the catheter and provides a catheter material more resistant to thrombus accumulation.
AngioDynamics will immediately begin making SmartPort+ available in markets across the United States and Europe.
The release of SmartPort+ is supported by the launch of the SmartPort Plastic, a plastic alternative to the widely-utilized SmartPort Titanium. Leveraging Vortex Technology within the port and constructed of implantable-grade polysulfone (PSU), SmartPort Plastic offers health care providers and patients a new option for successful delivery of treatments.
To provide convenience and ease for users of SmartPort+ and other AngioDynamics implantable ports, AngioDynamics has developed a “Port Patient App” for mobile devices. The app, which will be available from Google Play and the App Store shortly, allows patients to build a digital resource library for their ports. The Port Patient App will feature useful information that is needed during medical visits, including the model of the patient’s port, maximum pressures and flow rates for their port, product support information, and important dates such as implantation and previous procedure dates.
About AngioDynamics, Inc.
AngioDynamics, Inc. is a leading provider of innovative, minimally invasive medical devices used by professional healthcare providers for vascular access, peripheral vascular disease, and oncology. AngioDynamics’ diverse product lines include market-leading ablation systems, vascular access products, angiographic products and accessories, drainage products, thrombolytic products and venous products. For more information, visit www.angiodynamics.com.
 Stevens, Barbara, et al. “A Randomized, Prospective Trial of Conventional Vascular Ports vs. the Vortex ‘Clear-Flow’ Reservoir Port in Adult Oncology Patients.” Journal of Vascular Access Devices, vol. 5, no. 2, 2000, pp. 37–40.
 The reduction in thrombus accumulation (based on platelet count) is supported by acute in-vitro testing. Pre-clinical in-vitro evaluations do not necessarily predict clinical performance with respect to thrombus formation. Data on file.
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