Medtronic Launches OptiSphere Embolization Spheres in the U.S.

Medtronic plc announced its U.S. launch of OptiSphere embolization spheres, a resorbable embolic platform designed for embolization of hypervascular tumors. OptiSphere offers patients an alternative treatment option, a resorbable embolic, with comparable results to a permanent embolic.¹
 
Hypervascular tumors can present as malignant or benign and can be found in various anatomical structures. Physicians may choose to treat these tumors with various therapies including, but not limited to, embolization, microwave ablation, radiofrequency ablation, or cryoablation.
 
“Medtronic continues to seek opportunities to expand the therapies we offer to patients and the physicians who treat them. With increased and better quality of care, the cancer patient population is living longer with the disease and it is important that we continue to introduce therapies that help positively impact and improve their quality of life,” said Jeff Cambra, general manager of the Pain Therapies Interventional business, which is part of the Restorative Therapies Group at Medtronic. “We consider this launch to be a win for both sides of the healthcare pathway, as OptiSphere addresses patient concerns of having permanent implanted spheres left behind while enabling physicians to offer an innovative treatment option in their facilities.”
 
OptiSphere is manufactured for Medtronic by Vascular Solutions, LLC, a subsidiary of Teleflex Incorporated. Medtronic continues to partner with the company to further innovate the technology. OptiSphere received U.S. Food and Drug Administration (FDA) 510(k) clearance in April 2014.
 
“Teleflex is very pleased to have Medtronic as a strategic distribution partner for our novel platform of embolic spheres,” said Jake Isenburg, Ph.D., director of Scientific Affairs for Teleflex. “The development of unique resorbable implants, particularly in the field of embolization, has become one of our core technical competencies at Vascular Solutions and Teleflex. By combining this technical expertise with Medtronic’s focus in interventional oncology, Teleflex is excited to collaborate on providing an alternative solution to healthcare professionals who are seeking a resorbable embolization product.”
 
OptiSphere short-term spheres have shown long-term results1 and offer an alternative solution for treating hypervascular tumors. The resorbable microspheres begin to degrade starting at four weeks post-procedure with significant degradation noted at nine weeks.¹
 
The spherical shape of OptiSphere provides smooth embolic delivery and even, predictable distribution. The product line offers procedural flexibility with two volume options and five size ranges which may be combined in a single procedure as needed to achieve the desired occlusion. Risks of embolization procedures may include, but are not limited to, non-target embolization and post-procedure syndrome; please refer to the product instructions for use for a full listing of the indications, contraindications, warnings, precautions and potential adverse effects.
 
Reference
¹Data on file based on animal testing. Pre-clinical studies are not indicative of human clinical outcomes.