A jury has ordered Nevro to pay Boston Scientific $20 million in a patent infringement case. The jury found that Nevo infringed on two of Boston Scientific's patents related to the manufacturing of spinal cord stimulation technology. Nevro said it plans to appeal. Nevro and Boston Scientific have been clashing over intellectual property since shortly after FDA approved Nevro's Senza spinal cord stimulation system in May 2015.
Despite getting shot down by a recent FDA advisory panel, Integra's management team still seems confident that the agency will ultimately approve SurgiMend for post-mastectomy breast reconstruction. Integra said it is working with FDA to design a post-approval study to supplement the existing data.
And in case you missed our last Medtech in a Minute report...
Accuray shared good news at the American Society for Radiation Oncology annual meeting. A study published in Frontiers in Oncology found that early-stage breast cancer patients could experience significant improvements in survival if treated with accelerated partial breast irradiation (APBI) delivered using the Accuray CyberKnife robotic radiotherapy platform.
Accuray also appears to be more proactive in its marketing of its Radixact and CyberKnife systems against other radiation therapy systems, which could help the company face competitors such as Varian Medical Systems, acquired last year by Siemens Healthineers.
Integra LifeSciences’s SurgiMend PRS Accellular Bovine Matrix (SurgiMend PRS ABDM) has been used in breast reconstruction for more than a decade under a FDA 510(k) clearance. However, an advisory panel on general and plastic surgery just voted against recommending FDA approval of SurgiMend for the specific indication of breast reconstruction. The company had submitted a PMA for the specific indication of soft tissue support in breast reconstruction surgery after mastectomy.
The advisory panel did not feel that the benefits of using the device for specific indication outweighed the risks. It’s now up to FDA to decide SurgiMend’s fate, which could have implications for patients, as the agency has not cleared or approved any surgical mesh device – whether synthetic, animal collagen derived, or human collagen derived – specifically indicated for breast reconstruction.
To help Integra Lifesciences through the next chapter will be new president and CEO Jan D. De Witte.