November 23, 2016

SentreHeart Recalls Guidewire System Due to Coating Separation

SentreHeart has issued a recall for FindrWIRZ guidewire system because the PTFE coating may separate (e.g., peel, flake, shed, delaminate, slough off) from the packaging and potentially cause serious injuries to patients.

The guidewire system is used during minimally invasive procedures in the cerebrovascular, cardiovascular and peripheral vascular systems.

There are 98 systems recalled in the U.S. and they were manufactured between Jan. 4, 2016 to July 22, 2016.

FDA Confirms a 510(k) De Novo Path for EyeGate’s Device

EyeGate has announced that it plans to pursue a marketing clearance of its EyeGate Ocular Bandage Gel (EyeGate OBG), via the de novo 510(k) pathway.

The ocular bandage gel is a synthetic biocompatible gel that coats the eye surface and is designed to resist degradation under conditions present in the eye.

“We look forward to announcing the top-line data from our PRK pilot study by the end of the year,” the company said.

FDA’s CDRH Creates Pact to Revamp Cybersecurity in Medical Devices

The FDA’s CDRH has signed a memorandum of understanding with the National Health Information Sharing and Analysis Center and the Medical Device Innovation, Safety and Security Consortium to improve data sharing on cybersecurity measures.

The collaboration is intended to create a place for stakeholders to communicate and share information about cybersecurity vulnerabilities and their effects on healthcare IT infrastructure; develop an awareness framework for improving critical infrastructure cybersecurity; and encourage stakeholders to develop innovative strategies to employ measures to address vulnerabilities.

FDA Grants Xtant Medical Clearance for Allografts

The FDA cleared the Irix-C cervical cage for use with autograft and/or allograft and the expansion of the range of levels allowable from C3-T1 to C2-T1.

Their allografts, 3Demin and OsteoSponge, will be used with Irix-C due to their ability to compress, fill and expand in the device’s graft chamber, allowing for ideal bone contact and fusion.

The Irix-C is a stand-alone cervical intervertebral fusion device intended for spinal fusion procedures at one level (C2-T1) in adult patients for treatment of degenerative disc disease.

These devices are available worldwide.

Allergan Receives FDA Clearance for the Xen Gel Stent

The FDA cleared the Xen glaucoma treatment system which consists of the Xen45 gel stent and the Xen injector, for use in the U.S.

The Xen glaucoma treatment system reduces inner eye pressure in patients, and is indicated for the management of refractory glaucoma, where previous surgical treatments have failed.