Briefs

FDA Approves Device for Prevention of Recurrent Strokes

The FDA has approved the Amplatzer PFO Occluder device, which reduces the risk of a stroke in patients who previously had a stroke believed to be caused by a blood clot passing through a small hole in the heart, called a patent foramen ovale, and then traveling to the brain.

The Amplatzer PFO Occluder is inserted through a catheter that is placed in a leg vein and advanced to the heart. It is then implanted close to the hole in the heart between the top right chamber and the top left chamber.

The safety and efficacy was assessed study with 499 participants aged 18 to 60 years old who were treated with the Amplatzer PFO Occluder plus blood-thinning medications compared to 481 participants who were treated with blood-thinning medications alone. The study found a 50 percent reduction in the rate of new strokes in participants.

FDA Delays Phase III Trial of Inovio’s DNA Vaccine, Delivery Device

The FDA has placed a clinical hold on a proposed Phase III trial of Inovio Pharmaceuticals’ VGX-3100, a synthetic DNA vaccine being studied in cervical dysplasia because of questions on the delivery device for the drug. The Cellectra 5PSP immunotherapy delivery device is designed to administer DNA immunotherapies directly into muscle tissue.

Inovio estimated that the start of the Phase III trial could be delayed until at least the first half of 2017, pending a resolution, and expects a full formal letter from the FDA within the next 30 days.

FDA Wants Input on PMA Information Collection

The FDA asked for public comments on the burden imposed by information collection requirements for premarket approval of Class III medical devices.

The FDA estimates the annual reporting burden to be 350,562 total hours, involving 4,846 respondents.

Comments are due 60 days from the publication of the Federal Register announcement, which is available at www.fdanews.com/10-18-16-premarketapproval.pdf.

Amniox Announces Improved Outcomes with Clarix Regenerative Matrix Treatment

Amniox published the results of a prospective randomized clinical study of its proprietary cryopreserved Amniotic Membrane (AM) as an adjunct to lumbar discectomy.

The study included 80 patients, with half of the patients receiving Clarix 100 in the disc space following removal of the disc herniation and half receiving the standard of care, which involved removal of the herniation alone.

“These results indicate that the application of Clarix can influence the healing response to significantly improve post-surgical outcomes. Patients experience reduced pain and a faster and sustained return to activities of daily living,” the company said.

FDA Grants Four Emergency Use Authorizations for Zika Diagnostics

The FDA has issued Emergency Use Authorizations for four in vitro diagnostic devices for detection and/or diagnosis of Zika virus in response to outbreaks in the Americas.

Authorizations were granted for Siemens Healthcare Diagnostics, Luminex, InBios International and Roche Molecular Systems.

The authorizations follow a Feb. 26 determination by the HHS secretary that there is a significant potential for a public health emergency involving the Zika virus.

RTI Surgical Gains Additional 510(k) Clearance for Streamline OCT System

RTI Surgical has received 510(k) clearance for the Streamline OCT Occipito-Cervico-Thoracic System.

This clearance expands the indication for polyaxial screw placement to include the cervical spine, and also includes clearance for a dual-diameter transition rod.

In addition, levels of fixation can be accomplished by connecting to other RTI pedicle screw systems through the newly cleared transition rod or currently available rod-to-rod connectors.

FDA Releases Labeling Guidance on Tubal Implant Devices

New FDA guidance identifies the content and format for certain labeling components for permanent, hysteroscopically placed tubal implant devices intended for female sterilization.

The guidance applies to all devices of this type, regardless of the insert material composition, location of intended implantation, or exact method of delivery. It specifies inclusion of a boxed warning and patient decision checklist.

The guidance can be read here: www.fdanews.com/10-28-16-guidance.pdf.

Quidel Receives FDA Clearance for Solana(R) Strep Complete Assay

Quidel has received 510(k) clearance from the FDA to market Quidel’s new Solana Strep Complete Assay for the rapid and qualitative detection and differentiation of Streptococcus pyogenes (Group A beta-hemolytic Streptococcus) and Streptococcus dysgalactiae (pyogenic Group C and G beta-hemolytic Streptococcus) nucleic acids isolated from throat swab specimens obtained from symptomatic patients.

The device can process up to 12 patient samples in each 25-minute run.

Spineology Gains FDA Clearance of Rampart Duo Interbody Fusion System

Spineology has received FDA clearance for the Rampart Duo Interbody Fusion system.

The device design includes PEEK spacer blocks that are positioned at each end of the device and a flexible porous graft containment mesh that creates a central graft cavity.

After implanting, the porous graft containment mesh is filled with bone graft to release the device in the anterior-posterior direction and in the superior-inferior direction to provide conforming apposition with the vertebral endplates.

“The implant design allows for decreased retraction requirements when compared to current interbody systems. The minimized tissue retraction may reduce the potential for nerve damage and resultant leg pain associated with the lateral approach,” the company said.

FDA Issues Form 483s to Hospitals for Failing to Report Adverse Device Events

The FDA has issued Form 483s to 11 hospitals for failing to report adverse events related to the use of morcellators and contaminated duodenoscopes.

The FDA will hold a public workshop Dec. 5 to solicit input and advice on improving hospital-based surveillance systems and the broader role of using hospitals to evaluate how well devices work in the clinical setting.

A summary of the inspections and links to the Form 483 are available here: www.fdanews.com/10-27-16-hospitalinspections.pdf.