NuVasive wins expanded FDA nod, launches interbody fusion devices

January 4, 2018 By Fink Densford Leave a Comment

NuVasive Inc. (NSDQ:NUVA) said today it won expanded FDA 510(k) clearance for its Cohere cervical interbody fusion device and that it launched the Coalesce thoracolumbar interbody fusion device.

Both the launch and updated clearance comes from the company’s acquisition of Vertera Spine, which it closed last September.

The Cohere and Coalesce implants use porous version of the material polyetheretherketone, or PEEK, and are designed to provide three-dimensional achitecture to elicit and encourage bone growth, San Diego, Calif.-based NuVasive said.

“Our strategy in building our AMS portfolio is to provide unprecedented, innovative technologies that enhance the surface, structure and visualization properties of these implants. Our launch of Coalesce and the expanded clearance of Cohere and Coalesce are all part of our continued commitment to bring disruptive technology to market and investment into our comprehensive AMS portfolio, which converge to provide a better surgical experience and improve patient quality of life,” chair & CEO Gregory Lucier said in a prepared statement.

The company said that the Coalesce device is now available for TLIF and PLIF procedures in multiple footprints, heights and lordotic options. Its indications include use for one or two adjacent levels in the thoracolumbar spine with both autograft and allograft for treating degenerative disc disease and degenerative spondylolisthesis and multi-level degenerative scoliosis.

NuVasive said that the expanded FDA indications for its Cohere device clear it for use at multiple levels in the cervical spine with both autografts and allografts.

“Patients can gain significant pain relief and improved functional outcomes through the stabilization and fusion of the degenerated spinal motion segment. Cohere and Coalesce contribute to these outcomes by retaining the biomechanical properties necessary for intradiscal spinal applications, while helping facilitate osseointegration and bone growth. The use of these new Porous PEEK implants may enhance fusion and limit the risk of stress-shielding, subsidence and implant failure,” Dr. Kenneth Burkus of The Hughston Clinic said in a press release.

Last month, NuVasive said it inked a deal to acquire intraoperative neurophysiological monitoring service provider SafePassage for an undisclosed amount.

Siemens Healthineers lands FDA clearance for two CT systems
Siemens Healthineers this week said it won FDA clearance for its Somatom go.Sim and Somtom go.Open Pro computed tomography systems. The CT systems are designed for radiation therapy planning and are members of the company’s Somatom go. platform of devices. Siemens Healthineers’ platform uses hardware and software components like patient marking lasers and automated quality… […]
Protolabs’ healthcare grant spurs 2 feeding tube inventions
Digital manufacturer Protolabs (NYSE:PRLB) announced today that MedStar Health (Columbia, Md.) and Cleveland Clinic Innovations are joint winners of the company’s Cool Idea Award: Healthcare Grant. These grants provide in-kind manufacturing services to the support development of medical products to spur innovation in the field. MedStar Health’s gravity-feed syringe holder simplifies the feeding of newborns who spend […]
Sterigenics’ legal troubles mount in Illinois
Nearly two dozen new lawsuits were filed against Sterigenics this week over its now-shuttered ethylene oxide (EtO) sterilization plant in Willowbrook, Ill., according to a law firm representing some of the plaintiffs. That brings the total of such lawsuits to nearly 75, noted Chicago personal injury lawyer Antonio Romanucci, court-appointed lead counsel from among five… […]
In2Bones launches AlloAid BioNail
In2Bones this week launched its AlloAid BioNail sterile allograft implant. The implant is designed to give rigid, stable fixation during hand and foot reconstruction. AlloAid BioNail is made from strong cortical allografts to provide osteoconductive properties for bone remodeling and healing. It features a tapered point and multiple, contoured wedge facets to ease insertion, anchor… […]
Protolabs’ healthcare grant spurs 2 feeding tube inventions
Digital manufacturer Protolabs (NYSE:PRLB) announced today that MedStar Health (Columbia, Md.) and Cleveland Clinic Innovations are joint winners of the company’s Cool Idea Award: Healthcare Grant. These grants provide in-kind manufacturing services to the support development of medical products to spur innovation in the field. MedStar Health’s gravity-feed syringe holder simplifies the feeding of newborns… […]
Nihon Kohden launches new patient monitor
Nihon Kohden (TYO:6849) announced the U.S. launch of its Life Scope SVM-7200 series vital signs monitor for outpatient facilities and beds that aren’t continuously monitored. The Life Scope SVM-7200 is designed to provide customizable early warning scoring to help clinicians identify patients who are deteriorating or at risk of deterioration. It combines vital signs data with… […]
Senate confirms Dr. Stephen Hahn to lead FDA
The U.S. Senate has confirmed Dr. Stephen Hahn as the next commissioner of the FDA. The vote was 72 to 18, according to a report in the New York Times. Hahn will be the first permanent commissioner of the agency since Dr. Scott Gottlieb resigned in April. President Trump nominated Hahn, the chief medical officer at Houston’s… […]
3M to sell drug-delivery biz to Altaris Capital Partners for $650m
3M (NYSE:MMM) announced today that it entered into an agreement to sell most of its drug-delivery business to an affiliate of Altaris Capital Partners for approximately $650 million. St. Paul, Minn.-based 3M will retain its transdermal drug delivery components business, according to a news release. The business being divested has annual global sales reaching approximately… […]
Lawsuit endangers Sterigenics consent order in Georgia
A consent order that Sterigenics entered into with the state of Georgia to reduce ethylene oxide (EtO) emissions at its Atlanta medtech sterilization plant may be in jeopardy. A hearing is scheduled today on a lawsuit that accuses the Georgia Environmental Protection Division (EPD) of failing to take public comment before entering the Aug. 7… […]
Trelleborg acquires Tritec Seal
Trelleborg Sealing Solutions said today it has closed on its acquisition of rotary seal manufacturer Tritec Seal, which produces engineered polytetrafluoroethylene (PTFE) sealing solutions. Trelleborg said the acquisition strengthens its product portfolio while giving the business area access to increased manufacturing capacity. Headquartered in Fenton, Mich., with additional manufacturing in Giddings, Texas, Tritec Seal generated… […]
RSNA 2019: 7 radiology innovations you need to know
Nearly 53,000 people attended the 2019 Radiological Society of North America annual meeting in Chicago last week. And they heard the same acronym over and over again: AI. Exhibitors at the conference touted their artificial-intelligence-enhanced technology at every turn, claiming to make images clearer, sharper, easier to use and powerful enough to help clinicians make… […]