InVivo Therapeutics (NSDQ:NVIV) today released data from the 12-month follow up of the 1st patient in a pilot trial of its investigational neuro-spinal scaffold. The Cambridge, Mass.-based company’s neuro-spinal scaffold is surgically implanted following acute spinal cord injuries to act as a physical substrate for nerve sprouting. “I am delighted that our first patient continued to experience […]
Spine
European regulators recommend suspension of Medtronic’s Inductos
European regulators today recommended the suspension of Medtronic‘s (NYSE:MDT) Inductos bone growth product after inspections in July found problems with a U.S. plant that makes part of the implant. The European Medicines Agency recommended that the suspension be put in place until the problems are resolved. Dutch and Spanish inspectors found that the sponge manufacturer “did […]
SEC closes InVivo Therapeutics probe
InVivo Therapeutics (NSDQ:NVIV) said today that the U.S. Securities & Exchange Commission ended a probe of the regenerative medicine company and doesn’t plan to recommend any enforcement action. Cambridge, Mass.-based InVivo said in January that the SEC’s Boston office subpoenaed documents concerning former CEO Frank Reynolds and ex-acting CFO Sean Moran and “certain other corporate events.” Today […]
NASS 2015 Roundup: Spine trends stabilizing, new fields taking center stage
The spinal med device market appears to be stabilizing with growth in 3 key areas, according to a letter to investors published this week from Leerink Partner’s Richard Newitter, who attended the North American Spine Society’s annual meeting in Chicago last week. Newitter said the meeting was “neutral-to-positive” for firms in the spinal market, and said […]
FDA approves expanded trial for InVivo Therapeutics spinal cord treatment
InVivo Therapeutics (OTC:NVIV) said today that it won a nod from the FDA to double the enrollment in a clinical trial of its neuro-spinal scaffold. Cambridge, Mass.-based InVivo enrolled the 5th patient in the pilot study last month. Its bioabsorbable device is designed to treat acute spinal cord injuries. “I am very pleased to have come to such […]
Medtronic touts 7-year data on Prestige cervical disc
Medtronic (NYSE:MDT) said yesterday that 7-year data on its Prestige LP cervical disc showed favorable results compared to anterior cervical discectomy and fusion procedures The Prestige LP disc is indicated for single-level cervical disc disease and is designed to preserve motion in the neck, unlike fusion surgery procedures that do not allow such motion, Fridley, Minn.-based […]
Stryker wins FDA expanded clearance for VertaPlex HV
Stryker (NYSE:SYK) said yesterday it won expanded FDA 510(k) clearance for its VertaPlex HV PMMA to treat patients with sacral insufficiency fractures. Sacral insufficiency fractures are an under diagnosed condition often occurring in the elderly population, the Kalamazoo, Mich.-based company said. “Careful intraoperative technique and VertaPlex HV PMMA is an excellent and safe solution in […]
NuVasive wins FDA nod for X-Core cervical corpectomy cage
NuVasive Inc. (NSDQ:NUVA) said today that it won 510(k) clearance from the FDA for its X-Core mini cervical corpectomy cage, claiming it as the 1st such device cleared for the U.S. market. The X-Core device is designed to replace vertebrae in the cervical spine (C3 to C7), San Diego-based NuVasive said. It must be used with […]
Vertera Spine wins FDA nod for porous PEEK fusion device
Vertera Spine said yesterday it won FDA 510(k) clearance for its porous PEEK Cohere cervical interbody fusion device. The Cohere device is composed entirely of Vertera Spine’s novel PEEK Scoria porous biomaterial which the company said is more durable than metal coatings and 2 times stronger under shear loading than trabecular bone. “The FDA clearance […]
Implanet wins expanded FDA 510(k) for Jazz band device
French orthopedic implant company Implanet said Wednesday it won expanded FDA 510(k) clearance for its Jazz spinal implant allowing it to be used with other posterior thoraco-lumbar fixation systems. The Jazz implant is intended to provide temporary stabilization as a bone anchor during bone fusions and to aid in the repair of bone fractures. The […]
Plaintiff takes Infuse case against Medtronic to the Supreme Court
The plaintiff in a product liability lawsuit asked the U.S. Supreme Court to take up the case, involving alleged off-label promotion of Medtronic‘s (NYSE:MDT) controversial Infuse bone-growth protein. Patricia Caplinger wants the high court to review an April decision by the U.S Court of Appeals for the 10th Circuit that her state-law tort claims are preempted by federal law. Caplinger […]