Centinel Spine said yesterday it won Australian Therapeutic Goods Administration clearance for its Stalif L no-profile lateral lumbar integrated interbody system. Centinel Spine touts the Stalif L as the only lateral device to offer a no-profile, compressive lag fixation device with proprietary anti-backout technology and 12-degrees of lordosis, as well as a large chamber for bone […]
Spine
Trial slated in wrongful death suit over Norian XR bone cement
A state court in Washington is slated next week to hear the 1st trial in a group of civil lawsuits filed by the families of patients who died on the operating table minutes after injection with the Norian XR bone cement then made by now-Johnson & Johnson (NYSE:JNJ) subsidiary Synthes. At least 5 patients died during […]
Nevro takes a hit after insurers deem Senza therapy experimental
Shares in Nevro (NYSE:NVRO) took a hit yesterday after investors learned that a pair of insurers in Pennsylvania and Tennessee tagged therapy using its Senza spinal cord stimulation device as experimental. The Senza device, which won an FDA nod in May 2015, is designed to deliver high-frequency electrical impulses of up to 10,000Hz to the spinal cord to avoid the […]
Si-Bone raises $20m for iFuse spine implant
UPDATED June 20, 2016 with comment from Si-Bone, investor details. Si-Bone said June 17 that it raised a $20 million funding round, hot on the heels of the regulatory and reimbursement wins it logged last week. Nine investors participated in the equity round, San Jose, Calif.-based Si-Bone said in a regulatory filing; in a June 20 press release, the […]
SpineGuard wins FDA nod for PediGuard threaded DSG device.
SpineGuard (EPA:ALSGD) said today it won FDA 510(k) clearance for its PediGuard threaded Dynamic Surgical Guidance device designed for pedicle screw insertion. The PediGuard device is available in various designs, the company said, to accommodate both surgeon’s preferences and patient anatomies. “We are very excited by the clearance of our PediGuard Threaded device, which brings […]
Titan Spine touts implant warranty program
Titan Spine said yesterday it is expanding its spinal device warranty to include free replacement if its Endoskeleton interbody fusion devices delaminate or generate particulate debris during implantation. The Mequon, Wisc.-based company said it amended its warranty, which it launched in 2014, based on its “confidence in its proprietary subtractive manufacturing process. “Since we 1st announced […]
NuVasive’s $28m loss to distributor in sales poaching case stands
A federal judge in California rejected a bid by NuVasive (NSDQ:NUVA) to overturn its $28 million loss in a sales poaching lawsuit with 1 of its distributors. Earlier this year a jury in the U.S. District Court for Southern California awarded $41.8 million to Nevada-based distributor Madsen Medical, which had sued San Diego-based NuVasive in September 2013, after being […]
Study: Insurance restrictions on lumbar fusions push procedure volumes down
An insurance policy limit on lumbar fusion procedures helped slash costs and medically unnecessary surgeries in North Carolina, and the approach could work nationally, according to new research published in the journal Spine. “The commercial insurance policy change had its intended effect of reducing fusion operations for indications with less evidence of effectiveness, without changing […]
Study shows no increased cancer risk with Medtronic’s InFuse
A study of nearly 17,000 patients who had spine fusion procedures showed no increased cancer risk with the InFuse bone-growth protein made by Medtronic (NYSE:MDT). The retrospective cohort study, published online last week in the journal Spine, used data from the Washington State Comprehensive Hospital Abstract Reporting System, the Washington State Cancer Registry and death certificates from […]
Zimmer Biomet to drop $1B on spine-focused LDR Holding
Zimmer Biomet (NYSE:ZBH) said today it is buying spinal medical device company LDR Holding for approximately $1 billion. Boards from both companies approved the acquisition agreement, the company said, with Zimmer Biomet slated to acquire all outstanding shares of LDR at $37 per share in cash. The company expects the deal to close in the 3rd […]
First Ray wins FDA nod for SpeedButton soft-tissue-to-bone attachment device
Startup surgical device developer First Ray said today it won FDA 510(k) clearance for its SpeedButton system designed to attach soft tissue to bone. The SpeedButton device attaches soft tissue to bone through a transosseous fixation technique to attach to the cortical bone opposite the soft tissue reattachment site, the Logan, Utah-based company said. “The […]