For you hard-core spinal device folks who couldn’t make the long trip to Vancouver, here are a few items of potential interest from the most recent ASTM standards committee meeting. Of the 50-plus attendees, several spine companies with a local presence were represented, including DePuy Spine, Facet Solutions and Orthofix Spinal Implants.
Orthopedics
Welcome to MassDevice's Orthopedics Hub, your resource for the latest in orthopedic news. Stay informed about the innovations and business news shaping the ortho device industry.
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Implants | Metal-on-Metal | Spine
Here are the top orthopedic device features from MassDevice and its sister publications (and scroll down to read the latest cardiology device news from MassDevice):
+ The biggest stories from AAOS 2024
+ The 10 largest orthopedic device companies in the world
+ The ZimVie Tether helps kids with scoliosis — if they can get it in time
+ Could 2023 be a boom year for orthopedic devices?
+ The top orthopedic device news out of AAOS 2023
🎙️ Tune in to the Ortho Innovation Talks podcast on the DeviceTalks podcast network.
Latest Orthopedics News
Confluent Surgical’s Duraseal in line for another nod from the FDA
Confluent Surgical Inc.‘s Duraseal Xact Sealant System is line for Food & Drug Administration approval for use in spinal surgeries, the Reuters news service reported.
The federal watchdog agency said the Waltham-based biomaterial product developer’s polymer-based sealant, designed to be sprayed into a surgical site to provide a watertight seal, is better than other options for preventing leaks after spinal procedures. Duraseal is already approved for use in cranial surgeries.
Orthofix chisels away at its debt during the first quarter
After rebuffing a bruising proxy challenge from insurgent stockholders in April, Orthofix International NV got down to paying off some of the debt that caused the ruckus in the first place.
The McKinney, Texas-based orthopedic device manufacturer, which has operations in Springfield and Boston, said it paid down about $15 million in debt, including a $3 million payment it made ahead of schedule.
Orthofix board member Hewitt to step down
Peter Hewett, a board member at Orthofix International NV for 17 years, is stepping down.
Hewett, 73, joined the McKinney, Texas-based orthopedic device manufacturer’s slate of directors in 1992. Orthofix also runs offices in Boston and a production facility in Springfield.
ApaTech: Synthetic bone graft works as well as ICBG in two trials
Etex Corp.’s bone sub materials get another 510(k)
The Food & Drug Administration cleared Etex Corp.‘s orthopedic putty for use in small-bone repairs.
The Cambridge biotech said the federal watchdog agency gave the nod to 1cc and 5cc sizes of its Beta-bsm injectable paste and Gamma-bsm moldable putty, on top of existing clearances for the 5cc and 10cc sizes.
The bone substitute materials are used to make osteo-conductive scaffolds that ape the nanocrystalline structure of human bone. The smaller sizes were developed for hand and foot/ankle surgeries. The products are used to fill voids in bone that the bone doesn’t depend on for stability.
Orthofix extends Novation supply deal
Orthofix International NV inked a three-year extension of its contract to supply bracing products to Novation, a healthcare services contractor.
Novation provides healthcare services to the hospital network VHA Inc., the University HealthSystem Consortium and the Provista group purchasing organization.
Orthofix expects slight Q1 sales growth, earnings dip
Orthofix International NV‘s preliminary first-quarter revenues and earnings numbers indicate flat sales and a slight dip in the bottom line, compared with the same period last year.
The McKinney, Texas-based orthopedic device manufacturer, which has a presence in Boston, said it expects sales for the three-month period ended March 31 to be around $129 million, compared to $128 million for the same period last year.
Orthofix named in a false claims complaint—again
Orthofix International is one of the companies named in a whistleblower lawsuit accusing the group of bone-growth stimulator manufacturers of reimbursement fraud.
It’s not the first time the Boston-based orthopedics maker has run afoul of federal authorities and the False Claims Act. In 2003, the company agreed to pony up nearly $1.6 million to settle allegations that it submitted false claims to TRICARE, the military’s healthcare program.
Third Stryker Biotech rep cops plea in off-label promotion case
U.S. Attorney Michael Sullivan is making his last week on the job a busy one.
Just five days before he leaves public service for the oak-trimmed corridors of private practice, Sullivan announced a third guilty plea in the federal investigation of off-label promotion by former sales reps for Stryker Biotech.
FDA spikes wider use of Stryker’s OP-1 putty
The federal Food & Drug Administration shot down Stryker Corp.‘s application for expanded use of its bone-growth putty after a panel of outside experts voted 6-1 against allowing the expansion, the Reuters news service reported.
The watchdog agency’s panel found that bias may have influenced subjects in clinical trials for the medical device giant’s OP-1 putty, a genetically engineered protein used to stimulate bone growth in spinal surgeries.
Stryker’s biotech division is headquartered in Hopkinton.