Orthofix International N.V. won CE Mark approval from the European Union for its Advent cervical disc.
The McKinney, Texas-based company, which has operations in Boston, said it plans to begin marketing the device in Europe during the fourth quarter.
It’s also running a study of the Advent disc, involving 100 patients in 15 medical centers, ahead of seeking similar approval from the U.S. Food & Drug Administration. Orthofix plans to add 10 more study sites in the U.S. this year, taking the total number of enrolled patients to 450.
ConforMIS Inc. raised $50 million from a group of private and government investors.
The Burlington partial knee implant maker, which developed technology to manufacture surgical implants and instrument custom-made to patients’ physiology, said the Series D round came from private equity firms led by prior investor Aeris Capital and the sovereign funds of foreign governments including Singapore and Kuwait.
A few months after settling federal allegations that they ran kickback schemes, five orthopedic device makers say their new procedures ensure that their interactions with surgeons are transparent, above-board and, above all, absolutely necessary to the development of new devices and technologies.
Bone growth biologics were used in about 25 percent of all U.S. spinal fusion surgeries in 2006, caused more frequent complications and cost more, according to a study in the Journal of the American Medical Assn.
That’s bad news for Medtronic and Stryker Biotech, which make the BMPs examined in the study of more than 328,000 patients undergoing spinal fusion procedures from 2002 to 2006.
It showed that BMP usage increased from 0.69 percent of all fusions in 2002 to 24.89 percent in 2006 and cost between 11 percent and 41 percent more than spinal fusions performed without it.
Aquamer Medical Corp. is sinking away for good.
The tiny medical device company, unable to find a market for its injectable hydrogel products, is planning to merge with an online-search startup and will become Kwick Search Corp.
The change-over is expected to close by the end of the summer, CEO Marshall Sterman told MassDevice.
The Raynham orthopedics maker, a Johnson & Johnson subsidiary, and Biedermann Motech GmbH sued Medtronic in 2001, accusing it of violating a spinal surgery screw patent DePuy licensed from Biedermann with its now-discontinued Vertex line of multiaxial screws (Medtronic markets the Vertex Select system these days).
The Burlington-based company said a patient in Germany is already using the device, after a June 18 procedure to implant the patient-specific, bicompartmental resurfacing knee replacement device.
Synthes subsidiary Norian Corp. faces 52 felony counts, including conspiracy to obstruct the Food & Drug Administration and “to commit crimes against the United States,” according to a Justice Dept. release. The company was also slapped with seven counts of making false statements in an FDA investigation and 44 counts of releasing “adulterated and misbranded” shipments of its Norian XR cement “with intent to defraud.”
If you like so-called “baby carrots,” a new treatment launched by HydroCision Inc. might be of interest.
The Billerica-based surgical waterjet maker’s SpineJet system aims to use technology similar to that used to trim carrots down to size: A high-pressure jet of water.
The treatment is an outpatient procedure, performed under local anesthesia, in which a surgeon uses the waterjet to make a tiny incision in the fibrous outer ring of a vertebral disc, the annulus, and remove some of its pulpy nucleus to relieve the pressure that causes bulging and herniated discs.
The U.S. Patent Office approved a seventh patent by NuOrtho Surgical, for a low-energy radio-frequency application.
President and CEO Jeff Morrill tells MassDevice the patent is applicable to an electrosurgical device the company is developing for arthroscopic procedures.
“Our early products will be for debridement or contouring,” Morrill said. “This patent is for a future product … around agent delivery and particularly bone fusion.”
NuOrtho said it’s initially targeting the U.S. and hopes to find partners to expand into the European Union. The company recently launched a Series B investment round.