Medtronic scores FDA approval for next-gen artificial cervical disc

(Medtronic)

Medtronic ($MDT) won FDA approval for its next-generation artificial disc for adult patients with neck pain or spinal cord injuries. The news is a feather in the company’s cap as it charges ahead with R&D.

The Dublin-based company’s Prestige LP Cervical Disc is approved to treat patients who have cervical disc disease caused by nerve or spinal cord compression at two neighboring levels between the C3-C7 segments of the neck. Unlike fusion surgery, also known as anterior cervical discectomy and fusion (ACDF), the disc allows motion in the neck following an operation.

Medtronic is talking up its device as an improvement over the current standard of care. The disc is the first to be ruled as safe and effective for one- and two-level procedures, and is the first on the U.S. market to be proven statistically superior in overall success for the procedures, the company said in a statement.

“Medtronic is committed to elevating spine care by combining innovative new technologies with clinical evidence,” Doug King, SVP of Medtronic’s Spine division, said in a statement. “The Prestige LP Disc is a superior alternative to ACDF and an important motion-preserving option for physicians treating certain patients suffering from two-level cervical disc disease.”

Regulators based their approval on two pivotal clinical trials, including a two-level clinical trial with 397 patients at 30 sites in the U.S. The study showed that after two years, patients who received Prestige were better off than patients who were treated with ACDF.

Meanwhile, Medtronic is charging ahead with R&D. The company recently said that it’s “two or three years” ahead of its competition on an artificial pancreas, Medtronic Diabetes EVP Hooman Hakami said in June.

Medtronic is also working on an internal robotic surgery program. In May, the company struck a deal with Israel’s Mazor Robotics ($MZOR) to gain some ground in the field.

- read the statement

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