Medtronic (NYSE:MDT) touted data today showing that intrathecal baclofen therapy delivered via the company’s SychroMed II infusion pump performed better than the conventional treatment for patients with severe post-stroke spasticity.
The medtech titan’s SynchroMed II pump is the only device approved in the U.S. for ITB therapy.
The Sisters study pitted Medtronic’s ITB therapy against oral antispastic medications for the treatment of post-stroke spasticity. The trial’s primary outcome was change in muscle tone and spastic hypertonia from baseline to six months.
Researchers found that ITB therapy demonstrated a significant improvement over oral drugs in reducing muscle tone in the affected lower and upper extremities, according to Medtronic. The group of patients who received ITB therapy saw improvement to their total functional improvement scores after six months, while patients in the comparison arm saw their scores worsen.
24 out of 25 patients in the ITB group reported adverse events, compared to 22 out of 35 patients in the control arm. Events were generally consistent with the known safety profile of ITB therapy, Medtronic noted, and no patient stopped treatment due to adverse events.
“ITB Therapy is underused when it comes to treating severe spasticity in post-stroke patients,” lead author and study investigator Michael Creamer said in prepared remarks. “The study results demonstrate that ITB Therapy is superior to oral medications in decreasing muscle tone.”
“All over the world, PSS patients are suffering from inadequately managed severe spasticity that can interfere with their quality of life,” Charlie Covert, VP and GM of Medtronic’s, targeted drug delivery division, added. “At Medtronic, we’re committed to raising awareness of ITB Therapy as an effective treatment for severe PSS and to ensure it is available to the patients who need it most.”