St. Jude Medical Inc. (NYSE:STJ) announced today that it won U.S. Food & Drug Administration clearance for its Epiducer lead delivery system for neurostimulation in treatment of chronic pain.
The clearance is the first of its kind for the U.S. The device allows physicians to place multiple neurostimulation leads and different types of leads through a single entry point, reducing the need for the multiple incisions typically required.
The device also allows a physician to implant STJ’s S-series paddle leads, which previously required a more invasive surgery that typically means removal of part of the vertebral bone.
Health Benefit Consultants, Share Your Expert Insights in Our Survey
MassDevice Staff Website The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
Neurostimluation, or spinal cord stimulation, sends mild electrical impulses via a lead that is placed near the spine to interrupt or mask pain signals on their way to the brain. The treatment is typically used to manage chronic pain in the trunk or limbs, and often in treatment of failed back surgeries.
St. Jude is also experimenting with using deep-brain stimulation for the treatment of another kind of pain – depression.
The St. Paul, Minn.-based company’s systems compete against some of the biggest players in the med-tech arena. Medtronic Inc. (NYSE:MDT), who won CE Mark for a fully implantable peripheral nerve stimulation device in May 2011. Boston Scientific Corp. (NYSE:BSX) won FDA clearance for its lead system in August 2010.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
The Massachusetts Medical Devices Journal is the online journal of the medical devices industry in the Commonwealth and New England, providing day-to-day coverage of the devices that save lives, the people behind them, and the burgeoning trends and developments within the industry.
