St. Jude Medical Lands Pair of International Device Approvals

St. Jude Medical Inc. can boast the industry’s first and only regulatory approval for an implanted neurostimulation device for chronic migraine headaches. The St. Paul, Minn.-based company announced a it received European CE Mark approval for its Genesis implanted neurostimulation device for patients with chronic migraines.

Genesis, according to the company, provides peripheral nerve stimulation (PNS) to the occipital nerves to manage migraines. Small electrical leads are placed under the skin and connected to a device which produces pulses of stimulation.

St. Jude’s PNS evaluation study, the largest clinical study evaluating PNS as a treatment for chronic migraine, found that 65 percent of patients reported excellent or good pain relief at one year and 88 percent said they would require the procedure to a friend.

“Through my participation in this study, I have observed the life-changing potential this therapy offers chronic migraine patients,” said principle investigator Stephen Silberstein, M.D.

“For more than six years we have worked with our investigators to develop and evaluate this life-changing therapy,” said Chris Chavez, head of St. Judes neuromodulation division, said in the press release. “We will continue to work with regulatory authorities to secure approvals in order to offer this therapy option to patients throughout the world.”

The company also scored a second regulatory win with approval in India of a quadripolar pacing system for cardiac resynchronization therapy defibrillators (CRT-Ds). Cardiac resynchronization therapy, which can be delivered in an implantable cardioverter defibrillator (ICD) or a pacemaker, resynchronizes the beating of the heart’s lower chambers (ventricles), which often beat out of sync in heart failure patients.

St. Jude’s Promote Quadra CRT-D device allows physicians to address pacing complications without surgically repositioning a CRT lead. Quadra uses four electrodes that can form 10 pacing configurations so doctors can pace around scar tissue and avoid other common CRT complications, according to the company.

“High pacing thresholds and phrenic nerve capture have been major problems with LV leads. This new quadripolar LV lead offers different pacing vectors and helps us to choose a vector which is devoid of Phrenic nerve capture. Altering pacing polarity may offer a lower pacing threshold, which is likely to improve the battery longevity,” said Dr. Calumbur Narsimhan, Director of Arrhythmia-Electrophysiology Services at CARE Hospital in Hyderabad.

The Promote Quadra CRT-D and Quartet pacing lead have both received European CE Mark approval.