Medical Device Daily Associate

Medtronic (Minneapolis) reported that it received FDA approval, via a premarket approval application, for its SynergyPlus+ neurostimulation system for chronic pain.

The new device is the newest “pain pacemaker” to join its family of implantable chronic pain therapies. It was designed to give patients more control over the delivery of stimulation that blocks pain signals from reaching the brain while performing a variety of daily activities. The previous generation of the Synergy has only one program option.

The company said this advancement allows it to better meet the growing needs of chronic pain patients and their physicians.

Kyra Schmitt, a spokesperson for Medtronic, told Medical Device Daily that with this new system, for the first time “you can customize your therapy.” She said that new device may eventually supplant the original Synergy system, but not in the foreseeable future.

The company said the SynergyPlus+ has the greatest number of program options (up to 26) available of any non-rechargeable neurostimulation system on the market today. Using a small, hand-held remote control programming device, patients can choose among multiple settings that are preset by a physician to address pain levels associated with different daily tasks, such as standing, walking or laying down.

“Because chronic pain affects each person differently, it’s important to have a range of therapies designed specifically to treat the individual needs of any patient,” said Alon Mogilner, MD, director of functional and restorative neurosurgery at North Shore University Hospital (Manhasset, New York).

“SynergyPlus+ is the right choice for many of my patients who require low to moderate levels of stimulation to control their pain,” he added.

According to the company, about 25% of the U.S. population, more than 70 million people, experience some form of chronic pain. Many remain unaware of the range of available treatment options.

It is estimated that chronic pain accounts for an estimated $100 billion per year in medical costs, including 515 million lost workdays and 40 million physician visits.

Medtronic said that the device’s array of program options provides a level of therapy customization that may result in fewer physician follow-up visits, which can otherwise be required to ensure that the most effective amount of stimulation is delivered over time. In addition, the device is the only system with diagnostic capabilities that allow physicians to assess the way patients use the system to fine-tune delivery of pain-blocking stimulation.

Defined as pain that persists or recurs for more than six months, chronic pain can be caused by a variety of injuries and diseases, and most commonly affects the lower back and legs. Left untreated or under-treated, chronic pain can destroy a person’s quality of life. Beyond the physical disability that often results, it can lead to difficulty holding a job, low self-esteem, strained relationships, depression and suicide.

The system is indicated as an aid in the management of chronic, intractable unilateral or bilateral pain of the trunk and/or limbs that is associated with failed back syndrome, low back syndrome or failed back, radicular pain syndrome, post laminectomy pain, multiple back operations, unsuccessful disc surgery or degenerative disc disease, peripheral causalgia, epidural fibrosis, arachnoiditis or lumbar adhesive arachnoiditis, and complex regional pain syndrome.

Schmitt said the same basic technology that is found in the SynergyPlus+ is being applied to another device being developed for use in the treatment of chronic migraines. “It’s the same basic principle using the Synergy system, but the way the electricity is delivered [and] the types of leads used is different,” she said.

The neurostimulator version of the Synergy delivers electrical impulses via insulated lead wires tunneled under the skin near the occipital nerves at the base of the head. That device is still under investigation.

Medtronic also reported this week that it has begun a clinical study to evaluate the company’s Adapta pacemaker, which promotes natural heart activity for patients with a slow heart rhythm.

Within the next year, the company said it expects to introduce a portfolio of fully automatic pacemakers, the Adapta, Versa and Sensia, in countries worldwide. These pacing systems are designed to provide physiologic pacing adapted to the needs of individual patients.

The first Adapta pacemaker implants were conducted by associate professor Goran Milasinovic, MD, PhD, of the Clinical Center of Serbia (Belgrade, Serbia); Johannes Sperzel, MD, of the Kerckhoff-Klinik (Bad Nauheim, Germany); and professor Karlheinz Tscheliessnigg, MD, at Universitatsklinikum Graz (Graz, Austria).

The clinical study is a prospective, non-randomized, multi-center trial, involving up to 120 patients at 10 sites, to evaluate the safety and clinical performance of the Adapta pacing system.

The Adapta pacemaker offers a pacing mode called managed ventricular pacing (MVP), which enables the device to be programmed to deliver pacing pulses to the heart’s lower right chamber (ventricle) only when necessary, often less than 2% of the time. Other dual-chamber pacemakers often pace the right ventricle 90% or more of the time, the company said.

The company said that recent clinical studies have suggested that reducing this pacing stimulation may reduce the patient’s risk of developing heart failure and atrial fibrillation.

“By reducing unwarranted ventricular pacing, we hope to reduce incidences of heart failure hospitalization,” said Milasinovic, coordinating clinical investigator of the evaluation. “The Adapta’s therapeutic features may enable physicians to better manage the co-morbidities that typically befall bradycardia patients.”

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