St. Jude Medical Announces MHLW Approvals Of The Proclaim Elite MRI, A Patient-Centric And Recharge-Free Chronic Pain Treatment Option And New SCS Trial System - The Industry's First SCS Systems To Incorporate Apple Digital Devices enabling Japanese inter

By prioritizing convenience, comfort and pain relief, the Proclaim Elite MRI SCS System aims to shift patient focus from their chronic pain therapy toward their quality of life

St. Jude Medical Japan Co., Ltd., a medical device company, recently announced approval from the Japanese Ministry of Health, Labor and Welfare (MHLW) of the new recharge-free Proclaim Elite MRI Spinal Cord Stimulation System for patients suffering from chronic pain in Japan. The approval also includes conditional magnetic resonance (MR) labeling for the Proclaim Elite MRI system, which will allow patients receiving spinal cord stimulation (SCS) to safely undergo head and extremity MRI scans.

The current approval also includes the company’s new, innovative clinical programmer with Apple technology. Rather than a complex controller, the St. Jude Medical Proclaim Elite MRI provides patients with a more intuitive iPod touch mobile digital device as a controller, while physicians will utilize an iPad mini mobile digital device to program and adjust their patient’s spinal cord stimulation therapy. It is the first interfacing patient controller written in the Japanese language among currently-approved neuromodulation devices in Japan.

“Incorporating Apple mobile digital technology into the Proclaim Elite MRI spinal cord stimulation is a pivotal step. Removing the need to hold a programming wand over the implanted generator will reduce the burden on patients as well as for clinicians. Moreover, incorporating Japanese in the interface will make it easier for patients to use the controller. With the introduction of this new SCS system, we can expect to see a marked improvement in therapy compliance as well as the quality of life for the patient.” said Dr. Takeshi Uno of Junwakai Memorial Hospital. “It is good news that this recharge-free SCS system comes in a size that fits relatively smaller anatomies of Japanese patients, without compromising functionality or battery longevity. This is a major advantage to patients, especially those who work or patients who may need assistance to recharge their system. This system is MR conditional which is an additional benefit for patients who need to undergo MRI scans. I have been treating neuropathic pain patients with spinal cord stimulation since 1982. I believe this innovative system will be well accepted by Japanese patients.”

According to the Institute of Medicine, chronic pain affects more than 100 million Americans, an incidence rate which outpaces heart disease, cancer and diabetes combined. Past research has suggested that the condition can cost the American population an estimated 515 million workdays annually and generates upwards of 40 million visits to physicians each year. It is estimated that 17 million people are affected by chronic pain in Japan.

St. Jude Medical designed many elements of the Proclaim Elite MRI system based on physician and patient feedback to ensure patients could benefit from all aspects of the product. In particular, the non-rechargeable system improves patient convenience by removing the burden of regularly recharging the SCS system.

St. Jude Medical Japan Co., Ltd. also announced MHLW approval of the St. Jude Medical Invisible Trial System. The system, which received CE Mark in June 2015 and FDA approval in July 2015, is fully wireless and leverages Apple technology for both the patient and physician controllers. The system relies on Bluetooth wireless technology to provide patients a safe, secure and entirely wireless SCS trial experience. Patients will be able to evaluate spinal cord stimulation with the St. Jude Medical Invisible Trial System, with a discreet, app-based and wireless neuromodulation programming system leveraging Apple iPod touch mobile digital technology. It is also the first interfacing patient controller written in the Japanese language among currently-approved Neuromodulation devices in Japan.

For many patients, SCS therapy can be an effective option for managing chronic pain. The therapy relies on a small implanted device and thin wires (known as leads) to deliver low levels of electrical energy to mask or interrupt pain signals as they travel along nerve fibers to the brain, which reduces the sensation of pain. Prior to receiving a permanently implanted SCS device, patients undergo a minimally invasive “trial” period to evaluate the therapy. Yet for some patients, complex controllers and bulky programming cables can disrupt the trial experience and act as barrier to SCS therapy.

With the Invisible Trial System, St. Jude Medical has removed these barriers, allowing patients to more effectively evaluate their SCS therapy.

“SCS trialed patients are telling us about the inconvenience of having cables around their body and difficulties in operating the device, especially for elderly patients. It is important to reproduce conditions that are close to the patients’ daily life so that they can adequately assess the effectiveness of SCS therapy,” said Dr. Yoichiro Abe, Director of the Pain Clinic, NTT East NTT Medical Center Tokyo. “By introducing a wireless, invisible trial system, St. Jude Medical can help reduce the burden on the patients associated with conventional trial system. It is great news that the remote controller (patient controller) will be interfacing in Japanese. If instructions in Japanese can be displayed on the iPod touch screen which is bigger than conventional devices, patients can focus more on their therapy and functional improvements without struggling with the operation of the device. Furthermore, Apple mobile digital technology will enable clinicians to provide optimal therapy by monitoring the patients in a Bluetooth-enabled distance and adjust the stimulation parameters accordingly.”

One of the key system features of the St. Jude Medical Invisible Trial System is the use of a small external pulse generator (EPG) as the system’s power source. Because the EPG uses Bluetooth wireless technology to communicate between the patient’s iPod touch controller and the stimulation system, the overall device profile has been reduced so the system can be worn discreetly under a patient’s clothing. The effect is that the system feels essentially “invisible” to the wearer, providing a more comfortable trial experience that allows patients to focus entirely on their system’s therapeutic impact during their trial.

“When we developed the new Invisible Trial System, we took into account physician and patient feedback that current trial systems were in some cases preventing patients from adequately assessing their therapy,” said Mark Carlson, M.D., chief medical officer and vice president of global clinical affairs at St. Jude Medical. “By providing a more patient-friendly option, we think we can shorten the learning curve related to trial programming devices and allow patients to better assess the potential pain relief they’re receiving from spinal cord stimulation.”

The iPod touch controller offers patients a simple, familiar platform to adjust their therapy. An iPad mini tablet is used by the patient’s physician to set the programming parameters. The programmer also displays trial usage data from the EPG and allows the physician to print or email the data in PDF format. Bluetooth wireless technology safely and securely communicates wirelessly between the EPG and patient and physician devices, eliminating the programming trial cable and thus increasing the patient’s comfort.

With its latest round of SCS product offerings, St. Jude Medical aims to further enhance ease-of-use and familiarity for patients by leveraging Bluetooth wireless technology and Apple mobile digital devices for the Proclaim Elite MRI SCS system’s patient controller and clinician programmer. This approach will allow patients to interact with their device more easily, which can ensure effective management of their chronic pain treatment with minimal disruption to their daily life.

“St. Jude Medical has a legacy of consistently advancing spinal cord stimulation therapy options to ensure chronic pain patients are receiving innovative, patient-centric devices and optimal therapy to manage their chronic pain,” said Allen Burton, M.D., medical director of neuromodulation at St. Jude Medical. “The new St. Jude Medical Proclaim Elite MRI SCS system bridges the gap between today’s state-of-the-art therapies and tomorrow’s ground-breaking innovations for chronic pain. The wireless platform is based on the latest Apple technologies making it upgradeable to new therapies for the future. With a discreet, hassle-free trial system and a simple permanent implant procedure, this pioneering platform can improve both the patient’s chronic pain and overall therapy experience.”

About Chronic Pain
Chronic pain is defined as pain that lasts longer than the normal healing period for disorders or injuries. It typically lasts longer than three to six months. The causes and mechanisms of pain are diverse. Some cases are of unknown etiology and intractable. The longer the pain persists, the more likely patients will suffer from stress or social problems. For treatment, we should investigate the causes to decide the treatment strategies for individual patients.

About the St. Jude Medical Chronic Pain Portfolio
Chronic pain affects approximately 1.5 billion people worldwide, more than heart disease, cancer and diabetes combined. The condition can negatively impact personal relationships, work productivity and a patient’s daily routine. St. Jude Medical is an international leader in the development of innovative chronic pain therapeutic options and offers multiple solutions for patients to manage debilitating chronic pain, including spinal cord stimulation, spinal cord stimulation targeting the DRG and radiofrequency ablation.

About St. Jude Medical (this is the Japanese version with the global legal approval)
St. Jude Medical is a leading global medical device manufacturer and is dedicated to transforming the treatment of some of the world’s most expensive epidemic diseases. The company does this by developing cost-effective medical technologies that save and improve lives of patients around the world. Headquartered in St. Paul, Minn., St. Jude Medical has five major areas of focus that include heart failure, atrial fibrillation, neuromodulation, traditional cardiac rhythm management, and cardiovascular diseases.