Medtronic Launches New Activa™ Patient Programmer for DBS Therapy
来源: Nasdaq GlobeNewswire / 30 十月 2019 18:00:06 Europe/London
System Offers at Home Therapy Management for DBS patients
Using Patient-Friendly Consumer Technology
DUBLIN and SAN JOSE, Calif., Oct. 30, 2019 (GLOBE NEWSWIRE) -- Medtronic plc (NYSE:MDT) today announced the U.S. launch of its advanced Patient Programmer technology for Deep Brain Stimulation (DBS) therapy at the Samsung Developers Conference in San Jose, Calif. The new programmer – which received U.S. Food and Drug Administration (FDA) approval on July 3, 2019 – leverages a user-friendly, custom-configured Samsung mobile device which allows patients to manage their therapy more simply and discreetly. To date, more than 150,000 patients have been implanted with Medtronic DBS devices for management of Parkinson’s symptoms and other conditions.
“It is important for patients to have access to advanced technology for user-friendly therapy management at home,” says Sandeep Thakkar, D.O., neurologist and movement disorder specialist at Hoag’s Pickup Family Neurosciences Institute. “The new Medtronic DBS Activa™ Patient Programmer device is an innovative tool that combines familiar consumer technology with medical devices, which facilitates better control for patients in an easier, more accessible way.“
The Patient Programmer leverages Samsung Knox security technology to help protect the device and patient. The Patient Programmer consists of two components — a programmer handset and a communicator, designed to help patients get the most from their DBS therapy. The programmer utilizes a Samsung smartphone, with a customized, intuitive user interface, on a large 5-inch color touchscreen. The network-connected smartphone and system design lays the foundation for patient data to be shared directly with clinical staff. Clinicians can also define settings and coordinate directly with their patients to adjust DBS therapy settings between clinic visits.
The communicator is a separate device that synchronizes with the implanted device and provides a secure connection to the programmer handset. When patients want to adjust physician-prescribed therapy settings, turn therapy on or off, or check the neurostimulator’s battery, they simply hold the communicator over the implanted device and make desired changes using the programmer.
“Medtronic’s DBS therapy managed via Samsung devices offers users a blend of safety and control of their data, while also offering elegance and simplicity of use,” said Taher Behbehani, head of the Mobile B2B Division, Samsung Electronics America. “It’s through our open yet secure mobility platform that we can offer this level of customization on our market-leading devices, and why the world’s leading companies like Medtronic choose to work with us.”
“Medtronic has been the leader in DBS therapy for over 25 years. This launch continues to serve as further evidence of our dedication to our DBS patients allowing them to experience an altogether smarter therapeutic journey,” said Mike Daly, vice president and general manager of the Brain Modulation business, which is part of the Restorative Therapies Group at Medtronic. “The new Patient Programmer builds out an end-to-end solution between patient and healthcare provider with the DBS Clinician Programmer and Activa Programming Application. With this device, patients gain confidence, as they are able to discreetly manage their DBS therapy no matter where they are.”
Managed on Samsung Galaxy Tab S2 tablet interface, the Clinician Programmer and Activa Programming Application provides a familiar clinical programming experience, streamlined workflows and actionable information to support neurologists and neurosurgeons in their treatment of patients. Medtronic has partnered with Samsung since 2013 to enhance multiple therapies by integrating Samsung’s user friendly, secure mobile devices into the solution.
According to the Parkinson’s Foundation, nearly one million people will be living with Parkinson's disease in the U.S. by 2020 - while an estimated 10 million Americans have essential tremor (ET) according to the International Essential Tremor Foundation. ET is a neurological condition that causes shaking of the hands, head, and voice.
About Medtronic DBS Therapy
DBS therapy uses a surgically implanted medical device, similar to a cardiac pacemaker, to deliver electrical stimulation to precisely targeted areas of the brain as adjunctive treatment for several neurological disorders. Medtronic DBS systems are the first approved for full-body MRI scans under specific conditions in the United States. Since 1997, more than 150,000 Medtronic DBS devices have been implanted worldwide for movement disorders and other indications.
DBS therapy is currently approved in many locations around the world, including the United States and Europe, for the treatment of the disabling symptoms of epilepsy*, essential tremor and recent and longer-standing Parkinson's disease. Under Humanitarian Device Exemption (HDE) approvals** in the United States, the therapy can also be used to treat chronic intractable primary dystonia and severe, treatment-resistant obsessive-compulsive disorder.
*The new Activa™ Patient Programmer is not approved for epilepsy.
** Humanitarian Device: The effectiveness of the devices for the treatment of dystonia and obsessive-compulsive disorder has not been demonstrated.
Medtronic plc (www.medtronic.com), headquartered in Dublin, Ireland, is among the world’s largest medical technology, services and solutions companies – alleviating pain, restoring health and extending life for millions of people around the world. Medtronic employs more than 90,000 people worldwide, serving physicians, hospitals and patients in more than 150 countries. The company is focused on collaborating with stakeholders around the world to take healthcare Further, Together.
Any forward-looking statements are subject to risks and uncertainties such as those described in Medtronic's periodic reports on file with the Securities and Exchange Commission. Actual results may differ materially from anticipated results.
Samsung Knox and Samsung Galaxy Tab S2 are trademarks of SAMSUNG ELECTRONICS CO., LTD.
David T. Young