Medtronic receives FDA approval for Inceptiv closed-loop spinal cord stimulator

Closed-loop sensing capability instantly and automatically adjusts therapy while treating chronic pain

Medtronic plc (NYSE:MDT), a global leader in healthcare technology, today announced that the U.S. Food and Drug Administration (FDA) has approved the Inceptiv™ closed-loop rechargeable spinal cord stimulator (SCS) for the treatment of chronic pain. Inceptiv is the first Medtronic SCS device to offer a closed-loop feature that senses biological signals along the spinal cord and automatically adjusts stimulation in real time, keeping therapy in harmony with the motions of daily life.

"Pain is intensely personal, and stimulation therapy should meet the needs of every patient, moment to moment," said Dr. Krishnan Chakravarthy , M.D., Ph.D., Director of Innovative Pain Treatment Solutions and Surgery Center, VA San Diego Healthcare, and Chairman of the Empower You Chronic Pain Foundation. "Inceptiv listens to what the body is saying and, more quickly than you can blink, it seamlessly adjusts. This represents an important leap forward for the treatment of chronic pain."

Traditional fixed-output SCS devices deliver constant, mild electrical impulses that disrupt pain signals before they reach the brain. As patients go about their daily lives, certain movements such as laughing, bending, or sneezing may result in brief moments of uncomfortable overstimulation. This in turn may lead some patients to turn down their device's stimulation output, resulting in a suboptimal therapy experience.

By contrast, Inceptiv SCS senses biological signals and consistently maintains the physician's prescribed stimulation that is tailored to a patient's needs. Specialized circuitry and a proprietary algorithm detect ECAPs (Evoked Compound Action Potentials), signals generated by the spinal cord in response to electrical stimuli. ECAPs are a direct measure of how much nerve tissue is activated in the spinal cord and can be used to inform real-time adjustments to stimulation. Inceptiv SCS senses the body's response to stimulation 50 times per second and instantly increases or decreases stimulation to maintain prescribed settings as determined by the physician.

The Inceptiv system delivers additional advantages beyond its closed-loop capability. Inceptiv offers unparalleled access to diagnostic imaging, with 1.5T and 3T full-body MRI access with no power or impedance restrictions. It is the only FDA-approved closed-loop spinal cord stimulator that offers full-body 3T MRI access. Up to 84% of SCS-implanted patients are expected to need at least one MRI within five years of implant. 1 It is the world's smallest and thinnest fully implantable SCS device, designed for patient comfort. In addition, Inceptiv SCS allows the option of multiple types of waveforms, including Medtronic's proprietary DTM™ SCS therapy, which demonstrated an 84% responder rate at 12 months in a large, multicenter randomized controlled trial (RCT). 2,3 Patients with Inceptiv SCS can also access CareGuidePro™, a mobile application and web portal that serves as a virtual guide throughout their Medtronic spinal cord stimulation therapy journey.

"A new era for spinal cord stimulation technology is beginning, and with Inceptiv SCS, Medtronic is at the forefront," said David Carr , vice president and general manager, Pain Interventions within the Neuromodulation business, which is part of the Neuroscience Portfolio at Medtronic. "For patients dealing with chronic pain, every day is a struggle. They deserve personalized and effective relief, without compromising future access to MRI. They deserve the comfort that the smallest and thinnest device on the market can provide. We are proud to offer the most cutting-edge solution available today with Inceptiv SCS."

Medtronic will initiate the U.S. market launch of Inceptiv in the coming weeks. The system previously earned approvals for sale in Europe and in Japan . For more information, visit Medtronic.com/Inceptiv .

† Sensing signals may not be measurable in all cases

‡ Under certain conditions. Refer to product labeling for full list of conditions.

About Medtronic
Bold thinking. Bolder actions. We are Medtronic. Medtronic plc, headquartered in Dublin, Ireland , is the leading global healthcare technology company that boldly attacks the most challenging health problems facing humanity by searching out and finding solutions. Our Mission — to alleviate pain, restore health, and extend life — unites a global team of 95,000+ passionate people across 150 countries. Our technologies and therapies treat 70 health conditions and include cardiac devices, surgical robotics, insulin pumps, surgical tools, patient monitoring systems, and more. Powered by our diverse knowledge, insatiable curiosity, and desire to help all those who need it, we deliver innovative technologies that transform the lives of two people every second, every hour, every day. Expect more from us as we empower insight-driven care, experiences that put people first, and better outcomes for our world. In everything we do, we are engineering the extraordinary. For more information on Medtronic (NYSE:MDT), visit www.Medtronic.com , and follow Medtronic on LinkedIn .

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.

_____________________

1 Desai, Mehul J., et al. "The rate of magnetic resonance imaging in patients with spinal cord stimulation." Spine, vol. 40, no. 9, 2015, https://doi.org/10.1097/brs.0000000000000805.

2 Fishman, M, Cordner, H, Justiz, R, Provenzano, D, Merrell, C, Shah, B, et al. Twelve-Month results from multicenter, open-label, randomized controlled clinical trial comparing differential target multiplexed spinal cord stimulation and traditional spinal cord stimulation in subjects with chronic intractable back pain and leg pain. Pain Pract. 2021; 21: 912– 923

3 DTM™ SCS outcomes demonstrated using open-loop SCS

Contacts:


Jeff Trauring

Ryan Weispfenning

Public Relations

Investor Relations

+1-763-505-0159

+1-763-505-4626

(PRNewsfoto/Medtronic plc)

Cision View original content to download multimedia: https://www.prnewswire.com/news-releases/medtronic-receives-fda-approval-for-inceptiv-closed-loop-spinal-cord-stimulator-302128632.html

SOURCE Medtronic plc

Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/April2024/26/c2293.html

News Provided by Canada Newswire via QuoteMedia

MDT
The Conversation (0)

Canadian Natural Resources Limited Announces 2024 First Quarter Results

Canadian Natural's (TSX: CNQ) (NYSE: CNQ) President, Scott Stauth, commented on the Company's first quarter results, "Canadian Natural is a world class company and during our 35 years of operations, we've delivered significant value, including recently reaching a position where, commencing in 2024, we are returning 100% of our free cash flow to our shareholders. Crude oil price forecasts have strengthened for the remainder of 2024, including improvements in West Texas Intermediate ("WTI"), Western Canadian Select ("WCS") and Synthetic Crude Oil ("SCO") pricing over those prices experienced in the first quarter of 2024, driving significant targeted free cash flow generation going forward.

News Provided by Newsfile via QuoteMedia

Keep reading...Show less

PrairieSky Announces First Quarter 2024 Results, Record Oil Royalty Production

-

PrairieSky Royalty Ltd. ("PrairieSky" or the "Company") (TSX: PSK) is pleased to announce its first quarter ("Q1 2024") operating and financial results for the three-month period ended March 31, 2024.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

PrairieSky Announces Fourth Quarter And Year-End Results For 2023, Including Record Oil Royalty Production, Strong Leasing Activity And Increased Annual Dividend

PrairieSky Royalty Ltd. (" PrairieSky " or the " Company ") (TSX: PSK) is pleased to announce its fourth quarter (" Q4 2023 ") and year-end operating and financial results for the period ended December 31, 2023. PrairieSky is also pleased to announce a 4% increase in its annual dividend to $1.00 per common share ($0.25 per common share quarterly).

Fourth Quarter Highlights

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

PrairieSky Announces 2023 Third Quarter Results

PrairieSky Royalty Ltd. (" PrairieSky " or the " Company ") (TSX: PSK) is pleased to announce its third quarter (" Q3 2023 ") results for the three-month period ended September 30, 2023.

Third Quarter Highlights

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Notice of Knight Therapeutics' First Quarter 2024 Results Conference Call

Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a leading pan-American (ex-USA) specialty pharmaceutical company, will release its first quarter 2024 financial results on Thursday, May 9, 2024 prior to market opening. Following the release, Knight will hold a conference call and audio webcast. Knight cordially invites all interested parties to participate in this call.

Date : Thursday, May 9, 2024

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Bausch Health Announces First Quarter 2024 Results

  • First quarter revenues of $2.15 billion, up 11% on a Reported and 8% on an Organic1 basis
  • Year-over-year revenue growth in all segments on both a Reported and Organic1 Basis
  • GAAP Net Loss Attributable to Bausch Health Companies Inc. of $64 Million
  • Adjusted EBITDA Attributable to Bausch Health Companies Inc. (non-GAAP)1 of $665 Million, up 13%
  • Xifaxan® Appeal Decision Represents a Significant Milestone related to Full Separation of Bausch + Lomb
  • Reaffirmed full-year Revenue and Adjusted EBITDA (non-GAAP)1 guidance

Bausch Health Companies Inc. (NYSE:BHC)(TSX:BHC) ("Bausch Health" or the "Company" or "we" or "our") today announced its first quarter 2024 financial results and other key updates from the quarter

"We are pleased with our strong start to the year, delivering solid first-quarter performance, and our fourth consecutive quarter of year-over-year growth in revenues and adjusted EBITDA. Furthermore, all our business segments posted year-over-year revenue growth on both a reported and organic basis. I'm very proud of what our team has accomplished and we remain focused on continuing our momentum by advancing our R&D pipeline, strengthening our balance sheet and executing on our commercial strategies to drive global growth," said Thomas J. Appio, Chief Executive Officer, Bausch Health.

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less
Scientists working in a modern medical research laboratory.

Pathways to Commercializing Biotech Innovations

In the medical technology industry, innovation is only the first step. While key to long-term success, innovation is only as good as a company’s commercialization strategy. Once a technology has been developed and proven, the organization must then embark on a process to commercialize it for revenue generation.

The strategy a company leverages to pursue commercialization is a crucial ingredient in building a successful and profitable venture.

Investors would do well to understand the distinctive process and strategies required to bring medtech solutions to market to help them make more informed investment decisions.

Keep reading...Show less

Medtronic: 'Pivotal Moment' in Women's Heart Health

Female-specific results from first-of-its-kind clinical trial

Teaching first graders takes a lot of energy. So when Julia Garcia started feeling worn out, teaching became extremely difficult

News Provided by ACCESSWIRE via QuoteMedia

Keep reading...Show less
Cleo Diagnostics

March 2024 Quarterly Activities Report

Ovarian cancer diagnostics company, Cleo Diagnostics Limited (ASX:COV) (CLEO, or the Company) is pleased to provide the market with an update on activities in the March 2024 quarter as it develops its simple and accurate blood test for the early detection of ovarian cancer.

Keep reading...Show less
Illustration of heart attack.

Investing in Cardiovascular MedTech Companies

Cardiovascular diseases remain the leading global cause of death, taking an estimated 17.9 million lives annually, based on data from the World Health Organisation. Over 80 percent of these deaths are due to heart attacks and strokes, while one-third of them occur in people under seventy years of age.

Efforts to address the core risk factors associated with cardiovascular diseases are coinciding with recent innovations in medical technology, which have been critical in not only preventing and managing them but also increasing the survival rate.

As medical technologies associated with the diagnosis and treatment of cardiovascular disease continue to evolve, medical technology companies provide an opportunity for investors to create wealth through health.

Keep reading...Show less

Latest Press Releases

Related News

×