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)
Pine Cliff Energy Ltd. Announces First Quarter 2024 Results and Information Regarding the Annual Meeting of Shareholders

Pine Cliff Energy Ltd. Announces First Quarter 2024 Results and Information Regarding the Annual Meeting of Shareholders

Pine Cliff Energy Ltd. (TSX: PNE) ("Pine Cliff" or the "Company") announces its first quarter 2024 financial and operating results, an operational update and information regarding the annual meeting of shareholders.

First Quarter 2024 Results

News Provided by Newsfile via QuoteMedia

Keep reading...Show less

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
Pine Cliff Energy Ltd. Announces Appointment of Officers, Declares Monthly Dividend for May 31, 2024 and First Quarter 2024 Webcast Details

Pine Cliff Energy Ltd. Announces Appointment of Officers, Declares Monthly Dividend for May 31, 2024 and First Quarter 2024 Webcast Details

Pine Cliff Energy Ltd. (TSX: PNE) (OTCQX: PIFYF) ("Pine Cliff" or the "Company") is pleased to announce the appointments of Mr. Daniel Keenan P. Eng to the position of Vice President Exploitation and Mr. Austin Nieuwdorp CA, CPA to the position of Vice President Finance and Controller both effective May 1, 2024.

Mr. Keenan became part of Pine Cliff in 2016. He holds a Bachelor of Mechanical Engineering Degree from the University of Victoria obtained in 2001. Throughout his 20-year career, he has taken on increasingly challenging roles in exploitation, production operations and facilities engineering, culminating in his most recent position as Pine Cliff's Manager of Exploitation. Notably, Mr. Keenan has played a pivotal role in identifying and expanding Pine Cliff's asset portfolio and drilling opportunities, showcasing his leadership and strategic vision.

News Provided by Newsfile via QuoteMedia

Keep reading...Show less
ATCO Ltd. to Share Strategic Update at Annual General Meeting on May 15, 2024

ATCO Ltd. to Share Strategic Update at Annual General Meeting on May 15, 2024

ATCO Ltd. (TSX: ACO.X) (TSX: ACO.Y)

2024 ATCO AGM (CNW Group/ATCO Ltd.)

ATCO Ltd. (ATCO) will hold its 57th Annual General Meeting of share owners at 10 a.m. MDT on Wednesday , May 15, 2024. In addition to the formal business of the meeting, attendees will hear management's view of ATCO's full year 2023 and first quarter 2024 operational and financial performance.

At this year's meeting, members of the ATCO executive leadership team will also outline growth strategies and goals for ATCO Structures, ATCO EnPower and ATCO Energy Systems.

Attendees will hear from:

  • Nancy Southern , Chair & Chief Executive Officer
  • Katie Patrick , Executive Vice President, Chief Financial & Investment Officer
  • Adam Beattie , President, ATCO Structures
  • Bob Myles , Chief Operating Officer, ATCO EnPower
  • Wayne Stensby , Chief Operating Officer, ATCO Energy Systems

Share owners and interested parties can view the meeting virtually using Microsoft Teams via this link using a web browser (Chrome, Safari, Edge or Firefox) on a smartphone, tablet or computer. Using Internet Explorer is not recommended as it is no longer supported and may not function properly.

Attendees who are share owners or proxyholders wishing to vote their shares should review the information contained in the ATCO Management Proxy Circular dated March 11, 2024 , beginning on page one.

As a global enterprise ATCO Ltd. and its subsidiary and affiliate companies have approximately 20,000 employees and assets of $25 billion . ATCO is committed to future prosperity by working to meet the world's essential energy, housing, security and transportation challenges. ATCO Structures designs, builds and delivers products to service the essential need for housing and shelter around the globe. ATCO Frontec provides operational support services to government, defence and commercial clients. ATCO Energy Systems delivers essential energy for an evolving world through its electricity and natural gas transmission and distribution, and international operations. ATCO EnPower creates sustainable energy solutions in the areas of renewables, energy storage, industrial water and clean fuels. ATCO Australia develops, builds, owns and operates energy and infrastructure assets. ATCOenergy and Rümi provide retail electricity and natural gas services, home maintenance services and professional home advice that bring exceptional comfort, peace of mind and freedom to homeowners and customers. ATCO also has investments in ports and transportation logistics, the processing and marketing of fly ash, retail food services and commercial real estate. More information can be found at www.ATCO.com .

Investor & Analyst Inquiries:  
Colin Jackson
Senior Vice President, Finance, Treasury & Sustainability
Colin.Jackson@atco.com
(403) 808 2636

Media Inquiries:
Kurt Kadatz
Director, Corporate Communications
Kurt.Kadatz@atco.com
(587) 228 4571

SOURCE ATCO Ltd.

Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/April2024/29/c6613.html

News Provided by Canada Newswire 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
Global AI Diagnostics Market to Reach $8.54 Billion By 2033 as Industry Sees Increasing R&D and Strategic Collaborations

Global AI Diagnostics Market to Reach $8.54 Billion By 2033 as Industry Sees Increasing R&D and Strategic Collaborations

FN Media Group News Commentary - Artificial intelligence (AI) is being utilized for disease detection in the global markets. In today's AI-driven world, the use of deep learning algorithms and AI tools in diagnostics can improve the accuracy, speed and efficiency for diagnosing patients with minimal errors. The introduction of AI tools in diagnostics has revolutionized the healthcare industry with supporting the doctors in advanced disease diagnosis and providing personalized treatments to patients with better judgements and quick results. According to Precedence Research, the global artificial intelligence in diagnostics market size was exhibited at USD 1.61 billion in 2024 and is projected to hit around USD 8.54 billion by 2033, growing at a CAGR of 20.37% during the forecast period 2024 to 2033. The report said: "The advances in digital biomarkers technology which uses real-time monitoring systems for early disease diagnosis and prediction has also enhanced the AI in diagnostics market growth. The application of AI tools in diagnostics has led to analyzing medical images for assessing disease progression, predicting patient outcomes, processing and storing of patient data which includes electronic health records (EHRs), identifying patterns and anomalies in patient data and symptom checkers for providing potential diagnosis."   Active healthcaretech companies active in the markets include: Avant Technologies Inc. (OTCQB: AVAI), Illumina Inc. (NASDAQ: ILMN), Tempus AI, Inc. (NASDAQ: TEM), Medtronic plc (NYSE: MDT), Spectral AI, Inc. (NASDAQ: MDAI).

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less
Medtronic Evolut TAVR system shows durable clinical outcomes and outstanding valve performance at five years in low-risk aortic stenosis patients

Medtronic Evolut TAVR system shows durable clinical outcomes and outstanding valve performance at five years in low-risk aortic stenosis patients

Medtronic plc (NYSE: MDT), a global leader in healthcare technology, today announced late-breaking data on five-year outcomes from the Evolut Low Risk Trial. Data shows, versus surgery, the Evolut™ transcatheter aortic valve replacement (TAVR) system delivers a numerically lower rate of all-cause mortality or disabling stroke at five years, strong valve performance and durable clinical outcomes. The findings were presented as late-breaking clinical science at the American College of Cardiology's Annual Scientific Session & Expo and simultaneously published in the JACC, the flagship journal of the American College of Cardiology .

The Evolut Low Risk Trial was a randomized, multicenter, international study assessing the safety and efficacy of the Evolut TAVR system versus surgery in low-risk patients. These patients had a predicted 30-day mortality risk

News Provided by PR Newswire via QuoteMedia

Keep reading...Show less
illustration of brain and cell phone.

BlinkLab Completes First Patient Test for US Autism Diagnostic Study

Digital healthcare company BlinkLab (ASX:BB1) has tested the first patient in its US autism diagnostic study, which is geared at validating the company's Dx1 test as a diagnostic aid for clinicians.

BlinkLab states in its Wednesday (March 12) release that the study is the largest digital diagnostic trial for autism in the US, with its aim being to support the early detection of developmental conditions like autism.

The first patient test took place at PriMED Clinical Research in Dayton, Ohio. PriMED, a division of PriMED Physicians, is one of two clinical sites selected for the study’s initial phase, which is targeting 100 patients.

Keep reading...Show less
Artificial Intelligence Influence on Healthcare Industry Reaching All Time Highs for Diagnostics and Treatments

Artificial Intelligence Influence on Healthcare Industry Reaching All Time Highs for Diagnostics and Treatments

FN Media Group News Commentary - A report from Fortune Business Insights said that the global artificial intelligence in healthcare market size is projected to grow from USD 27.69 billion in 2024 to USD 490.96 billion by 2032, exhibiting a CAGR of 43.2% during the forecast period. The report added: "AI in healthcare market in the U.S. is experiencing rapid expansion, driven by the increasing adoption of AI-powered solutions for diagnostics, personalized treatment, and administrative automation. North America dominated the AI in the healthcare market with a market share of 44.93% in 2023. Artificial Intelligence in healthcare is used to analyze the medical data that helps doctors and medical providers deliver accurate diagnoses and treatments to their patients. AI in healthcare assists doctors, nurses, and other healthcare workers to enhance their productivity. This advancement helps patients in treatment and improves their quality of life. Also, according to an article published by GE Healthcare, it is found that healthcare professionals are already using AI to improve data analysis, which has enabled them to diagnose their patients in a better way with proper predictions for the treatment and decrease the time spent by the medical staff on administrative functioning." Active companies active in the healthcare markets include: Avant Technologies Inc. (OTCQB: AVAI), Tempus AI, Inc. (NASDAQ: TEM), Teladoc Health (NYSE: TDOC), Aclarion, Inc. (NASDAQ: ACON), Medtronic plc (NYSE:MDT).

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Trian Comments on Solventum's Sale of its Purification & Filtration Business

Trian Fund Management, L.P. ("Trian"), which beneficially owns ~5% of Solventum Corporation (NYSE: SOLV) ("Solventum" or the "Company") and is the Company's largest active shareholder, commented on Solventum's recently announced sale of its Purification & Filtration business to Thermo Fisher Scientific Inc (NYSE: TMO) ("Thermo Fisher"). Trian issued the following statement:

"Trian commends Solventum on the announced sale of its Purification & Filtration business and believes this is an important first step in the Company's value creation journey. We believe that part of what attracted strategic interest at such a high valuation multiple was the division's differentiated technology and material science – attributes inherited from 3M which are present at Solventum's remaining businesses, and which we believe remain underappreciated by the market today.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Trian Comments on Solventum's Sale of its Purification & Filtration Business

Trian Fund Management, L.P. ("Trian"), which beneficially owns ~5% of Solventum Corporation (NYSE: SOLV) ("Solventum" or the "Company") and is the Company's largest active shareholder, commented on Solventum's recently announced sale of its Purification & Filtration business to Thermo Fisher Scientific Inc (NYSE: TMO) ("Thermo Fisher"). Trian issued the following statement:

"Trian commends Solventum on the announced sale of its Purification & Filtration business and believes this is an important first step in the Company's value creation journey. We believe that part of what attracted strategic interest at such a high valuation multiple was the division's differentiated technology and material science – attributes inherited from 3M which are present at Solventum's remaining businesses, and which we believe remain underappreciated by the market today.

News Provided by GlobeNewswire via QuoteMedia

Keep reading...Show less

Latest Press Releases

Related News

×