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

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星期五, 四月 26, 2024

Sale, FDA, Brain, Patient, SCS, Spinal cord stimulator, Neuromodulation, Food, Neuroscience, Medtronic, Spinal cord, Sneeze, Google Images, MRI, RCT, Connective tissue, ECAPS, Chronic pain, Medical imaging

DUBLIN, April 26, 2024 /PRNewswire/ -- 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.

Key Points:

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.
Traditional fixed-output SCS devices deliver constant, mild electrical impulses that disrupt pain signals before they reach the brain.
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.

Saluda Medical Announces Late Breaking Data at NANS 2024 Annual Meeting

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星期二, 一月 16, 2024

Patient, Chronic pain, NANS, RCT, Spinal cord stimulator, ECAPS, Nerve, SCS, Annual general meeting, MAE

MINNEAPOLIS, Jan. 16, 2024 /PRNewswire/ -- Saluda Medical, Inc., a global medical device company revolutionizing the field of neuromodulation with an emerging portfolio of therapies driven by advanced closed-loop technologies, today announced the company's data will be presented at the North American Neuromodulation Society (NANS) 2024 Annual Meeting, taking place January 18-21.

Key Points:

MINNEAPOLIS, Jan. 16, 2024 /PRNewswire/ -- Saluda Medical, Inc., a global medical device company revolutionizing the field of neuromodulation with an emerging portfolio of therapies driven by advanced closed-loop technologies, today announced the company's data will be presented at the North American Neuromodulation Society (NANS) 2024 Annual Meeting, taking place January 18-21.
The 3-Year EVOKE Study demonstrated superior pain relief in the closed-loop (SmartLoop™) arm versus the open-loop arm.
The evidence presented at NANS demonstrates SmartLoop's capability to provide long-term superior outcomes for patients as well as advance SCS therapy efficiencies for clinical practices," said Jim Schuermann, President and CEO of Saluda Medical.
For more information, please visit us at NANS: Saluda Medical Booth #339.

EQS-News: Notice to the Holders of the Preferred Securities

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星期一, 九月 25, 2023

ALL, London Stock Exchange, Financial Conduct Authority, TIMELY, ECAPS, OF, RSM, London, United Kingdom, PDF, RNS, News, Security (finance)

NOTICE TO THE HOLDERS OF:

Key Points:

NOTICE TO THE HOLDERS OF:
THIS NOTICE CONTAINS IMPORTANT INFORMATION THAT IS OF INTEREST TO THE REGISTERED AND BENEFICIAL OWNERS OF THE SUBJECT SECURITIES.
IF APPLICABLE, ALL DEPOSITORIES, CUSTODIANS AND OTHER INTERMEDIARIES RECEIVING THIS NOTICE ARE REQUESTED TO EXPEDITE THE RE-TRANSMITTAL TO BENEFICIAL OWNERS OF THE SECURITIES IN A TIMELY MANNER.
Your attention is drawn to the formal notice contained in the PDF link below concerning the Company, LP V and the LP V ECAPS.
In order to view the formal notice, it is recommended that you copy and paste the link into your browser.

Lehman Brothers UK Capital Funding V LP: Notice to the Holders of the Preferred Securities

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星期四, 九月 21, 2023

ALL, London Stock Exchange, Financial Conduct Authority, TIMELY, ECAPS, OF, RSM, London, United Kingdom, PDF, RNS, Security (finance)

NOTICE TO THE HOLDERS OF:

Key Points:

NOTICE TO THE HOLDERS OF:
THIS NOTICE CONTAINS IMPORTANT INFORMATION THAT IS OF INTEREST TO THE REGISTERED AND BENEFICIAL OWNERS OF THE SUBJECT SECURITIES.
IF APPLICABLE, ALL DEPOSITORIES, CUSTODIANS AND OTHER INTERMEDIARIES RECEIVING THIS NOTICE ARE REQUESTED TO EXPEDITE THE RE-TRANSMITTAL TO BENEFICIAL OWNERS OF THE SECURITIES IN A TIMELY MANNER.
Your attention is drawn to the formal notice contained in the PDF link below concerning the Company, LP V and the LP V ECAPS.
In order to view the formal notice, it is recommended that you copy and paste the link into your browser.

Medtronic receives CE Mark approval for Inceptiv™ spinal cord stimulator with closed-loop sensing to treat chronic pain

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星期五, 八月 25, 2023

Sneeze, Spinal cord stimulator, Schleswig-Holstein, Medtronic, Spinal cord, Neuroscience, Brain, Movement, Sale, Teaching hospital, Trial of the century, MRI, Patient, ECAPS, Pain management, NYSE, SCS, Medical imaging, Neuromodulation

DUBLIN, Aug. 25, 2023 /PRNewswire/ -- Medtronic plc (NYSE:MDT), a global leader in healthcare technology, has received CE (Conformité Européenne) Mark approval for its Inceptiv™ closed-loop rechargeable spinal cord stimulator (SCS). It is the first Medtronic SCS device to offer a closed-loop feature that senses each person's unique biological signals and adjusts stimulation moment to moment, as needed, to keep therapy in harmony with the motions of daily life. †

Key Points:

DUBLIN, Aug. 25, 2023 /PRNewswire/ -- Medtronic plc (NYSE:MDT), a global leader in healthcare technology, has received CE (Conformité Européenne) Mark approval for its Inceptiv™ closed-loop rechargeable spinal cord stimulator (SCS).
†
Spinal cord stimulators deliver mild electrical impulses to the spinal cord, which can disrupt pain signals before they reach the brain.
This in turn may lead some patients to turn down their device's stimulation output, resulting in a suboptimal therapy experience.
"This approval marks the beginning of a new era of pain relief, using sensing technology to listen to the unique biological signals of each patient."

APhA applauds introduction of Senate legislation to ensure senior access to prompt pharmacist care and services

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星期三, 七月 26, 2023

S. 2477 would establish Medicare Part B direct reimbursement for essential pharmacist services for COVID-19, influenza, respiratory syncytial virus (RSV), and strep throat.

Key Points:

S. 2477 would establish Medicare Part B direct reimbursement for essential pharmacist services for COVID-19, influenza, respiratory syncytial virus (RSV), and strep throat.
1770, recognizing the urgent need to ensure seniors in rural and underserved communities across the country maintain access to pharmacist care.
"This bill is an important step towards ensuring seniors, especially those in rural areas, maintain access to essential pharmacist services.
In many rural communities, pharmacists are the only accessible health care provider and play a critical role in delivering patient services.

CMS Grants Transitional Pass-Through (TPT) Payment for Saluda's Evoke® SCS System

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星期一, 十一月 7, 2022

ARTARMON, Australia, Nov. 7, 2022 /PRNewswire/ -- Saluda Medical Pty Limited ("Saluda Medical"), a global medical device company revolutionizing the field of neuromodulation, announced the Centers for Medicare & Medicaid Services (CMS) has granted approval for a transitional pass-through (TPT) payment for the Evoke® SmartSCS™ System, under the Medicare hospital outpatient prospective payment system. "The Evoke® SCS System represents a substantial clinical improvement over existing technologies based on the data received from commenters", according to CY2023 OPPS/ASC Final Rule. The Department of Health and Human Services (HHS)-approved document also states, "We believe this RCT (EVOKE Study) comparison served to demonstrate substantial clinical improvement provided by the closed-loop system, differentiating it from open-loop systems typically described by existing device categories, thus supporting the creation of a new device category". The TPT payment, which will be effective for three years beginning January 1, 2023, is a mechanism created by CMS to increase patient access to new and innovative technology while allowing hospitals and Ambulatory Surgery Centers (ASCs) to receive additional payment for the use of new technology.

Key Points:

"The Evoke SCS System represents a substantial clinical improvement over existing technologies based on the data received from commenters", according to CY2023 OPPS/ASC Final Rule.
The TPT payment for the Evoke System will provide incremental Medicare reimbursement to providers beyond the established payment for the implantation of spinal cord stimulation devices.
CMS determined that the Evoke System met the TPT criteria based on the published EVOKE Study, the only double-blinded randomized control trial (RCT) in the spinal cord stimulation space.
The Evoke System received FDA approval earlier this year based on the landmark EVOKE Study which showed closed loop superiority over open-loop SCS in treating overall back and leg pain.

Saluda Medical Surpasses Milestone: Measuring One Trillionth ECAP From Patients with the Evoke® System

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星期二, 十月 25, 2022

ARTARMON, Australia, Oct. 25, 2022 /PRNewswire/ -- Saluda Medical Pty Limited ("Saluda Medical"), a global medical device company revolutionizing the field of neuromodulation, today announced it has recorded and measured over one trillion Evoked Compound Action Potentials (ECAPs) with the Evoke® Spinal Cord Stimulation (SCS) System, representing a milestone in the company's mission to use big data to deliver transformational therapies to the global SCS market. Saluda's Evoke® System is the only approved therapy capable of automatically adjusting real time to the neurophysiologic changes each patient undergoes throughout the day. The Evoke® System, powered by the groundbreaking SmartLoop™ technology, has demonstrated long-term, sustained pain relief as well as improvements in patients' quality of life, functional status, mood, and sleep in the only double-blinded randomized controlled study in the SCS space with 24-month follow up data.

Key Points:

Saluda's Evoke System is the only approved therapy capable of automatically adjusting real time to the neurophysiologic changes each patient undergoes throughout the day.
Data and insights captured to date stand to accelerate the fundamental understanding of chronic pain and further enhance EvokeSCS System performance.
Saluda Medical is a global company transforming patients' lives with disruptive neural sensing technologies designed to revolutionize the field of neuromodulation.
Saluda Medical and Evoke are registered trademarks owned by Saluda Medical Pty Ltd.
View original content to download multimedia: https://www.prnewswire.com/news-releases/saluda-medical-surpasses-milest...

DGAP-News: Lehman Brothers UK Cap Fdg V LP: Notice to the Holders of the Preferred Securities

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星期二, 八月 30, 2022

Lehman Brothers UK Cap Fdg V LP: Notice to the Holders of the Preferred Securities

Key Points:

Lehman Brothers UK Cap Fdg V LP: Notice to the Holders of the Preferred Securities
The issuer is solely responsible for the content of this announcement.
NOTICE TO THE HOLDERS OF:
THIS NOTICE CONTAINS IMPORTANT INFORMATION THAT IS OF INTEREST TO THE REGISTERED AND BENEFICIAL OWNERS OF THE SUBJECT SECURITIES.
IF APPLICABLE, ALL DEPOSITORIES, CUSTODIANS AND OTHER INTERMEDIARIES RECEIVING THIS NOTICE ARE REQUESTED TO EXPEDITE THE RE-TRANSMITTAL TO BENEFICIAL OWNERS OF THE SECURITIES IN A TIMELY MANNER.
Your attention is drawn to the formal notice contained in the PDF link below concerning the Company, LP V and the LP V ECAPS.

Lehman Brothers UK Capital Funding V LP: Notice to the Holders of the Preferred Securities

Retrieved on:

星期二, 八月 30, 2022

London, Financial Conduct Authority, OF, London Stock Exchange, ECAPS, TIMELY, RSM, ALL, PDF, RNS, Company, THE, United Kingdom, Security (finance)

NOTICE TO THE HOLDERS OF:

Key Points:

NOTICE TO THE HOLDERS OF:
THIS NOTICE CONTAINS IMPORTANT INFORMATION THAT IS OF INTEREST TO THE REGISTERED AND BENEFICIAL OWNERS OF THE SUBJECT SECURITIES.
IF APPLICABLE, ALL DEPOSITORIES, CUSTODIANS AND OTHER INTERMEDIARIES RECEIVING THIS NOTICE ARE REQUESTED TO EXPEDITE THE RE-TRANSMITTAL TO BENEFICIAL OWNERS OF THE SECURITIES IN A TIMELY MANNER.
Your attention is drawn to the formal notice contained in the PDF link below concerning the Company, LP V and the LP V ECAPS.
In order to view the formal notice, it is recommended that you copy and paste the link into your browser.