Insightec MR-Guided Focused Ultrasound Technology Recommended for National Coverage for Dutch Patients Living with Essential Tremor

The Netherlands is the latest European country to recommend national coverage for the treatment of essential tremor with focused ultrasound.

Insightec, a pioneer and global leader in focused ultrasound, has welcomed a positive recommendation report[1] from the Dutch Healthcare Institute (Zorginstituut Nederland, ZIN) to have MR-guided focused ultrasound (MRgFUS) reimbursed for people suffering from essential tremor (ET). This recommendation is a pivotal moment, paving the way for nation-wide access to focused ultrasound treatment for essential tremor.

ZIN Recommendation

Released to the public on the public on December 18, 2023, the ZIN recommendation concludes that MRgFUS (also called high-intensity focused ultrasound, or HIFU) which was pioneered by Insightec, is an effective treatment for patients with moderate to severe medication-refractory essential tremor who are not suitable for deep brain stimulation. It also concludes that these patients should therefore be included in the national basic health insurance package, which would guarantee patient access to the therapy. The report was produced following a request submitted by Amsterdam UMC in early 2023 with the support of Dutch medical societies, including the Dutch Association for Neurosurgery (NVvN) and the Dutch Association for Neurology (NVN).

“This is an important day not only for us at Insightec, but also for over 17 million Dutch residents who could not have access to focused ultrasound treatment for essential tremor so far,” says Maurice Ferré, M.D., CEO and chairman of the board of Insightec. “We are delighted to welcome the Netherlands in the growing club of countries that secure patient access to MRgFUS.”

Significant Reductions in Upper Limb Tremor

According to an Insightec study, patients experienced significant reductions in upper limb tremor, tremor-related disability, and quality of life. The most common intraprocedural adverse events included dizziness, headache, nausea, and vomiting, which all resolved. Post-procedural adverse events included paraesthesia and gait disturbance, which were often transient or resolved within 12 months.[2]

About MRgFUS. MR-guided focused ultrasound (MRgFUS), an effective, non-invasive treatment option for essential tremor. MRgFUS uses specialised ultrasound technology to deliver targeted brain therapy without an incision to ablate the brain tissue that causes abnormal movements. Guided by MRI to target the specific area of the brain, neurosurgeons benefit from real-time, detailed images of the brain for precise localisation and monitoring during the procedure.

About Essential Tremor. Essential tremor (ET) is the most common movement disorder[3]. It is characterized by an isolated upper limb action tremor of at least three years’ duration without other neurological signs, although some patients may exhibit a range of other symptoms and signs.

[1] https://www.zorginstituutnederland.nl/publicaties/standpunten/2023/12/12/standpunt-hifu
[2] MSAC Public Summary Document. Application No. 1614 – Magnetic resonance-guided focused ultrasound for the treatment of medically refractory essential tremor. Insightec Ltd. Available at https://www.msac.gov.au/internet/msac/publishing.nsf/Content/17E39DC9F1DE6FB4CA25850B00045325/$File/1614%20Final%20PSD%20-%20Mar-Apr%202021_redacted.pdf (accessed August 2023)
[3] Louis ED, McCreary M. How Common is Essential Tremor? Update on the Worldwide Prevalence of Essential Tremor. Tremor and Other Hyperkinetic Movements. 2021; 11(1): 28, pp. 1–14. DOI: https://doi.org/10.5334/tohm.632

SourceInsightec

Hot this week

Cartessa Aesthetics Partners with Classys to Bring EVERESSE to the U.S. Market

Classys, which is listed on the KOSDAQ, is one of South Korea's most distinguished aesthetic technology manufacturers, with devices distributed in 80+ markets globally. This partnership marks Classys's official entry into the American marketplace, with Cartessa Aesthetics as the exclusive distributor for EVERESSE, launched under the Volnewmer brand in current global markets.

Stryker Launches Next-Generation of SurgiCount+

Now integrated with Stryker's Triton technology, SurgiCount+ addresses two key challenges: retained surgical sponges and blood loss assessment. Integrating these previously separate digital solutions provides the added benefit of a more efficient, streamlined workflow for hospitals notes Stryker.

Nevro Receives CE Mark In Europe for It’s HFX iQ™ Spinal Cord Stimulation System

Nevro notes HFX iQ is the first and only SCS system with artificial intelligence (AI) technology that combines high-frequency (10 kHz) therapy built on landmark evidence that uses ongoing cloud data insights to deliver personalized pain relief

Recor Medical Reports: CMS Grants Distinct TPT Device Code and Category to Recor Medical for Ultrasound Renal Denervation

The approval of TPT offers incremental reimbursement payments for outpatient procedures performed with ultrasound renal denervation for Medicare fee-for-service beneficiaries. It becomes effective January 1, 2025, and is expected to remain effective for up to three years notes Recor Medical.

Jupiter Endovascular Reports | 1st U.S. Patient Treated with Jupiter Shape-shifting Thrombectomy Device

“Navigation challenges during endovascular procedures are often underappreciated and have led to under-adoption of life-saving procedures, such as pulmonary embolectomy. We have purpose-built our Endoportal Control technology to solve these issues and make important endovascular procedures accessible to more clinicians and their patients who can benefit from them,” said Carl J. St. Bernard, Jupiter Endovascular CEO. “This first case in the U.S. could not have gone better, and appears to validate the safety and performance we are seeing in our currently-enrolling European SPIRARE I study.”
Exit mobile version