<p>truFlex 的下一次進化鞏固了其作為康復多功能解決方案的地位，新增了腹部、手臂、小腿、臀部和大腿的功能性力量應用。</p>
<p>, /PRNewswire/ -- CUTERA, INC.，一家領先的美學和皮膚病解決方案提供商，今天宣佈美國食品藥品監督管理局（FDA）已批准其 truFlex 肌肉刺激技術的擴展適應症。這一擴展許可使 truFlex 不僅限於美學用途，還增加了康復和治療應用，併為手臂和小腿開闢了新的治療領域。</p>
<p>“新的 truFlex 適應症反映了我們在肌肉康復和功能性力量方面的重大進展。其精確性和定製化使其成為支持患者在健康和康復旅程各個階段的卓越方式。我對這對我的患者意味着什麼以及它將在我的實踐中產生的重大影響感到振奮，” Restimulate Health 的首席執行官兼創始人 Edward Alvarez 博士表示。</p>
<p><strong>新擴展的適應症包括：</strong></p>
<ul>
<li>加強、塑形和緊緻手臂和小腿</li>
<li>放鬆肌肉痙攣</li>
<li>預防或延緩不使用性萎縮</li>
<li>增加局部血液循環</li>
<li>肌肉再教育</li>
<li>維持或增加活動範圍</li>
<li>手術後立即刺激小腿肌肉以防止靜脈血栓形成</li>
<li>刺激神經肌肉組織以實現腿部或手臂的肌肉興奮，供康復用途</li>
<li>作為醫療疾病和狀況治療的輔助療法（需在醫療監督下使用）</li>
</ul>
<p>“康復和肌肉健康代表了當今醫療技術中兩個最令人興奮的增長領域。這些新的許可標誌着 Cutera 在通過先進的多功能解決方案改善患者生活方面的重要里程碑，這些解決方案同時滿足美學和治療需求，” Cutera 首席執行官 Taylor Harris 表示。“通過將 truFlex 的用途擴展到康復和恢復，我們為提供者開闢了新的機會，以支持患者在更廣泛的護理範圍內。”</p>
<p>truFlex 於 2019 年推向市場，採用專有的多方向刺激（MDS）技術，通過定製的施用器向目標肌肉羣傳遞能量，以誘導受控的肌肉收縮，適應患者的體型或目標治療區域。通過這一許可，Cutera 現在可以與醫生、康復專家和其他提供者合作，提供擴展的益處，以支持患者的健康和臨牀結果。</p>
<p>有關 Cutera 的 truFlex 的更多信息，感興趣的提供者可以訪問 https://cutera.com/us-en/products/truflex/。希望瞭解更多或尋找 truFlex 提供者的患者可以訪問 www.yourtrubody.com。</p>
<p><strong>關於 Cutera, Inc.</strong> Cutera 是一家領先的全球美學和皮膚病解決方案提供商。25 年來，Cutera 致力於通過科學驅動的醫療美學技術和合作夥伴關係改善生活。有關更多信息，請致電 1-888-4-CUTERA 或訪問 Cutera.com。</p>
<p><strong>truFlex 重要安全信息：</strong></p>
<p><strong>適應症：</strong> truFlex 適用於改善腹部肌肉的緊緻度，增強腹部肌肉，發展更緊緻的腹部；加強、塑形和緊緻手臂、臀部、大腿和小腿；預防或延緩不使用性萎縮；肌肉再教育；刺激神經肌肉組織以實現腿部或手臂的肌肉興奮，供康復用途；在醫療監督下用於醫療疾病和狀況治療的輔助療法。</p>
<p><strong>重要安全信息</strong>：在使用 truFlex 治療期間或之後，可能會出現以下與治療相關的預期短暫副作用和可能的不良事件：心率增加、皮膚刺激/過敏反應、過敏性皮膚反應、不適/疼痛和肌肉痠痛、淤血、隨機肌肉收縮、頻繁排尿/腸道刺激、增加。</p>
<p><strong>禁忌症：</strong> 患有心臟起搏器、除顫器或其他植入電子設備的患者；治療區域下的金屬植入物；癲癇；癌性病變；急性創傷或骨折；近期手術；腹部或腹股溝疝；下肢嚴重缺血；血流不足/靜脈血栓。</p>
<p><strong>警告：</strong> 未經醫生評估，不得治療以下患者：孕婦（在懷孕或分娩期間刺激的安全性尚未確定）；已知心肌心律失常的患者；腹部、腸道或腸道區域有慢性疾病的患者（如克羅恩病、結腸炎、格雷夫斯病等）。不得經胸部（胸部或上背部）進行治療。將電流引入心臟可能導致心律失常。不得經頭部進行治療。不得在面部或頸部進行治療。可能會發生喉部和咽部肌肉的嚴重痙攣，導致氣道閉合和呼吸困難。不得在腫脹、感染或發炎區域或皮膚病變（如靜脈炎、血栓性靜脈炎、靜脈曲張）上進行治療。不得在金屬植入物上進行治療。</p>
<p><strong>注意事項</strong>：在治療有心臟問題懷疑或診斷的患者時要謹慎；在急性創傷或骨折後有出血傾向的患者；在最近進行過手術的患者，肌肉收縮可能會干擾癒合過程；在月經期間的子宮上；在缺乏正常感覺的皮膚區域上。治療期間始終與患者保持口頭聯繫。切勿讓患者無人看管。在 truFlex 過程中不要使用任何麻醉劑（包括吸入麻醉劑）。患者反饋對於確定最佳治療水平和幫助防止不良反應是必要的。局部麻醉劑也可能損壞手持設備。對醫療植入物的治療反應尚不清楚。在確定患者是否適合治療之前，請諮詢植入物製造商或開處方醫生。</p>
<p>腹部或腹股溝疝氣患者禁忌治療。此外，對於曾經進行過疝氣修復的患者或有未診斷或懷疑疝氣的患者，應給予謹慎對待，因為他們的情況是禁忌的。曾進行疝氣修復的患者在進行 truFlex 治療之前應諮詢醫生。在進行 truFlex 治療之前，評估患者是否有潛在的未診斷疝氣。可在 MyCutera.com 上獲取可選的疝氣風險預篩查問卷，或提供者可以使用臨牀判斷或其他方法。將有識別風險因素的患者轉診給醫生進行進一步評估。治療應在患者獲得醫學許可後進行。指導患者在治療前後 24 小時內避免任何劇烈運動或對治療肌肉的運動。老年人在開始使用 truFlex 設備治療之前應獲得醫生的許可，類似於開始新的鍛鍊計劃。老年人可能更容易受到潛在疾病（例如，疝氣、心律失常或其他健康問題）的影響，這些問題可能是禁忌或在治療前需要額外的醫學評估。</p>
<p>在使用 truFlex 進行康復和恢復時，請諮詢您的醫療服務提供者，個人結果和體驗可能會有所不同。</p>
<p><strong>聯繫方式</strong> <strong>媒體</strong>：EvolveMKD</p>
<p>[email protected]</p>
<p>來源 Cutera</p>
<p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjUxMjE4Jk5ld3NJdGVtSWQ9Tlk0OTg3NSZUcmFuc21pc3Npb25fSWQ9MjAyNTEyMTgwODAxUFJfTkVXU19VU1BSX19fX19OWTQ5ODc1?x-oss-process=image/auto-orient,1/interlace,1/resize,w_1440,h_1440/quality,q_95/format,jpg" alt="" original-src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjUxMjE4Jk5ld3NJdGVtSWQ9Tlk0OTg3NSZUcmFuc21pc3Npb25fSWQ9MjAyNTEyMTgwODAxUFJfTkVXU19VU1BSX19fX19OWTQ5ODc1"/></p>

CUTRQ

<p>Cutera, Inc. 宣佈，FDA 已批准其 truFlex 肌肉刺激技術的擴展適應症。新的許可允許 truFlex 用於康復和治療應用，包括增強、塑形和緊緻手臂和小腿、肌肉再教育以及預防不使用性萎縮。這一擴展支持了美學和治療的需求，提升了患者的健康和臨牀結果</p>

<p><em>The next evolution of truFlex fortifies its position as a versatile solution for rehabilitation with new applications in functional strength for the abdomen, arms, calves, glutes and thighs.</em></p>
<div class="lb-trans"><p>truFlex 的下一次進化鞏固了其作為康復多功能解決方案的地位，新增了腹部、手臂、小腿、臀部和大腿的功能性力量應用。</p>
</div><p>, /PRNewswire/ -- CUTERA, INC., a leading provider in aesthetic, dermatological solutions, today announced that the U.S. Food and Drug Administration (FDA) has granted expanded indications for its truFlex muscle stimulation technology. This expanded clearance moves truFlex beyond aesthetic use alone, adding rehabilitative and therapeutic applications and opening new treatment areas for the arms and calves.</p>
<div class="lb-trans"><p>, /PRNewswire/ -- CUTERA, INC.，一家領先的美學和皮膚病解決方案提供商，今天宣佈美國食品藥品監督管理局（FDA）已批准其 truFlex 肌肉刺激技術的擴展適應症。這一擴展許可使 truFlex 不僅限於美學用途，還增加了康復和治療應用，併為手臂和小腿開闢了新的治療領域。</p>
</div><p>&#34;The new truFlex indications reflect a major advancement in how we approach muscle rehabilitation and functional strength. Its precision and customization make it an exceptional modality for supporting patients at every stage of their wellness and rehabilitation journey. I'm energized by what this means for my patients and the meaningful impact it will have in my practice,&#34; said Dr. Edward Alvarez, CEO and Founder of Restimulate Health.</p>
<div class="lb-trans"><p>“新的 truFlex 適應症反映了我們在肌肉康復和功能性力量方面的重大進展。其精確性和定製化使其成為支持患者在健康和康復旅程各個階段的卓越方式。我對這對我的患者意味着什麼以及它將在我的實踐中產生的重大影響感到振奮，” Restimulate Health 的首席執行官兼創始人 Edward Alvarez 博士表示。</p>
</div><p><strong>The newly expanded indications include:</strong></p>
<div class="lb-trans"><p><strong>新擴展的適應症包括：</strong></p>
</div><ul>
<li>Strengthening, toning, and firming of arms and calves</li>
<li>Relaxation of muscle spasms</li>
<li>Prevention or retardation of disuse atrophy</li>
<li>Increasing local blood circulation</li>
<li>Muscle re-education</li>
<li>Maintaining or increasing range of motion</li>
<li>Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis</li>
<li>Stimulation of neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes</li>
<li>Adjunctive therapy for the treatment of medical diseases and conditions (to be used under medical supervision)</li>
</ul>
<div class="lb-trans"><ul>
<li>加強、塑形和緊緻手臂和小腿</li>
<li>放鬆肌肉痙攣</li>
<li>預防或延緩不使用性萎縮</li>
<li>增加局部血液循環</li>
<li>肌肉再教育</li>
<li>維持或增加活動範圍</li>
<li>手術後立即刺激小腿肌肉以防止靜脈血栓形成</li>
<li>刺激神經肌肉組織以實現腿部或手臂的肌肉興奮，供康復用途</li>
<li>作為醫療疾病和狀況治療的輔助療法（需在醫療監督下使用）</li>
</ul>
</div><p>&#34;Rehabilitation and muscle wellness represent two of the most exciting growth areas in medical technology today. These new clearances mark an important milestone in Cutera's mission to improve the lives of patients through advanced, versatile solutions that address both aesthetic and therapeutic demand,&#34; said Taylor Harris, CEO of Cutera. &#34;By extending truFlex's uses into rehabilitation and recovery, we are opening new opportunities for providers to support patients across a broader spectrum of care.&#34;</p>
<div class="lb-trans"><p>“康復和肌肉健康代表了當今醫療技術中兩個最令人興奮的增長領域。這些新的許可標誌着 Cutera 在通過先進的多功能解決方案改善患者生活方面的重要里程碑，這些解決方案同時滿足美學和治療需求，” Cutera 首席執行官 Taylor Harris 表示。“通過將 truFlex 的用途擴展到康復和恢復，我們為提供者開闢了新的機會，以支持患者在更廣泛的護理範圍內。”</p>
</div><p>truFlex was introduced to the market in 2019 and is powered by proprietary Multi-Directional Stimulation (MDS) technology to induce controlled muscle contractions in targeted muscle groups by delivering energy through applicators that can be customized to a patient's body shape or targeted treatment area. With this clearance, Cutera can now partner with physicians, rehabilitation specialists, and other providers to deliver expanded benefits that support both patient wellness and clinical outcomes.</p>
<div class="lb-trans"><p>truFlex 於 2019 年推向市場，採用專有的多方向刺激（MDS）技術，通過定製的施用器向目標肌肉羣傳遞能量，以誘導受控的肌肉收縮，適應患者的體型或目標治療區域。通過這一許可，Cutera 現在可以與醫生、康復專家和其他提供者合作，提供擴展的益處，以支持患者的健康和臨牀結果。</p>
</div><p>For further information on truFlex by Cutera interested providers can visit https://cutera.com/us-en/products/truflex/. Patients who would like to learn more or search for a truFlex provider can visit www.yourtrubody.com.</p>
<div class="lb-trans"><p>有關 Cutera 的 truFlex 的更多信息，感興趣的提供者可以訪問 https://cutera.com/us-en/products/truflex/。希望瞭解更多或尋找 truFlex 提供者的患者可以訪問 www.yourtrubody.com。</p>
</div><p><strong>About Cutera, Inc.</strong> Cutera is a leading provider of aesthetic and dermatology solutions for practitioners worldwide. For over 25 years, Cutera strives to improve lives through medical aesthetic technologies that are driven by science and powered through partnerships. For more information, call 1-888-4-CUTERA or visit Cutera.com.</p>
<div class="lb-trans"><p><strong>關於 Cutera, Inc.</strong> Cutera 是一家領先的全球美學和皮膚病解決方案提供商。25 年來，Cutera 致力於通過科學驅動的醫療美學技術和合作夥伴關係改善生活。有關更多信息，請致電 1-888-4-CUTERA 或訪問 Cutera.com。</p>
</div><p><strong>truFlex Important Safety Information:</strong></p>
<div class="lb-trans"><p><strong>truFlex 重要安全信息：</strong></p>
</div><p><strong>Indications for Use:</strong> truFlex is indicated for the improvement of abdominal tone, for strengthening of the abdominal muscles, for development of firmer abdomen; strengthening, toning, and firming of arms, buttocks, thighs, and calves; prevention or retardation of disuse atrophy; muscle re-education; stimulation of neuromuscular tissue for bulk muscle excitation in the legs or arms for rehabilitative purposes; to be used under medical supervision for adjunctive therapy for the treatment of medical diseases and conditions.</p>
<div class="lb-trans"><p><strong>適應症：</strong> truFlex 適用於改善腹部肌肉的緊緻度，增強腹部肌肉，發展更緊緻的腹部；加強、塑形和緊緻手臂、臀部、大腿和小腿；預防或延緩不使用性萎縮；肌肉再教育；刺激神經肌肉組織以實現腿部或手臂的肌肉興奮，供康復用途；在醫療監督下用於醫療疾病和狀況治療的輔助療法。</p>
</div><p><strong>Important Safety Information</strong>: The following treatment-related expected transient side effects and possible adverse events may occur during or following treatment with truFlex: Increased heart rate, skin irritation/hypersensitivity, allergic skin reaction, discomfort/pain and muscle soreness, bruising, random muscle contraction, frequent urination/bowel stimulation, increased.</p>
<div class="lb-trans"><p><strong>重要安全信息</strong>：在使用 truFlex 治療期間或之後，可能會出現以下與治療相關的預期短暫副作用和可能的不良事件：心率增加、皮膚刺激/過敏反應、過敏性皮膚反應、不適/疼痛和肌肉痠痛、淤血、隨機肌肉收縮、頻繁排尿/腸道刺激、增加。</p>
</div><p><strong>Contraindications:</strong> Patients with cardiac pacemakers, defibrillators, or other implanted electronic devices; Metallic implants under the treatment area; Epilepsy; Cancerous lesions; Acute trauma or fracture; Recent surgical procedures; Abdominal or inguinal hernia; Critical ischemia of lower limbs; Blood flow deficiencies/venous thrombosis.</p>
<div class="lb-trans"><p><strong>禁忌症：</strong> 患有心臟起搏器、除顫器或其他植入電子設備的患者；治療區域下的金屬植入物；癲癇；癌性病變；急性創傷或骨折；近期手術；腹部或腹股溝疝；下肢嚴重缺血；血流不足/靜脈血栓。</p>
</div><p><strong>Warnings:</strong> Do not treat the following patients without physician evaluation: Pregnant patients (Safety of stimulation during pregnancy or delivery has not been established); patients with known myocardial arrhythmia, patients who have chronic conditions in the abdomen, gut or intestinal areas (i.e. Crohn's disease, Colitis, Graves' disease, etc.). Do not treat transthoracically (on the chest or upper back). The introduction of electrical current into the heart may cause cardiac arrhythmia. Do not treat transcerebrally (on the head). Do not treat over the face or neck. Severe spasming of the laryngeal and pharyngeal muscles may occur, closing the airway and causing difficulty breathing. Do not treat over swollen, infected, or inflamed areas or skin eruptions (i.e. phlebitis, thrombophlebitis, varicose veins). Do not treat over metallic implants.</p>
<div class="lb-trans"><p><strong>警告：</strong> 未經醫生評估，不得治療以下患者：孕婦（在懷孕或分娩期間刺激的安全性尚未確定）；已知心肌心律失常的患者；腹部、腸道或腸道區域有慢性疾病的患者（如克羅恩病、結腸炎、格雷夫斯病等）。不得經胸部（胸部或上背部）進行治療。將電流引入心臟可能導致心律失常。不得經頭部進行治療。不得在面部或頸部進行治療。可能會發生喉部和咽部肌肉的嚴重痙攣，導致氣道閉合和呼吸困難。不得在腫脹、感染或發炎區域或皮膚病變（如靜脈炎、血栓性靜脈炎、靜脈曲張）上進行治療。不得在金屬植入物上進行治療。</p>
</div><p><strong>Precautions</strong>: Use caution when treating patients with suspected or diagnosed heart problems; patients who have a tendency to hemorrhage following acute trauma or fracture; patients following recent surgical procedures when muscle contraction may disrupt the healing process; over the menstruating uterus; over areas of the skin that lack normal sensation. Always keep verbal contact with the patient during therapy. Never leave the patient unattended. Do not use any anesthetic (including inhalation anesthetics) with truFlex procedures. Patient feedback is necessary to determine optimal treatment levels and to help prevent adverse reactions. Topical anesthetics may also damage the handpiece. Reaction to treating over medical implants is unknown. Consult with the implant manufacturer or prescribing physician before determining if the patient is a candidate for treatment.</p>
<div class="lb-trans"><p><strong>注意事項</strong>：在治療有心臟問題懷疑或診斷的患者時要謹慎；在急性創傷或骨折後有出血傾向的患者；在最近進行過手術的患者，肌肉收縮可能會干擾癒合過程；在月經期間的子宮上；在缺乏正常感覺的皮膚區域上。治療期間始終與患者保持口頭聯繫。切勿讓患者無人看管。在 truFlex 過程中不要使用任何麻醉劑（包括吸入麻醉劑）。患者反饋對於確定最佳治療水平和幫助防止不良反應是必要的。局部麻醉劑也可能損壞手持設備。對醫療植入物的治療反應尚不清楚。在確定患者是否適合治療之前，請諮詢植入物製造商或開處方醫生。</p>
</div><p>Patients with abdominal or inguinal hernias are contraindicated for treatment. In addition, caution should be given to patients who have had hernia repair or patients who have undiagnosed or suspected hernias, as their condition is contraindicated. Patients who have had hernia repair should consult with their physician prior to truFlex treatment. Before administering truFlex treatment, assess patients for potential undiagnosed hernias. An optional Hernia Risk Pre-screening Questionnaire is available onMyCutera.com, or providers may use clinical judgment or alternative methods. Refer patients with identified risk factors to a physician for further evaluation. Treatment should not proceed unless the patient has been medically cleared. Instruct patients to avoid any strenuous exercise or exercise of the treated muscles for 24 hours prior to and after treatment. Older individuals should obtain clearance from a physician before beginning treatment with the truFlex device, similar to starting a new exercise regimen. Older individuals may be more susceptible to underlying conditions (e.g., hernias, cardiac arrhythmia, or other health concerns) that maybe contraindicated or require additional medical evaluation prior to treatment.</p>
<div class="lb-trans"><p>腹部或腹股溝疝氣患者禁忌治療。此外，對於曾經進行過疝氣修復的患者或有未診斷或懷疑疝氣的患者，應給予謹慎對待，因為他們的情況是禁忌的。曾進行疝氣修復的患者在進行 truFlex 治療之前應諮詢醫生。在進行 truFlex 治療之前，評估患者是否有潛在的未診斷疝氣。可在 MyCutera.com 上獲取可選的疝氣風險預篩查問卷，或提供者可以使用臨牀判斷或其他方法。將有識別風險因素的患者轉診給醫生進行進一步評估。治療應在患者獲得醫學許可後進行。指導患者在治療前後 24 小時內避免任何劇烈運動或對治療肌肉的運動。老年人在開始使用 truFlex 設備治療之前應獲得醫生的許可，類似於開始新的鍛鍊計劃。老年人可能更容易受到潛在疾病（例如，疝氣、心律失常或其他健康問題）的影響，這些問題可能是禁忌或在治療前需要額外的醫學評估。</p>
</div><p>Please consult your Healthcare Provider when using truFlex for rehabilitation and recovery, individual results and experiences may vary.</p>
<div class="lb-trans"><p>在使用 truFlex 進行康復和恢復時，請諮詢您的醫療服務提供者，個人結果和體驗可能會有所不同。</p>
</div><p><strong>Contacts</strong> <strong>Media:</strong> EvolveMKD</p>
<div class="lb-trans"><p><strong>聯繫方式</strong> <strong>媒體</strong>：EvolveMKD</p>
</div><p>[email protected]</p>
<div class="lb-trans"><p>[email protected]</p>
</div><p>SOURCE Cutera</p>
<div class="lb-trans"><p>來源 Cutera</p>
</div><p><img src="https://imageproxy.pbkrs.com/https://rt.prnewswire.com/rt.gif/query-RGF0ZUlkPTIwMjUxMjE4Jk5ld3NJdGVtSWQ9Tlk0OTg3NSZUcmFuc21pc3Npb25fSWQ9MjAyNTEyMTgwODAxUFJfTkVXU19VU1BSX19fX19OWTQ5ODc1" alt="" original-src="https://rt.prnewswire.com/rt.gif?NewsItemId=NY49875&amp;Transmission_Id=202512180801PR_NEWS_USPR_____NY49875&amp;DateId=20251218"/></p>

Cutera®宣佈 truFlex®獲得新的 FDA 批准，用於支持康復、恢復和肌肉健康