<p>truFlex 的下一次进化巩固了其作为康复多功能解决方案的地位，新增了腹部、手臂、小腿、臀部和大腿的功能性力量应用。</p>
<p>, /PRNewswire/ -- CUTERA, INC.，一家领先的美学和皮肤病解决方案提供商，今天宣布美国食品药品监督管理局（FDA）已批准其 truFlex 肌肉刺激技术的扩展适应症。这一扩展许可使 truFlex 不仅限于美学用途，还增加了康复和治疗应用，并为手臂和小腿开辟了新的治疗领域。</p>
<p>“新的 truFlex 适应症反映了我们在肌肉康复和功能性力量方面的重大进展。其精确性和定制化使其成为支持患者在健康和康复旅程各个阶段的卓越方式。我对这对我的患者意味着什么以及它将在我的实践中产生的重大影响感到振奋，” Restimulate Health 的首席执行官兼创始人 Edward Alvarez 博士表示。</p>
<p><strong>新扩展的适应症包括：</strong></p>
<ul>
<li>加强、塑形和紧致手臂和小腿</li>
<li>放松肌肉痉挛</li>
<li>预防或延缓不使用性萎缩</li>
<li>增加局部血液循环</li>
<li>肌肉再教育</li>
<li>维持或增加活动范围</li>
<li>手术后立即刺激小腿肌肉以防止静脉血栓形成</li>
<li>刺激神经肌肉组织以实现腿部或手臂的肌肉兴奋，供康复用途</li>
<li>作为医疗疾病和状况治疗的辅助疗法（需在医疗监督下使用）</li>
</ul>
<p>“康复和肌肉健康代表了当今医疗技术中两个最令人兴奋的增长领域。这些新的许可标志着 Cutera 在通过先进的多功能解决方案改善患者生活方面的重要里程碑，这些解决方案同时满足美学和治疗需求，” Cutera 首席执行官 Taylor Harris 表示。“通过将 truFlex 的用途扩展到康复和恢复，我们为提供者开辟了新的机会，以支持患者在更广泛的护理范围内。”</p>
<p>truFlex 于 2019 年推向市场，采用专有的多方向刺激（MDS）技术，通过定制的施用器向目标肌肉群传递能量，以诱导受控的肌肉收缩，适应患者的体型或目标治疗区域。通过这一许可，Cutera 现在可以与医生、康复专家和其他提供者合作，提供扩展的益处，以支持患者的健康和临床结果。</p>
<p>有关 Cutera 的 truFlex 的更多信息，感兴趣的提供者可以访问 https://cutera.com/us-en/products/truflex/。希望了解更多或寻找 truFlex 提供者的患者可以访问 www.yourtrubody.com。</p>
<p><strong>关于 Cutera, Inc.</strong> Cutera 是一家领先的全球美学和皮肤病解决方案提供商。25 年来，Cutera 致力于通过科学驱动的医疗美学技术和合作伙伴关系改善生活。有关更多信息，请致电 1-888-4-CUTERA 或访问 Cutera.com。</p>
<p><strong>truFlex 重要安全信息：</strong></p>
<p><strong>适应症：</strong> truFlex 适用于改善腹部肌肉的紧致度，增强腹部肌肉，发展更紧致的腹部；加强、塑形和紧致手臂、臀部、大腿和小腿；预防或延缓不使用性萎缩；肌肉再教育；刺激神经肌肉组织以实现腿部或手臂的肌肉兴奋，供康复用途；在医疗监督下用于医疗疾病和状况治疗的辅助疗法。</p>
<p><strong>重要安全信息</strong>：在使用 truFlex 治疗期间或之后，可能会出现以下与治疗相关的预期短暂副作用和可能的不良事件：心率增加、皮肤刺激/过敏反应、过敏性皮肤反应、不适/疼痛和肌肉酸痛、淤血、随机肌肉收缩、频繁排尿/肠道刺激、增加。</p>
<p><strong>禁忌症：</strong> 患有心脏起搏器、除颤器或其他植入电子设备的患者；治疗区域下的金属植入物；癫痫；癌性病变；急性创伤或骨折；近期手术；腹部或腹股沟疝；下肢严重缺血；血流不足/静脉血栓。</p>
<p><strong>警告：</strong> 未经医生评估，不得治疗以下患者：孕妇（在怀孕或分娩期间刺激的安全性尚未确定）；已知心肌心律失常的患者；腹部、肠道或肠道区域有慢性疾病的患者（如克罗恩病、结肠炎、格雷夫斯病等）。不得经胸部（胸部或上背部）进行治疗。将电流引入心脏可能导致心律失常。不得经头部进行治疗。不得在面部或颈部进行治疗。可能会发生喉部和咽部肌肉的严重痉挛，导致气道闭合和呼吸困难。不得在肿胀、感染或发炎区域或皮肤病变（如静脉炎、血栓性静脉炎、静脉曲张）上进行治疗。不得在金属植入物上进行治疗。</p>
<p><strong>注意事项</strong>：在治疗有心脏问题怀疑或诊断的患者时要谨慎；在急性创伤或骨折后有出血倾向的患者；在最近进行过手术的患者，肌肉收缩可能会干扰愈合过程；在月经期间的子宫上；在缺乏正常感觉的皮肤区域上。治疗期间始终与患者保持口头联系。切勿让患者无人看管。在 truFlex 过程中不要使用任何麻醉剂（包括吸入麻醉剂）。患者反馈对于确定最佳治疗水平和帮助防止不良反应是必要的。局部麻醉剂也可能损坏手持设备。对医疗植入物的治疗反应尚不清楚。在确定患者是否适合治疗之前，请咨询植入物制造商或开处方医生。</p>
<p>腹部或腹股沟疝气患者禁忌治疗。此外，对于曾经进行过疝气修复的患者或有未诊断或怀疑疝气的患者，应给予谨慎对待，因为他们的情况是禁忌的。曾进行疝气修复的患者在进行 truFlex 治疗之前应咨询医生。在进行 truFlex 治疗之前，评估患者是否有潜在的未诊断疝气。可在 MyCutera.com 上获取可选的疝气风险预筛查问卷，或提供者可以使用临床判断或其他方法。将有识别风险因素的患者转诊给医生进行进一步评估。治疗应在患者获得医学许可后进行。指导患者在治疗前后 24 小时内避免任何剧烈运动或对治疗肌肉的运动。老年人在开始使用 truFlex 设备治疗之前应获得医生的许可，类似于开始新的锻炼计划。老年人可能更容易受到潜在疾病（例如，疝气、心律失常或其他健康问题）的影响，这些问题可能是禁忌或在治疗前需要额外的医学评估。</p>
<p>在使用 truFlex 进行康复和恢复时，请咨询您的医疗服务提供者，个人结果和体验可能会有所不同。</p>
<p><strong>联系方式</strong> <strong>媒体</strong>：EvolveMKD</p>
<p>[email protected]</p>
<p>来源 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. 宣布，FDA 已批准其 truFlex 肌肉刺激技术的扩展适应症。新的许可允许 truFlex 用于康复和治疗应用，包括增强、塑形和紧致手臂和小腿、肌肉再教育以及预防不使用性萎缩。这一扩展支持了美学和治疗的需求，提升了患者的健康和临床结果</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 的下一次进化巩固了其作为康复多功能解决方案的地位，新增了腹部、手臂、小腿、臀部和大腿的功能性力量应用。</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.，一家领先的美学和皮肤病解决方案提供商，今天宣布美国食品药品监督管理局（FDA）已批准其 truFlex 肌肉刺激技术的扩展适应症。这一扩展许可使 truFlex 不仅限于美学用途，还增加了康复和治疗应用，并为手臂和小腿开辟了新的治疗领域。</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 适应症反映了我们在肌肉康复和功能性力量方面的重大进展。其精确性和定制化使其成为支持患者在健康和康复旅程各个阶段的卓越方式。我对这对我的患者意味着什么以及它将在我的实践中产生的重大影响感到振奋，” Restimulate Health 的首席执行官兼创始人 Edward Alvarez 博士表示。</p>
</div><p><strong>The newly expanded indications include:</strong></p>
<div class="lb-trans"><p><strong>新扩展的适应症包括：</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>加强、塑形和紧致手臂和小腿</li>
<li>放松肌肉痉挛</li>
<li>预防或延缓不使用性萎缩</li>
<li>增加局部血液循环</li>
<li>肌肉再教育</li>
<li>维持或增加活动范围</li>
<li>手术后立即刺激小腿肌肉以防止静脉血栓形成</li>
<li>刺激神经肌肉组织以实现腿部或手臂的肌肉兴奋，供康复用途</li>
<li>作为医疗疾病和状况治疗的辅助疗法（需在医疗监督下使用）</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>“康复和肌肉健康代表了当今医疗技术中两个最令人兴奋的增长领域。这些新的许可标志着 Cutera 在通过先进的多功能解决方案改善患者生活方面的重要里程碑，这些解决方案同时满足美学和治疗需求，” Cutera 首席执行官 Taylor Harris 表示。“通过将 truFlex 的用途扩展到康复和恢复，我们为提供者开辟了新的机会，以支持患者在更广泛的护理范围内。”</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 于 2019 年推向市场，采用专有的多方向刺激（MDS）技术，通过定制的施用器向目标肌肉群传递能量，以诱导受控的肌肉收缩，适应患者的体型或目标治疗区域。通过这一许可，Cutera 现在可以与医生、康复专家和其他提供者合作，提供扩展的益处，以支持患者的健康和临床结果。</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>有关 Cutera 的 truFlex 的更多信息，感兴趣的提供者可以访问 https://cutera.com/us-en/products/truflex/。希望了解更多或寻找 truFlex 提供者的患者可以访问 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>关于 Cutera, Inc.</strong> Cutera 是一家领先的全球美学和皮肤病解决方案提供商。25 年来，Cutera 致力于通过科学驱动的医疗美学技术和合作伙伴关系改善生活。有关更多信息，请致电 1-888-4-CUTERA 或访问 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>适应症：</strong> truFlex 适用于改善腹部肌肉的紧致度，增强腹部肌肉，发展更紧致的腹部；加强、塑形和紧致手臂、臀部、大腿和小腿；预防或延缓不使用性萎缩；肌肉再教育；刺激神经肌肉组织以实现腿部或手臂的肌肉兴奋，供康复用途；在医疗监督下用于医疗疾病和状况治疗的辅助疗法。</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 治疗期间或之后，可能会出现以下与治疗相关的预期短暂副作用和可能的不良事件：心率增加、皮肤刺激/过敏反应、过敏性皮肤反应、不适/疼痛和肌肉酸痛、淤血、随机肌肉收缩、频繁排尿/肠道刺激、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> 患有心脏起搏器、除颤器或其他植入电子设备的患者；治疗区域下的金属植入物；癫痫；癌性病变；急性创伤或骨折；近期手术；腹部或腹股沟疝；下肢严重缺血；血流不足/静脉血栓。</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> 未经医生评估，不得治疗以下患者：孕妇（在怀孕或分娩期间刺激的安全性尚未确定）；已知心肌心律失常的患者；腹部、肠道或肠道区域有慢性疾病的患者（如克罗恩病、结肠炎、格雷夫斯病等）。不得经胸部（胸部或上背部）进行治疗。将电流引入心脏可能导致心律失常。不得经头部进行治疗。不得在面部或颈部进行治疗。可能会发生喉部和咽部肌肉的严重痉挛，导致气道闭合和呼吸困难。不得在肿胀、感染或发炎区域或皮肤病变（如静脉炎、血栓性静脉炎、静脉曲张）上进行治疗。不得在金属植入物上进行治疗。</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>注意事项</strong>：在治疗有心脏问题怀疑或诊断的患者时要谨慎；在急性创伤或骨折后有出血倾向的患者；在最近进行过手术的患者，肌肉收缩可能会干扰愈合过程；在月经期间的子宫上；在缺乏正常感觉的皮肤区域上。治疗期间始终与患者保持口头联系。切勿让患者无人看管。在 truFlex 过程中不要使用任何麻醉剂（包括吸入麻醉剂）。患者反馈对于确定最佳治疗水平和帮助防止不良反应是必要的。局部麻醉剂也可能损坏手持设备。对医疗植入物的治疗反应尚不清楚。在确定患者是否适合治疗之前，请咨询植入物制造商或开处方医生。</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>腹部或腹股沟疝气患者禁忌治疗。此外，对于曾经进行过疝气修复的患者或有未诊断或怀疑疝气的患者，应给予谨慎对待，因为他们的情况是禁忌的。曾进行疝气修复的患者在进行 truFlex 治疗之前应咨询医生。在进行 truFlex 治疗之前，评估患者是否有潜在的未诊断疝气。可在 MyCutera.com 上获取可选的疝气风险预筛查问卷，或提供者可以使用临床判断或其他方法。将有识别风险因素的患者转诊给医生进行进一步评估。治疗应在患者获得医学许可后进行。指导患者在治疗前后 24 小时内避免任何剧烈运动或对治疗肌肉的运动。老年人在开始使用 truFlex 设备治疗之前应获得医生的许可，类似于开始新的锻炼计划。老年人可能更容易受到潜在疾病（例如，疝气、心律失常或其他健康问题）的影响，这些问题可能是禁忌或在治疗前需要额外的医学评估。</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 进行康复和恢复时，请咨询您的医疗服务提供者，个人结果和体验可能会有所不同。</p>
</div><p><strong>Contacts</strong> <strong>Media:</strong> EvolveMKD</p>
<div class="lb-trans"><p><strong>联系方式</strong> <strong>媒体</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>来源 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®宣布 truFlex®获得新的 FDA 批准，用于支持康复、恢复和肌肉健康