FDA批准新型减肥医疗器械——Maestro Rechargeable System

一种新型植入设备已获批用于治疗成人肥胖，该设备可以向腹内迷走神经发送电子脉冲信号，为需要减肥手术治疗患者提供了一种创伤性更小的替代治疗方案，

美国FDA于2014年01月14日发布的声明中指出，“Maestro Rechargeable System是首款针对大脑和胃之间控制饥饿感和饱腹感神经通路的减肥治疗设备。”在此之前，FDA批准的最后一款用于治疗肥胖的设备是Realize gastric band，该设备于2007年09月获批上市。

Maestro Rechargeable System被批准用于年龄≥18岁且BMI至少在40~45kg/m2，或BMI虽在35~39.9kg/m2之间但合并肥胖相关合并症，例如高血压或高胆固醇血症，且过去5年期间曾尝试在一个受监督的减肥计划中进行减肥。

 Maestro Rechargeable System包括一个植入到侧胸壁的可充电式电子脉冲发射器、一个通过腹腔镜手术放置在腹部迷走神经周围的电极、以及连接两者的电引线组成。FDA声明中指数，“Maestro Rechargeable System通过间歇性向腹部迷走神经干发送电子脉冲信号发挥作用，该神经可以调节胃排空，并将信号传递给大脑，使人产生饥饿或者饱腹感。”此外，声明中也补充道，“众所周知，通过电子刺激可以阻断大脑与胃之间的神经活性，但是，通过使用该装置导致患者体重下降的特定机制目前还不清楚。”

EnteroMedics公司于2015年01月14日发布的一份声明中， Maestro Rechargeable System制造商EnteroMedics公司将这种通过Maestro 系统发挥减重作用的治疗方法称为“VBLOC 疗法”。 EnteroMedics公司希望 Maestro Rechargeable System能够在今年上市，并在有限制的条件下选择美国减重手术卓越中心认证的机构试用。

FDA是基于ReCharge研究的研究结果批准Maestro Rechargeable System上市。ReCharge研究共纳入233例BMI≥35kg/m2受试者，并给予受试者植入Maestro Rechargeable System，其中，157例受试者的Maestro Rechargeable System被激活；而剩余的患者虽然也植入了Maestro Rechargeable System，但没有被激活，并被视为对照组。

FDA声明中指出，治疗12个月之后，与对照组相比，那些Maestro Rechargeable System被激活的受试者多减重8.5%。而且，在那些Maestro Rechargeable System被激活的受试者中，接近53%受试者至少减重20%，且有38%受试者减重35%以上。

这项研究的主要有效性终点为，Maestro Rechargeable System被激活受试者至少能比对照组多减重10%以上。虽然最终未能达到主要有效性终点，但是，在2014年06月，FDA顾问小组召开了一场会议，在仔细评估这项研究的研究数据后，大多数成员支持Maestro Rechargeable System获批上市，肯定了Maestro Rechargeable System治疗适应症产生的获益超过其所带来的风险。同时，专家小组还指出，这项研究达到了预设的安全性终点，而且，Maestro Rechargeable System确实可有效辅助一些患者减重。

在一项由FDA进行的减肥设备患者喜好调查中，研究者发现，由于这种手术植入设备预计可带来显著的减重获益，大多数患者可以接受这种设备治疗所产生的相关风险。FDA声明中透露道，基于专家小组的建议、临床研究结果、以及这项项由FDA进行的减肥设备患者喜好调查研究结果，FDA最终做出了批准Maestro Rechargeable System上市的决定。

FDA指出，作为Maestro Rechargeable System获批上市的条件之一，FDA要求EnteroMedics公司进行一项为期5年的上市后研究。这项研究将收集至少100例患者的安全性和有效性数据，包括减重效果、不良事件、再次手术植入、以及患者肥胖相关合并症的变化。

同时，FDA也注意到，在ReCharge研究中，Maestro Rechargeable System治疗期间引起的严重不良事件包括恶心、神经调节位点疼痛、呕吐、以及手术并发症，其他不良事件还包括烧心、吞咽困难、嗳气、轻度恶心和胸痛。

EnteroMedics公司在声明中指出，VBLOC疗法的禁忌症包括肝硬化；门静脉高压；食管胃底静脉曲张；临床上显著的的食管裂孔疝；计划行磁共振检查或电热治疗的患者；手术并发症风险高的患者；以及电动医疗设备、胃肠设备或假体永久植入的患者，例如起搏器、植入型除颤器和神经刺激器。

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A novel implantable device that delivers electrical pulses to the intra-abdominal vagus nerve has been approved for treatment of obesity in adults, providing a less invasive alternative to bariatric surgery.

The Maestro Rechargeable System is “the first weight loss treatment device that targets the nerve pathway between the brain and the stomach that controls feelings of hunger and fullness,” according to the Food and Drug Administration statement released Jan. 14. The last device approved by the FDA for treatment of obesity was the Realize gastric band, in September 2007.

The device is approved for adults aged 18 and older with a body mass index of at least 40-45 kg/m2, or at least 35-39.9 kg/m2 with a related health condition such as high blood pressure or high cholesterol levels, who have tried to lose weight in a supervised weight management program within the past 5 years.

The system includes a rechargeable electrical pulse generator implanted into the lateral chest wall, connected to two electrical leads placed around the abdominal vagus nerve via a laparoscopic procedure. “It works by sending intermittent electrical pulses to the trunks in the abdominal vagus nerve, which is involved in regulating stomach emptying and signaling to the brain that the stomach feels empty or full,” the FDA statement said, adding: “Although it is known that the electric stimulation blocks nerve activity between the brain and the stomach, the specific mechanisms for weight loss due to use of the device are unknown.”

The manufacturer, EnteroMedics, refers to the treatment as “VBLOC therapy,” delivered by the Maestro System. The company expects that the device will be available this year “on a limited basis” at select Bariatric Centers of Excellence in the United States, according to astatement issued by EnteroMedics on Jan. 14.

FDA approval was based on the results of the ReCharge study of 233 patients with a body mass index of at least 35 kg/m2; the device was activated in 157 patients, and the remaining patients had the device implanted but it was not activated and they served as controls.

After 12 months, those with the activated device lost 8.5% more excess weight than did the controls. Among those who had the device activated, almost 53% lost at least 20% of their excess weight and 38% lost at least 35% of their excess weight, according to the FDA.

The study did not meet the primary effectiveness endpoint, which was that those on active treatment would lose at least 10% more excess weight than would the controls. However, the majority of an FDA advisory panel that reviewed the data at a meeting in June 2014 supported approval, agreeing that the benefits outweighed the risks for the proposed indication. Panelists cited the fact that the study safety endpoint was met and that the device was effective in helping some people lose weight.

The FDA statement said the decision to approve the device was based on the panel’s recommendation, the study results, and an FDA survey of patient preferences for obesity devices, which found that “a group of patients would accept risks associated with this surgically implanted device for the amounts of weight loss expected to be provided by the device.”

As a condition for approval, EnteroMedics is required to conduct a 5-year postmarketing study that will collect safety and effectiveness data in at least 100 patients, including weight loss, adverse events, surgical revisions and explants and changes in obesity-related comorbidities, according to the FDA.

Serious adverse events in the ReCharge study were nausea, pain at the neuroregulator site, vomiting, and surgical complications; other adverse events were heartburn, problems swallowing, belching, mild nausea, and chest pain, the FDA noted.

The EnteroMedics statement says that contraindications for VBLOC therapy include liver cirrhosis, portal hypertension, esophageal varices or an uncorrectable, clinically significant hiatal hernia; patients for whom magnetic resonance imaging or diathermy use is planned; patients at high risk for surgical complications; and patients who have permanently implanted, electrically-powered medical devices or gastrointestinal devices or prostheses, such as pacemakers, implanted defibrillators, or neurostimulators.

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