Allurion’s weight loss gastric balloon completed the first implantation in China at Hainan Ruijin Hospital on June 27, 2023. Overweight patients with a body mass index (BMI) greater than 27 can apply for this non-invasive treatment at the hospital.
China Med Device helped Allurion enter Hainan Real World Data program. We also connected Allurion with commercial partners. If you want to utilize the Hainan special policy for your innovative or life-saving devices, please email us at info@ChinaMedDevice.com.
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Hainan Special Policy
Hainan Boao Pilot Zone allows overseas unapproved medical devices, IVDs, drugs, with clinical urgency status to be used in China. For overseas manufacturers, while commercializing and selling their products, they can collect RWD through RWS in Hainan as local clinical evidence to support their national NMPA registration approval. The special program might fasten their China market access to 4 months.
56 imported devices and drugs were included in the two batches of real-world data program in Lecheng Pilot District, Hainan, starting from October 2020. The latest examples, which went through the RWD and secured national approval, include Boston Scientific’s Rezūm water vapor therapy equipment, Allergan’s glaucoma drainage system, and J&J’s femtosecond laser eye treatment system.
What’s the Device
The balloon is a soft, water-fillable capsule made with plant polyurethane. Doctors place it in the patient’s stomach to reduce the capacity of the stomach and help the person feel full faster and stay full for longer. While the balloon is in the stomach, it can help patients eat less, reducing food cravings by creating a feeling of fullness. After around four months, the balloon is deflated and excreted through the gastrointestinal tract.
Allurion gastric balloon does not require endoscopy, surgery, and anesthesia to be placed in the stomach, and patients can swallow it under the guidance of a doctor. Before the placement, it is in the form of a drug capsule. After the swallowing, the doctor injects the liquid through a catheter attached to the balloon. And then pull the catheter to separate it from the balloon and remove the catheter out of the body. It takes 15-20 minutes to place the balloon in the stomach. Combined with the health tracking, diet and physical excise plan, patients will achieve the goal of long-term weight loss.
How to Obtain RWD?
Hainan Boao is the first area in China where RWD can be widely used. NMPA issued the “Technical Guideline on Real World Data Used in Medical Device Clinical Evaluation (Trial Implementation)” on November 26, 2020. It specifies six ways to acquire RWD:
- Data derived from electronic health records (EHRs)
- Medical claims and billing data
- Data from product and disease registries
- Patient-generated data, including from in-home-use settings,
- Data gathered from other sources that can inform on health status, such as mobile devices.
- Data generated from the complete life cycle of the medical device: production, sales, transportation, storage, installation, use, maintenance, decommissioning, and disposal. The data includes acceptance reports, maintenance reports, user feedback, use environment, calibration records, operation log, image raw data, etc.
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- Source: https://chinameddevice.com/allurion-gastric-balloon-hainan/
