After being approved for marketing in China, the absorbable implantable balloon InSpace System (hereinafter referred to as InSpace absorbable implantable balloon) developed and produced by Stryker has made another major breakthrough. On September 20, after strict review by the National Medical Insurance Administration, the product obtained the medical insurance medical consumables code (hereinafter referred to as C code), laying the foundation for obtaining the qualification for online procurement in various provinces in the next step. In July this year, the Medical Device Technology Review Center of the State Food and Drug Administration approved the marketing application of InSpace absorbable implantable balloon in China for the treatment of huge, irreparable, full-thickness tears of rotator cuff tendons caused by trauma or degeneration. As the only shoulder joint implantable balloon approved for marketing in the world by 2024, the product can be implanted under the acromion through minimally invasive surgery to restore shoulder joint balance, relieve pain and increase mobility. The approval of InSpace absorbable implantable balloon in China marks the entry of minimally invasive surgery into the treatment of huge, irreparable rotator cuff tears.
"We are very pleased to launch the InSpace absorbable implantable balloon in China," said Mr. Zhang Shaobin, General Manager of Stryker China. "This marks another milestone in our commitment to providing innovative medical solutions to Chinese patients. In the future, Stryker will continue to accelerate the introduction of global innovations, improve the quality of life of Chinese patients, and promote the implementation of the "Healthy China 2030" strategy."

Rotator cuff injury is a common clinical shoulder disease, which refers to injuries to the muscles, tendons or ligaments around the shoulder joint. The most common cause of this disease is the gradual wear of tendon tissue over time. If it is not intervened in time, the rotator cuff injury often develops into a huge rotator cuff tear. Therefore, this disease is more common in the elderly and is the most common cause of shoulder pain and dysfunction. Globally, previous anatomical and epidemiological studies have found that the incidence of rotator cuff tears in people aged 50 is 13%, the incidence in people aged 60 is 20%, and the incidence in people aged 70 is 31%. As the global population continues to age, rotator cuff disease will gradually become an important social health issue in the future.

Rotator cuff tears can cause weakness and pain in the shoulder joint, making it impossible to complete many daily activities, such as combing hair or dressing. At night, the shoulder joint may even be painful and difficult to fall asleep. At present, the treatment options for giant irreparable rotator cuff tears mainly include upper joint capsule reconstruction and reverse shoulder replacement, which have problems such as large trauma, high surgical difficulty and high surgical costs. The burden of rotator cuff injury is heavy, which has caused a serious economic burden on society.

The InSpace absorbable implantable balloon consists of an implant and a deployer. It is quickly implanted through arthroscopic minimally invasive surgery. It immediately restores the subacromial space after surgery, helps restore shoulder joint balance, range of motion and function, and relieves pain.

Stryker's InSpace absorbable implantable balloon has been approved by regulators in many countries and regions and is widely used worldwide. So far, more than 41,000 patients have been cured. The safety and effectiveness of this product have been verified in many clinical studies, and related research results have been published in more than 30 top academic journals worldwide. At present, the treatment of giant irreparable rotator cuff tears is still a challenge for surgeons, and patients may need to go through a long and difficult recovery process. The InSpace absorbable implantable balloon provides a less invasive option than traditional repair methods, which can improve shoulder function and relieve pain.

In June 2021, the first absorbable shoulder balloon implantation surgery in China for the treatment of giant rotator cuff tears was successfully completed in the Boao Lecheng International Medical Tourism Pilot Zone in Hainan. A 58-year-old female patient with a giant rotator cuff tear had severe pain in her left shoulder for many years and gradually lost her basic life functions. Thanks to the pilot policy of the Lecheng Pilot Zone, the patient found a "good prescription" to treat her pain. 5 Stryker China's strategic layout of accelerating innovation introduction has enabled the world's leading innovative devices represented by the InSpace absorbable implantable balloon to be listed in major markets in the United States and Europe that year, and settled in Hainan, China through the pilot policy of expanding opening up. This month, the InSpace absorbable implantable balloon was successfully approved for listing in the Chinese market, bringing new treatment options to surgeons and shoulder injury patients.

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