China NMPA Approves Tigertriever Revascularization Device For Market

On August 17, 2023, NMPA approved for the registration application of the Tigertriever Revascularization Device manufactured by Rapid Medical Ltd.

The product consists of a stentriever that is comprised of an adjustable nitinol braided mesh, stainless steel shaft, nitinol core wire and a handle.  Its proximal and distal ends are each fitted with a 90% platinum/10% iridium alloy developer marker. The Tigertriever Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA), or who fail IV t-PA therapy, are candidates for treatment.

In addition, animal studies were conducted to ensure the feasibility and safety of the product’s use. The results also showed that the product met the intended design requirements. The product is expected to increase the rate of postoperative revascularization and improve the quality of life of patients with acute ischemic stroke.

With the successful registration of this groundbreaking product, the medical community is eagerly awaiting its contribution to the field of intracranial therapy, not only for the successful treatment of patients.

In light of the approval, the regulatory authority for medical products remains committed to robust post-market supervision of the Tigertriever Revascularization Device. The goal is to ensure stringent safety standards are upheld, safeguarding patients during the device’s usage.

Meanwhile, Tigertriever Revascularization Device used overseas clinical trial as clinical evaluation in China. The clinical trial was conducted overseas and was designed as a multicenter, single-arm, prospective study design with 160 subjects.

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