SCIENTECH (02291.HK): MemoCarna PFO occluder wins device certificate

On 12 October 2026, SCIENTECH (02291.HK) said its MemoCarna oxide-film single-rivet PFO occluder obtained a China medical device registration certificate.
Key Highlights:
  • Patent foramen ovale is usually asymptomatic, with unexplained stroke and migraine most common, and is a major cause of cryptogenic stroke.
  • Public studies put the incidence of residual shunt after PFO closure at about 10% to 30%, linked to a higher risk of stroke recurrence.

NewTimeSpace News: On 12 October 2026, LEPU ScienTech Medical Technology (Shanghai) Co., Ltd. (stock code: 02291.HK) said its wholly-owned subsidiary Shanghai Shape Memory Alloy Material Co., Ltd. has obtained a medical device registration certificate from China's National Medical Products Administration for the MemoCarna® oxide-film single-rivet PFO occluder.

Patent foramen ovale (PFO) is usually asymptomatic, but a severe defect can cause unexplained stroke and migraine and is a major cause of cryptogenic stroke. Transcatheter closure is a key treatment, yet residual shunt remains an issue, with public studies putting incidence at 10% to 30%. The self-developed product features an "M+W" interlocking, single-rivet recessed disc design, a concealed waist structure and a three-layer flow-blocking membrane, and comes in nine specifications. Together with its registered MemoSorb® bioresorbable PFO occluder, this approval enriches the Company's portfolio. 

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