"Arblet Blood Pressure Calculation Program Alysis-001" with long-term blood pressure recording as its intended use and effect has been approved for manufacturing and sales, contributing to improving the quality of life of hypertension patients

Macnica [Headquarters: Kohoku-ku, Yokohama, Kanagawa Prefecture; Representative Director and President: Kazumasa Hara] (hereinafter referred to as Macnica), Arblet, Inc. [Headquarters: Shibuya-ku, Tokyo; President and Board Director: Hiromitsu Shimizu] (hereinafter referred to as Arblet), and Taisho Pharmaceutical Co., Ltd. [Headquarters: Toshima-ku, Tokyo; President and CEO: Shigeru Uehara] (hereinafter referred to as Taisho Pharmaceutical) are pleased to announce that on October 15, 2024, Arblet obtained manufacturing and sales approval for the "Arblet Blood Pressure Calculation Program Alysis-001 (generic name: Blood Pressure Recording Program)" (hereinafter referred to as this product) as a medical device program with the purpose or effect of "long-term (24 hours or more) recording of blood pressure." Currently, preparations are underway for a business alliance between Macnica, Arblet, and Taisho Pharmaceutical. We will provide further information on the release date, etc.

This product is a medical device program that uses a cuff^-less bracelet-type wearable device to display blood pressure values using a blood pressure calculation algorithm based on data obtained from light, potential, acceleration, and angular velocity sensors. It can monitor diurnal blood pressure fluctuations and sudden increases and decreases while the patient is moving about freely 24 hours a day, while reducing the physical and psychological burden on the patient. Ambulatory blood pressure is considered to be the blood pressure closest to daily life, and is useful for evaluating blood pressure variability, such as blood pressure fluctuations during sleep at night and under stressful conditions during the day, and morning surges, ^and is said to be more effective at predicting organ damage and the onset of cerebrovascular disease than office blood pressure. It is expected that 24-hour ambulatory blood pressure monitoring (ABPM) using this product will be used to manage high-risk patients with hypertension and detect masked hypertension, leading to the prevention of cerebrovascular disease.

Through the provision of this new blood pressure calculation program, Macnica, Arblet, and Taisho Pharmaceutical will work to improve the quality of life of hypertension patients by contributing to higher quality diagnosis and treatment of hypertension.

※Cuff:
A long, thin, bag-like cloth that is wrapped around the upper arm when measuring blood pressure. It can be inflated by pumping air into it to compress the blood vessels and regulate blood flow.

Morning Surge:
This refers to a transient rise in blood pressure that occurs in the early morning, just before or after waking up. The morning surge has a negative impact on cerebrovascular events.
It is believed that...

Approval Summary
Generic name: Blood pressure recording program (71128002)
Approval number: 30600BZX00212000
Product name: Arblet Blood Pressure Calculation Program Alysis-001
Classification: Controlled medical device (Class II)