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ALPINION Medical Systems receives CE mark for ALPIUS 900 ultrasound-guided HIFU

Press releases may be edited for formatting or style | February 19, 2016
SEOUL, KOREA—(17 Feb. 2016. BUSINESS WIRE)—ALPINION Medical Systems, Inc. has announced that its ALPIUS 900 has received CE Marking on 12 Feb 2016, and can now be sold in Europe as the advanced ultrasound guided HIFU (High Intensity Focused Ultrasound) system for the treatment of uterine fibroids.

ALPIUS 900 was approved by the MFDS (Ministry of Food and Drug Safety, KOREA) in 2014. ALPINION Medical Systems devoted three years to developing the HIFU system for uterine fibroids treatment and conducted the MFDS clinical trial with Seoul National University Hospital.

“ALPIUS 900 is the first Korean HIFU system, and it is developed and manufactured by ALPINION’s exclusive and patented technologies. ALPIUS 900 allows safer and more precise HIFU treatment of uterine fibroids while minimizing the occurrence of side-effects. European regulatory approval of ALPIUS 900 now makes it possible to bring ALPIUS 900’s advanced technologies to European gynecologists and/or physicians as well as patients in need.” said Keonho Son, Director of the Therapeutic Ultrasound Division in ALPINION Medical Systems.

- ALPIUS 900 provides innovative water-cooling technology to prevent patients’ skin burning. And its pre-targeting tool allows pre-checking of the focal point on the target before starting treatment, which increases treatment accuracy and patient safety.

- ALPIUS 900 has a multi-channel transducer, the latest generation of ultrasound transducers, which enables the ultrasound beam steering electronically. Thanks to this beam steering technology and ALPIUS 900’s intuitive workflow, on average 1 hour is enough to treat uterine fibroids so physicians can reduce the time spent on each treatment.

- One other remarkable strength of ALPIUS 900 is its compact, all-in-one design. All the devices needed for a HIFU treatment, such as an ultrasound imaging/monitoring system, transducer, and operating system, are built in to the ALPIUS 900. So there’s no need to attach any extra devices. With its outstandingly compact and portable design, ALPIUS 900 fits easily into any existing small room in a hospital.

“The results of the clinical trials at Seoul National University Hospital have shown that ALPIUS 900 is effective in the treatment of uterine fibroids and decreases pain from symptoms. As a non-invasive and radiation-free technology, HIFU treatment allows gynecologists to use a great option to treat uterine fibroids and to preserve the quality of women’s lives, and this can now be done using ALPIUS 900.” added Mr. Son.

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