Medico’s Hirata announces the launch of Lombard Medical’s “IntelliFlex™LP Delivery System, a new delivery system for "AORFIX AAA stent graft system" (Trade Name：AORFIX AAAステントグラフトシステム, Approval Number 22600BZX00317000).

IntelliFlex™ LP Delivery System realizes lower profile than our conventional delivery system.

（With Y-Mec™ Deployment System, the fish mouth of AORFIX AAA stent graft is evenly expanded to support accurate positioning

Medico’s Hirata announces that the following product was added to “Fencer” (Trade Name：マイクロカテーテル2, Approval Number 21700BZZ00471000).

Catalog Number: FE1820M1-ST80G
　- Effective length: 80 cm
　- Catheter outer diameter: 2.6 Fr ➤ 2.0 Fr (proximal ➤ distal end)
　- Catheter inner diameter: 0.021 inch
　- Maximum guide wire: 0.018 inch
　- Tip shape: Straight

Medico’s Hirata announces the launch of Medi-Globe’s “8-Wire Nitinol Basket” (Trade Name: Medi-Globe結石除去用バスケットセット, Certification Number 224ADBZX00024000).

8-Wire Nitinol Basket, uniquely designed in 8-wire shape, displays strong deployment and shape retention capabilities. Its further improved rotation performance makes it easier to capture stones.

Medico’s Hirata has previously taken over the marketing rights of ALN Implants Chirurgicaux Limited liability company’s “ALN 下大静脈フィルター and ALN下大静脈フィルター回収器具キット(Trade Names)” (Marketing Approval Holder: Piolax Medical Devices, Inc.) from Toray Medical Co., Ltd. In addition, Medico’s Hirata today announces that we　will start providing the products as the designated marketing approval holder (DMAH) for ALN, who has obtained the regulatory approval under its name.

The products approved for Piolax Medical Device, Inc. currently on the market will be switched to those approved for ALN as the stock becomes unavailable.
This will not affect the specifications of the products but cause changes to the Approval numbers, Trade names, Product names, Catalog numbers.

[Products approved for ALN]
Approval Number
　22800BZI00007000
Trade Name
　Aln Vena Cavaフィルター
Product Name
　Aln Vena Cava Filter
　Aln Vena Cava Filter Extraction Kit
Catalog Number
　FJ.120096
　FF.010995
　FT.200001
　FT.200001/VS2

[Products approved for Piolax Medical Devices, Inc.]
Approval Number
　21800BZY10233000 (Filter)
　22100BZX00190000 (Extraction Kit)
Trade Name
　ALN下大静脈フィルター
　ALN下大静脈フィルター回収器具キット
Product Name
　Aln Vena Cava Filter
　Aln Vena Cava Filter Extraction Kit
Catalog Number
　ALN030-28J
　ALN060-28F
　ALN090-10
　ALN090-10A
　ALN090-20
　ALN090-20A

Medico’s Hirata announces the launch of LSO Medical’s “Endothermelaser™ 1470” (Trade Name：LSO1470レーザー, Approval Number 22700BZX00311000).

The EndothermelaserTM 1470 is a laser device for the treatment of varicose veins in the lower extremities developed by LSO Medical, a French company that designs and manufactures medical lasers as its area of specialty.
Endovenous laser ablation of varicose veins in the lower extremities with this device is a treatment to occlude the venous wall by shrinking it with the circumferential laser beam at a wavelength of 1470nm irradiated from the laser fiber which is percutaneously inserted in the saphenous vein.

In Japan, this is a relatively new treatment approved to be reimbursed in 2011, drawing attention these days as a less invasive procedure for treating varicose veins without major dissection.
The efficacy and safety of the Endothermelaser™ 1470 was assessed in a clinical trial with three Japanese centers participated in, and it can be used with a 5F sheath, which is thinner than that used with conventional products.

Medico’s Hirata announces that it has received regulatory approval of STARmed’s “VIVARF System” (Trade Name：RFA Lesion システム, Approval Number: 22700BZX00035000). The VIVARF System is a device for percutaneous puncture of the malignant tumors in the liver to necrotize it with radiofrequency ablation.
Medico’s Hirata provides the first adjustable electrodes (VIVARF electrode) in Japan in addition to the conventional fixed electrodes (as of Aug. 4, 2015).

- VIVARF System (VIVARF Generator, VIVARF Pump)
- VIVARF electrode (electrode, ground pads and pump connecting tubes)
- star RF electrode (electrode, ground pads and pump connecting tubes)
- Components (VIVARF Generator, VIVARF Pump, VIVARF Foot Switch Set, VIVARF Single Foot Switch, VIVARF Double Foot Switch)

Medico’s Hirata has renewed its product descriptions page. We hope that we can remain to be of service to you.

Medico’s Hirata announces that it has received regulatory approval of Lombard Medical’s “AORFIXTM AAA Stent Graft System” (Trade Name：AORFIX AAAステントグラフトシステム, Approval Number 22600BZX00317000).
AORFIXTM is an AAA stent graft recommended to be launched as soon as possible at the “20th Meeting to Discuss the Early Launch of Highly Demanded Medical Devices, etc.”
as a device usable for the highly angulated AAA anatomies, including aortic neck angulation beyond 60 degrees up to 90 degrees, which were not indicated for conventional stent grafts.

Medico’s Hirata announces the launch of three PTA balloon catheters for peripheral vascular intervention, “Bellona”, “Bellona OTW” and “DIVA” as follows:

- Bellona (Approval Number: 22200BZX00115A02)
- Bellona OTW (Approval Number: 22300BZX00146A02)
- DIVA (Approval Number: 22100BZX01012A03)

Following the previous transfer of Cook aortic intervention and endoscopy products on April 1, 2012, Medico’s Hirata is now to transfer the distribution and sales rights of Cook peripheral intervention and interventional radiology products, as of April 1, 2014.

Cook peripheral intervention and interventional radiology products will continue to be available through Medico’s Hirata until March 31, 2014. After April 1, however, all the Cook products sold by us so far will be handled by Cook Japan. We look forward to your kind understanding.

We would like to take this opportunity to express that your continued purchase of Cook products through us over the past years is sincerely appreciated. As this transfer will enable us to add more advanced and high-quality products to our portfolio, we will commit to positively provide more useful medical devices. Your continued and further patronage and assistance would be highly appreciated.