Medico’s Hirata announces that Flex type and Fitto type were added to EGoist®, a dedicated guide wire for stent grafts (Trade Name: MH心臓・中心循環系用ガイドワイヤ, Approval Number: 22500BZX00510000).

EGoist® Flex & Fitto Interventional Guide Wire features both softness and stiffness with Super Long Tapered Core which added trackability and flexibility to conventional supportability.

Medico’s Hirata announces the launch of Penumbra Inc. “LANTERN microcatheter" (Trade Name：Penumbra PX400 マイクロカテーテル, Approval Number 22400BZX00295000

LANTERN microcatheter, with improved visibility between tip markers, enables safer accessibility to the target site and proper coil maneuverability.

Its 0.025 inch inner diameter adapts to large volume embolic coils.

Medico’s Hirata announces the launch of “M・Jector needle Neo” (self-developed product, Trade Name：ディスポーザブル内視鏡局所注射針, Certification Number：222ADBZX00029000).

“M・Jector needle Neo” is a next-generation Endoscopic injection needle with an improved manipulation capability with one hand, which is achieved by adding an Auto Lock System to the spring function of the conventional “M・Jector needle”(self-developed product, Trade Name：ディスポーザブル内視鏡局所注射針, Certification Number：222ADBZX00029000).

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.