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July 15, 2018

CSI Signs International Distribution Agreement With OrbusNeich

July 16, 2018—Cardiovascular Systems, Inc (CSI) announced an exclusive international distribution agreement with OrbusNeich to sell CSI's coronary and peripheral orbital atherectomy systems (OAS) outside the United States and Japan. OrbusNeich manufactures and sells an extensive portfolio of coronary and peripheral products including stents, balloons, and microcatheters. The company operates 12 regional sales offices throughout the world and their products are currently sold in more than 60 countries.

CSI advised that it will focus its international efforts on physician training and education to support the expanded use of orbital atherectomy.

OrbusNeich stated that the company intends to introduce CSI’s orbital atherectomy systems in multiple countries in Europe and Southeast Asia in 2018, focusing initially on those countries that recognize FDA approvals in addition to European markets where CSI has CE Mark approval for its peripheral technology.

In January 2018, CSI announced that it was the exclusive United States distributor for OrbusNeich balloon products. CSI will offer a full line of semicompliant, noncompliant, and specialty balloons for both coronary and peripheral vascular procedures. OrbusNeich percutaneous coronary intervention balloons include the Sapphire II Pro. Currently, CSI offers both the 1.0- to 4.0-mm Sapphire II Pro and the 2.0- to 4.0-mm Sapphire NC Plus coronary balloons.

Additionally, CSI announced in November 2016 that Medikit, Co., Ltd. signed an exclusive distribution agreement to sell its coronary and peripheral OAS in Japan.

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July 16, 2018

FDA Approves Stryker's Surpass Streamline Flow Diverter to Treat Intracranial Aneurysms

July 16, 2018

FDA Approves Stryker's Surpass Streamline Flow Diverter to Treat Intracranial Aneurysms