Cardiovascular Systems

Cardiovascular Systems (CSI) is a medical device brand whose product line, as presented on its CSI360 website, includes the Diamondback 360 and Stealth 360 Peripheral Orbital Atherectomy Systems (OAS), the Diamondback 360 Coronary OAS, ViperWire Advance Peripheral Guide Wire, ViperCross Support Catheter, Shepherd Peripheral Guidewire, ViperSlide Lubricant, and ViperCath XC Peripheral Exchange Catheter. The site provides instructions for use (IFUs) for these products, including international IFUs for Canada, and references clinical study summaries such as OASIS and ORBIT II.

The CSI360 website presents Cardiovascular Systems' instructions for use (IFUs) for its peripheral and coronary orbital atherectomy systems and related accessories. Listed products include the Diamondback 360 Peripheral OAS, Stealth 360 Peripheral OAS, Diamondback 360 Coronary OAS, ViperWire Advance Peripheral Guide Wire, ViperCross Support Catheter, Shepherd Peripheral Guidewire, ViperSlide Lubricant, and ViperCath XC Peripheral Exchange Catheter. The site also provides international IFUs for Canada and references clinical study summaries including OASIS and ORBIT II.

• Diamondback 360 Peripheral Orbital Atherectomy System (OAS)

  Peripheral orbital atherectomy system listed on the CSI360 instructions-for-use page.

• Stealth 360 Peripheral Orbital Atherectomy System (OAS)

  Peripheral orbital atherectomy system listed on the CSI360 instructions-for-use page.

• Diamondback 360 Coronary Orbital Atherectomy System (OAS)

  Coronary orbital atherectomy system listed on the CSI360 instructions-for-use page.

• ViperWire Advance Peripheral Guide Wire

  Peripheral guide wire listed on the CSI360 instructions-for-use page.

• ViperCross Support Catheter

  Support catheter listed on the CSI360 instructions-for-use page.

• Shepherd Peripheral Guidewire

  Peripheral guidewire listed on the CSI360 instructions-for-use page.

• ViperSlide Lubricant

  Lubricant listed on the CSI360 instructions-for-use page.

• ViperCath XC Peripheral Exchange Catheter

  Peripheral exchange catheter listed on the CSI360 instructions-for-use page.

• 2021

  Cardiovascular Systems recalls Wirion device

  Cardiovascular Systems Inc. initiated a U.S. recall of its Wirion atherectomy embolic protection device after reports of filter breakage during retrieval; the FDA identified it as a Class I recall.

  Source

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• 2021-11-22

  Cardiovascular Systems recalls Wirion device[3]Cardiovascular Systems recalls Wirion devicedicardiology.com

  Cardiovascular Systems Inc. initiated a U.S. recall of its Wirion atherectomy embolic protection device after reports of filter breakage during retrieval; the FDA identified it as a Class I recall.

• 2019-12-16

  Cardiovascular Systems introduces 1.25 Micro Crown in Germany[4]Cardiovascular Systems 在德国推出 1.25 Micro Crownvascularnews.com

  Reported: 2019-12-16

  Cardiovascular Systems said it was introducing its Stealth OAS 1.25 Micro Crown with GlideAssist in Germany; the article also reports that the first patient in Europe had been treated with the system.

• Unconfirmed

  FDA approves ViperWire Advance with Flex Tip[5]FDA 批准 ViperWire Advance with Flex Tipdicardiology.com

  Cardiovascular Systems Inc. announced that the U.S. Food and Drug Administration had granted premarket approval for its ViperWire Advance Coronary Guide Wire with Flex Tip.

1. 1Instructions for Use | CSI360csi360.com
2. 2California Proposition 65 | CSI360csi360.com
3. 3Cardiovascular Systems recalls Wirion devicedicardiology.com
4. 4Cardiovascular Systems 在德国推出 1.25 Micro Crownvascularnews.com
5. 5FDA 批准 ViperWire Advance with Flex Tipdicardiology.com