Next generation of Balloon Guide Catheter

	STRAIT Clinical Data	Highest value per literature	Lowest value per literature
mTICI 2B-3	95%	STRATIS Registry³ 89%	Jeong et al.⁴ 84%
mTICI 2C-3	75.9%	STRATIS Registry³ 65%	Brinjiki et al.⁵ 58%
First Pass Effect	63%	MR CLEAN Registry Substudy⁶ 50%	Jeong et al.⁷ 40%
mRS 0-2	95.2%	Nguyen et al.⁸ 58%	Jeong et al.⁹ 53%
Procedure Time	N/A	Nguyen et al.⁸ 32 min	MR CLEAN Registry Substudy⁶ 40 min
Puncture to Reperfusion Time	48.7%	N/A
Time from BGC Insertion	8.8 min	N/A
Time from BGC Insertion to Inflation	21.9 MIN	N/A
Hemorrhage (sICH)	0%	MR CLEAN Registry Subgroup⁶ 5.0%	Nguyen et al.⁸ 2.9%
Mortality	8.5%	MR CLEAN Registry Subgroup⁶ 28.0%	Jeong et al.⁹ 12.0%
Embolization to New Territories (ENT)	6.0%	STRATIS Registry⁶ 5.2%	Jeong et al.⁹ 3.2%

1. Data on file, Terumo Neuro
2. P116 The new generation BOBBY balloon guide catheter for mechanical thrombectomies: results of the international prospective STRAIT study | Journal of NeuroInterventional Surgery https://jnis.bmj.com/content/16/Suppl_2/A97.1
3. Impact of Balloon Guide Catheter Use on Clinical and Angiographic Outcomes in the STRATIS Stroke Thrombectomy Registry - Osama O. Zaidat, et al. – Stroke
4. Clinical Impact of Balloon Guide Catheter in Mechanical Thrombectomy for Large Vessel Occlusion Stroke - Dae-Eun Jeong, et al. - American Journal of Neuroradiology (AJNR) – 2019
5. Impact of Balloon Guide Catheters on Technical and Clinical Outcomes: A Systematic Review and Meta-Analysis - Waleed Brinjikji, et al. - Journal of NeuroInterventional Surgery (JNIS) – 2018
6. Balloon Guide Catheter Versus Non–Balloon Guide Catheter: A MR CLEAN Registry Substudy - Robrecht R.M.M. Knapen, René van den Berg, et al. - Stroke: Vascular and Interventional Neurology – 2021
7. Clinical Impact of Balloon Guide Catheter in Mechanical Thrombectomy for Large Vessel Occlusion Stroke - Dae-Eun Jeong, et al. - American Journal of Neuroradiology (AJNR) – 2019
8. Balloon Guide Catheter Improves Revascularization and Clinical Outcomes with the Solitaire Device: Analysis of the North American Solitaire Acute Stroke Registry - Thanh N. Nguyen, et al. – Stroke – 2014
9. Clinical Impact of Balloon Guide Catheter in Mechanical Thrombectomy for Large Vessel Occlusion Stroke - Dae-Eun Jeong, et al. - American Journal of Neuroradiology (AJNR) - 2019

Intended Purpose: The BOBBY Balloon Guide Catheter is intended for use in facilitating the insertion and guidance of an intra vascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for retrieval devices. Legal Manufacturer: MicroVention, Inc. / EU Authorized Representative: MicroVention Europe SARL.
The SOFIA Catheter is indicated for general intra vascular use, including the neuro and peripheral vasculature. The SOFIA Catheter can be used to facilitate the introduction of diagnostic or therapeutic agents. The SOFIA Catheter is not intended for use in coronary arteries. Moreover, the SOFIA Catheter is intended for use in the removal/ aspiration of emboli and thrombi from selected blood vessels in the arterial system, including the peripheral and neurovasculatures. Legal Manufacturer: MicroVention Europe SARL.

Please refer to IFU for the full list of risks, contraindications, warnings, and precautions.

For Healthcare Professionals Use Only

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