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Email Europe, Middle East, Africa Regional Office

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Email Teleflex Medical

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South Africa Mail Address Teleflex Medical (Pty) Ltd. P.O. Box 6882, Greenstone, 1616
Email Teleflex Medical Ltd.

Europe, Middle East, Africa / Product Areas / Interventional Cardiology/Radiology / Coronary Interventions / Pantera Leo

Pantera^™ LEO NC Balloon Catheter

Non-Compliant High Pressure Balloon Catheter

Indicated for stent post-dilation and dilation of a coronary artery or bypass graft stenosis.^a

Product Highlights

Lowest compliance in class¹ avoiding dog-bone effect²

More controlled growth from NP to RBP than leading competitors^b,2

Precise dilation²

Extra short balloon shoulders reduce longitudinal balloon growth²

Enhanced crossability²

Patchwork coating for enhanced crossability²

Proximal Shaft
Design	Hypotube design
Diameter	2.0F
Shaft markers	92 cm and 102 cm from tip
Coating	Hydrophobic

Distal shaft
Guiding catheter	5F (min. I.D. 0.056”)
Guide wire diameter	0.014”
Lesion entry proﬁle	0.018”
Usable length	145 cm
Distal shaft length	34 cm
Balloon material	SCP (Semi Crystalline Polymer)
Balloon folding	3-fold
Balloon markers	Platinum-Iridium
Coating	Hydrophilic (end of balloon to guide wire exit port) Hydrophobic (balloon and tip)
Diameter	2.6F (ø 2.0 - 3.75 mm) 2.7F (ø 4.0 - 5.0 mm)

Balloon diameter x length (mm)
		ø 2.00 x 8-30	ø 2.25 x 8-30	ø 2.50 x 8-30	ø 2.75 x 8-30	ø 3.00 x 8-30	ø 3.25 x 8-30	ø 3.50 x 8-30	ø 3.75 x 8-30	ø 4.00 x 8-30	ø 4.50 x 8-30	ø 5.00 x 8-30
Nominal Pressure (NP)	atm*	14	14	14	14	14	14	14	14	14	14	14
Nominal Pressure (NP)	ø (mm)	2.00	2.25	2.50	2.75	3.00	3.25	3.50	3.75	4.00	4.50	5.00
Rated Burst Pressure (RBP)	atm*	20	20	20	20	20	20	20	20	20	18	18
Rated Burst Pressure (RBP)	ø (mm)	2.05	2.32	2.57	2.83	3.09	3.35	3.61	3.89	4.12	4.56	5.07
*1 atm= 1.013 bar

	Balloon ø (mm)	Catheter length 145 cm Balloon length (mm)
5F		8	12	15	20	30
	2	366991	367002	367013	367024	367035
	2.25	366992	367003	367014	367025	367036
	2.5	366993	367004	367015	367026	367037
	2.75	366994	367005	367016	367027	367038
	3	366995	367006	367017	367028	367039
	3.25	366996	367007	367018	367029	367040
	3.5	366997	367008	367019	367030	367041
	3.75	366998	367009	367020	367031	367042
	4	366999	367010	367021	367032	367043
	4.5	367000	367011	367022	367033	367044
	5	367001	367012	367023	367034	367045

IFU Link

Refer to this IFU link for a copy of the Instructions for Use and for a complete listing of the indications, contraindications, warnings and precautions.

References:

Indication as per IFU
NP-RBP growth for 3.0 diameters. Leading competitors have been selected based on the PTCA Balloon Catheter Revenue Market Shares US, 2016; (Source: Milennium Research Group Inc.). Latest NC balloons for each competitor.

When compared to main competitors, compliance curves 3.0 mm balloons, Data on file
Data on file

Teleflex, the Teleflex logo, and Pantera are trademarks or registered trademarks of Teleflex Incorporated or its affiliates in the U.S and/or other countries. All other names are the trademarks or registered trademarks of their respective owners. Refer to this IFU link for a copy of the Instructions for Use and for a complete listing of the indications, contraindications, warnings and precautions. Information in this material is not a substitute for the product Instructions for Use. Not all products may be available in all countries.
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