PearlFlow

Paclitaxel Eluting Peripheral Drug Coated Balloon Dilatation Catheter

Pearl Flow :Peripheral Drug Coated Balloon		Specifications
USABLE LENGTH		138 cm
LENGTH OF GUIDE WIRE LUMEN		127 cm
MATERIAL	Balloon	Proprietary polyamide compound
	Distal shaft	Polyamide, multilayer tubing
	Proximal shaft	Stainless steel, PTFE coated
SHAFT SIZE	Proximal	1.9 F
SHAFT SIZE	Distal	2.8 F
BALLOON FOLDING		3-fold balloon
MARKER BANDS		Embedded Platinum / Iridium marker
TIP PROFILE		0.017″ (0.43 mm)
MAX. RECOMMENDED GUIDE WIRE		0.014″ (0.36 mm)
RECOMMENDED GUIDING CATHETER	min. ID	5 F / 0.056″ (1,65 mm)
Usable Catheter length		85cm / 150cm
Material	Balloon	Polyamide
	Shaft	Polyamide, Dual lumen tubing
X-ray marker		Platinum-Iridium
Catheter design		OTW – over the wire
Introducer set		4 F
Catheter		4 F catheter
Max. recommended guide wire		0.018″

Coating:

DRUG (API)	Paclitaxel
DOSAGE	3,0μg/mm2
TRANSFER MATRIX (Exipient)	Butyryl-tri-hexyl citrate (BTHC)
COATED AREA	Cylinder and tapered sections of the balloon

In peripheral artery disease, DCB therapy has proven superior to balloon angioplasty for treatment of de novo femoropopliteal and below-the-knee disease.

The Excipient

The excipient is a crucial part of a drug-eluting balloon, as it may have a direct effect on the drug uptake. The rationale behind a higher drug uptake lies in the effect of the excipient.

Another benefit of excipients may be the smooth dispersion of the drug in the excipient matrix increasing the uptake

Why Butyryl-tri-hexyl citrate (BTHC) coating?

Proven Track record
Keeps Paclitaxel in microcrystalline structure
Degrades to Citric acid and alcohol and metabolized rapidly.
BTHC coating is less soluble than hydrophilic alternatives resulting in more bio-availability of the drug

Balloon Compliance Chart:

		Balloon-Ø [mm] 4,00 5,00
		2.00	2.50	3.00	4.00	5.00	6.00	7.00
Pressure- [MPa/atm ]	0.7 / 7	2.00	2.50	3.00	4.00	5.00	6.00	7.00
	0.8 / 8	2.04	2.53	3.03	4.06	5.11	6.08	7.05
	0.9 / 9	2.09	2.57	3.05	4.12	5.22	6.15	7.10
	1.0 / 10	2.13	2.60	3.08	4.18	5.32	6.23	7.15
	1.1 / 11	2.18	2.63	3.10	4.24	5.43	6.30	7.20
	1.2 / 12	2.22	2.67	3.13	4.30	5.54	6.38	7.25
	1.3 / 13	2.27	2.70	3.15	4.36	5.65	6.45	7.30
	1.4 / 14	2.31	2.73	3.18	4.42	5.76	6.53
	1.5 / 15	2.35	2.77	3.20
	NOMINAL PRESSURE 0.7 MPa / 7 atm
	RBP (Rated Burst Pressure)

Ordering Information:PearlFlow (0.018″ Guide Wire / Shaft Length 85cm)

Balloon-Ø	Balloon Length
Balloon-Ø	40 mm	60 mm	80 mm	120 mm	150 mm
2.00 mm	PFM2000400 85	PFM2000600 85	PFM2000800 85	PFM20001200 85	PFM20001500 85
2.50 mm	PFM2500400 85	PFM2500600 85	PFM2500800 85	PFM25001200 85	PFM25001500 85
3.00 mm	PFM3000400 85	PFM3000600 85	PFM3000800 85	PFM30001200 85	PFM30001500 85
4.00 mm	PFM4000400 85	PFM4000600 85	PFM4000800 85	PFM40001200 85	PFM40001500 85
5.00 mm	PFM5000400 85	PFM5000600 85	PFM5000800 85	PFM50001200 85	PFM50001500 85
6.00 mm	PFM6000400 85	PFM6000600 85	PFM6000800 85	PFM60001200 85	PFM60001500 85
7.00 mm	PFM7000400 85	PFM7000600 85	PFM7000800 85	PFM70001200 85	PFM70001500 85

Ordering Information:PearlFlow (0.018″ Guide Wire / Shaft Length 150cm)

Balloon-Ø	Balloon Length
Balloon-Ø	40 mm	60 mm	80 mm	120 mm	150 mm
2.00 mm	PFM2000400 150	PFM2000600 150	PFM2000800 150	PFM20001200 150	PFM20001500 150
2.50 mm	PFM2500400 150	PFM2500600 150	PFM2500800 150	PFM25001200 150	PFM25001500 150
3.00 mm	PFM3000400 150	PFM3000600 150	PFM3000800 150	PFM30001200 150	PFM30001500 150
4.00 mm	PFM4000400 150	PFM4000600 150	PFM4000800 150	PFM40001200 150	PFM40001500 150
5.00 mm	PFM5000400 150	PFM5000600 150	PFM5000800 150	PFM50001200 150	PFM50001500 150
6.00 mm	PFM6000400 150	PFM6000600 150	PFM6000800 150	PFM60001200 150	PFM60001500 150
7.00 mm	PFM7000400 150	PFM7000600 150	PFM7000800 150	PFM70001200 150	PFM70001500 150

The Excipient

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