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Europe, Middle East, Africa / Product Areas / Interventional Cardiology & Radiology / Coronary Interventions / Freesolve

Freesolve^™ RMS

Metallic performance^1-3. Fully resorbable^*4

Indicated for de novo coronary artery lesions^a

Support
Resorbable coronary scaffolds widen coronary artery stenoses and provide temporary vessel support. Thereby, scaffolds enable unobstructed blood flow in the coronary arteries with low rates of stent thrombosis (ST) and target lesion revascularization (TLR).

Resorb
By degrading after fulfilling their scaffolding function, they offer all options of future therapies.

Product Highlights

Delivers like a DES⁵

Optimal vessel support^6,7

Magnesium fully resorbed after 12 months⁸

Excellent safety and efficacy^2,3

Delivers like a DES⁵

Push⁵
Better than contemporary DES

Track⁵
Better than contemporary DES

Optimal vessel support^6,7

Predictable, homogeneous resorption process⁶

Equal resorption between struts⁶

Uniform shape due to homogeneous strut resorption⁶

More than 3 months vessel support^6,7

Magnesium fully resorbed after 12 months⁸

>99% of struts no longer visible at 12 months⁸

Excellent safety and efficacy^2,3

The in-scaffold Late Lumen Loss (LLL) for Freesolve^™ RMS is on the level of a contemporary DES¹⁰

Freesolve^™ RMS Median LLL: 0.19 mm³

Contemp. DES Median LLL: 0.18 mm¹⁰

36-month outcomes confirms, Freesolve RMS^™ delivers on its promise¹²

Clinical Highlights

BIOMAG^™-I

In-Scaffold Late Lumen Loss (LLL) for Freesolve RMS is on the level of a contemporary DES.
The prospective BIOMAG^™-I clinical trial assesses the angiogrpahic, clinical and safety performance of DREAMS 3G RMS of 116 patients with single de novo lesions up to two coronary arteries.

Product Overview

Scaffold
Scaffold material	Proprietary BIOmag™ Magnesium alloy
Strut thickness	ø 2.5 mm: 99 μm; ø 3.0/3.5 mm: 117 μm; ø 4.0 mm: 147 μm
Maximum expandable diameter	Nominal diameter + 0.6 mm
Markers	One oval Tantalum marker at each end
Drug coating	BIOlute™ resorbable Poly-L-Lactide (PLLA) eluting a limus drug

Delivery system
Catheter type	Rapid exchange
Catheter length	140 cm
Recommended guide catheter	6F
Crossing profile	ø 2.5 mm ≤ 1.3 mm; ø 3.0–4.0 mm ≤ 1.4 mm
Guide wire diameter	0.014”
Nominal pressure (NP)	10 atm
Rated burst pressure (RBP)	16 atm

Scaffold ø (mm) (SD)	Recommended ø (mm) (RVD)
2.50	2.50 – 2.70
3.00	2.70 – 3.20
3.50	3.20 – 3.70
4.00	3.70 – 4.20

		Balloon diameter (mm)
		ø 2.50	ø 3.00	ø 3.50
Nominal Pressure (NP)	atm** ø (mm)	10 2.52	10 3.04	10 3.54
Rated Burst Pressure (RBP)	atm** ø (mm)	16 2.72	16 3.29	16 3.79
*1 atm = 1.013 bar

Scaffold ø (mm)	Scaffold length (mm)
	13	18	22	26	30
2.50	443103	443104	443105	-	-
3.00	443108	443109	443110	482156	443111
3.50	443113	443114	443115	482157	443116
4.00	443118	443119	443120	482158	443121

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:

RMS (Resorbable Magnesium Scaffold). Target Lesion Failure (TLF) is a composite of Target-Vessel Myocardial Infarction (TV-MI), clinically-driven Target Lesion Revascularization (CD-TLR) and Cardiac Death. *99.3% resorbed at 12 months (markers are not resorbable), based on clinical data; **based on QCA paired data. a. Indications as per IFU; b. BIOMAG-I case in normal cine projection, courtesy of Prof. Michael Haude, Rheinland Klinikum Neuss GmbH, Lukaskrankenhaus, Neuss, Germany; c. Xience Sierra DES (Abbott); d. Angiographic and OCT Analyses derived from two different BIOMAG-I cases, courtesy of Prof. Michael Haude, Rheinland Klinikum Neuss GmbH, Lukaskrankenhaus, Neuss, Germany; e. The 4P protocol was respected.

1. Data on file, benchtest data; 2. Haude M. et al., the Lancet eClinicalMedicine 2023;59: 101940; 3. Haude, M. et al., EuroIntervention 2023;19:1-1 published online May 2023; 4. Seguchi M et al. OCT-Analysis 12M, presented at ESC 2023; 5. Data on file, Benchtest data: Freesolve in comparison to Orsiro Mission and Abbott Xience Sierra; 6. Based on pre-clinical data, Seguchi, M. et al., EuroIntervention 2023;18-online publish-ahead-of-print January 2023; 7. Data on file, in comparison to predecessor device; 8. Based on intravascular OCT analysis of the BIOMAG-I trial presented by Dr. M. Seguchi at ESC 2023; 9. Data on file; 10. Byrne, RA. et al., Eur Heart J 2015;36:2608-2620; 11. Haude M., et al. Sustained safety and performance of the second-generation drug-eluting absorbable metal scaffold in patients with de novo coronary lesions: 12-month clinical results and angiographic findings of the BIOSOLVE-II first-in-man trial. Eur Heart J. 2016;37:2701-9; 12. Haude M. et al., Clinical outcomes of the third-generation resorbable magnesium scaffold for coronary artery lesions: three-year results of the BIOMAG-I study. EuroIntervention 2025;21:e1-e3.

BIOSOLVE-II and BIOMAG-I based on Kaplan-Meier failure estimate analysis.

Teleflex, the Teleflex logo, BIOlute, BIOmag, BIOMAG, Freesolve, Magmaris, Orsiro and Orsiro Mission are trademarks or registered trademarks of Teleflex Incorporated or its affiliates in the U.S and/or other countries. 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. All other names are the trademarks or registered trademarks of their respective owners. Information in this material is not a substitute for the product Instructions for Use. Not all products may be available in all countries.