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ADVANCED PERFORMANCE. EARLY RESORPTION. LONG-TERM DESOLVE SAFETY*. *Leverages DESolve NX 4Y safety data, A. Abizaid, TCT 2016. 120 µm

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Page 1: ADVANCED PERFORMANCE. EARLY RESORPTION. LONG-TERM … · Elixir Medical Corporate Headquarters 920 N McCarthy Blvd, Milpitas, CA 95035 USA 408.636.2000 | info@elixirmedical.com Elixir

A D V A N C E D P E R F O R M A N C E .

E A R LY R E S O R P T I O N. L O N G - T E R M D E S O L V E S A F E T Y*.

*Leverages DESolve NX 4Y safety data, A. Abizaid, TCT 2016.

120 µm

Page 2: ADVANCED PERFORMANCE. EARLY RESORPTION. LONG-TERM … · Elixir Medical Corporate Headquarters 920 N McCarthy Blvd, Milpitas, CA 95035 USA 408.636.2000 | info@elixirmedical.com Elixir

A NEW PE RFORMANC E STANDARD FOR BRS

INTRODUC ING TR ANSFOR MTM BALLOON TEC HNOLOGY

Designed to:

• Enhance scaffold expansion in the most resistant segment of the lesion

• Minimize edge dissection during deployment

• Optimize concentric expansion

1 Reduced 120 µm strut thickness

2 Improved deliverability1

3 Leverages DESolve platform

IMPROVE D DE LIVE R ABILIT Y1

While maintaining the DESolve’s unique

polymer characteristics, DESolve Cx

PLUS advances acute performance of

bioresorbable scaffolds.

TRACK FORCE

0 .20 .40 .60 .80 1.00 1.20

27% MOREDELIVERABLE

M E TA LLI C D E S

1. Data on file at Elixir Medical

Page 3: ADVANCED PERFORMANCE. EARLY RESORPTION. LONG-TERM … · Elixir Medical Corporate Headquarters 920 N McCarthy Blvd, Milpitas, CA 95035 USA 408.636.2000 | info@elixirmedical.com Elixir

The DESolve polymer is uniquely engineered to degrade in 6 months with near complete resorption at 1 year1 This timely combination of degradation and resorption allows

for early lumen and scaffold growth at 6 months.2

Furthermore, DESolve unique degradation and resorption

profile potentially addresses late and very late scaffold events

that may relate to the persistent presence of the scaffold/

polymer3 in other polymeric scaffolds which take 3-5 years to

resorb.4,5

At 4 years, the DESolve Nx study shows excellent safety with

no late or very late definite scaffold thrombosis.6

LE VE R AGES THE DESOLVE PL ATFORM

1. ~70% resorption in developmental preclinical data2. Abizaid A, et al. Serial Multimodality Imaging and 2-Year Clinical Outcomes of the Novel DESolve Novolimus-Eluting Bioresorbable Coronary Scaffold System for the Treatment of Single De Novo Coronary

Lesions. JACC Cardiovasc Interv. 2016;9:565-74.3. Yamaji, K, Raeber.L, Windecker S. What Determines long-term outcomes using fully bioresorbable scaffolds – the device, the operator or the lesion. Eurointervention 20 Feb 2017, vol 12:144. Rippy M., Vascular safety of Bioresorbable scaffolds made from biomaterials designed for use in interventional cardiology, EuroPCR 20145. Otsuka, et al, Long-term safety of an everolimus eluting bioresorbable vascular scaffold and the cobalt-chromium XIENCE V stent in a porcine coronary artery model, .Circ Cardiovasc Interv. 2014;7:330-3426. Abizaid A. Prospective, Multi-Center Evaluation of the DESolve Novolimus-Eluting Bioresorbable Coronary Scaffold: Imaging Outcomes and Four year clinical and imaging results. 10.31.16, TCT 2016.7. Does not correct for under-deployment.

SUSTAINE D SAFE T Y THROUGH 4 YE ARS

Definite Scaffold ThrombosisDESolve Nx (n=125)

3 Years 4 Years

Acute (0-1 day) 0 0

Sub Acute (2-30 days) 0 0

Late (31-365 days) 0 0

Very Late (>365 days) 0 0

Total 0 (0%) 0 (0%)

3 Year OCT

UNIQUE SE LF - CORREC TION DESIGNE D TO RE DUC E M AL APPOSITION & PRE VE NT C HRONIC RECOIL 7

OCT Immediately After Post-Dil

Scaffold Area: 7.71mm2

Scaffold Area: 8.01mm2

Scaffold Area: 8.49mm2

Scaffold Area: 8.51mm2

OCT 10 Minutes Later

Courtesy of A. Abizaid, Dante Pazzanese, Sao Paulo, Brazil

Prox Marker

Distal Marker

Mal apposed strut

Mal apposed strut

Page 4: ADVANCED PERFORMANCE. EARLY RESORPTION. LONG-TERM … · Elixir Medical Corporate Headquarters 920 N McCarthy Blvd, Milpitas, CA 95035 USA 408.636.2000 | info@elixirmedical.com Elixir

Scaffold Diameter (mm)

Scaffold Length (mm)

14 18 23 28

2.5 BFR2514 BFR2518 BFR2523 BFR2528

3.0 BFR3014 BFR3018 BFR3023 BFR3028

3.5 BFR3514 BFR3518 BFR3523 BFR3528

DESOLVE CX PLUS ORDERING INFORMATION

INTERNATIONAL (OUS) USE ONLY Caution: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device.

Elixir, Innovation for Life, and DESolve are US and internationally registered trademarks of Elixir. ©2017 Elixir 04/30

DESolve CX PLUS is CE Mark approved; All sizes may not be available in all geographies.

Elixir Medical Corporate Headquarters920 N McCarthy Blvd, Milpitas, CA 95035 USA

408.636.2000 | [email protected] LIXIR ME DICAL .com

Elixir Medical Corporation specializes in developing products that combine state-of-the-art medical devices with advanced pharmaceuticals to provide innovative treatment solutions to patients worldwide.

TR ANSFOR MTM BALLOON TEC HNOLOGY

3mm3mm

ɸAɸA ɸA + 0.25mm

Balloon central segment expands to 0.25mm larger than the end segments at nominal pressure

3mm length segments on proximal and distal ends expand to nominal diameter

Smooth dome-shaped transition

Single balloon material

Porcine Study 2030-029N – D90-10 – RCA Mid

428 Rev A