advanced performance. early resorption. long-term … · elixir medical corporate headquarters 920...
TRANSCRIPT
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
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
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
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