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OCS™ Heart SystemDBD Indication Commercial Overview
2FOR INTERNAL USE ONLY - OCS™ Heart DBD Indication - REV 1
OCS Heart Solution Set Physiologic high nutrients and
adenosine rich solution
OCS Heart Console Compact, highly portable device that fits in all modes
of air and ground transportation of donor hearts
OCS Heart Perfusion Module
Sterile, biocompatible perfusion circuit with embedded
hemodynamic sensors
The TransMedics Organ Care System (OCS™) Heart Technology
The TransMedics OCS Heart System is an integrated portable perfusion platform designed to overcome limitations of cold storage preservation.
OCS Heart Monitor Bluetooth tablet for
hemodynamic monitoring and control of the OCS perfusion
3FOR INTERNAL USE ONLY - OCS™ Heart DBD Indication - REV 1
The OCS™ Heart System is now FDA approved and is indicated for the preservation of DBD donor hearts deemed unsuitable for procurement and transplantation at initial evaluation due to limitations of prolonged cold static cardioplegic preservation (e.g., > 4 hours of cross-clamp time). This indication is based on the results of the OCS Heart EXPAND Trial and the associated OCS Heart EXPAND Continued Access Protocol (CAP).
The Only FDA Approved Extracorporeal Perfusion System for Heart Preservation
Donor Characteristics EXPAND + CAP(N=138)
UNOS/SRTR*(N=10,873) p-value
Age (years) – mean ± SD 36.4 ± 12.1 32.1 ± 11.0 < 0.0001
Age ≥ 55 years 13 (9%) 309 (3%) 0.0002
LVH >12 ≤ 16mm 18 (19%) Not collected
Cross-clamp time ≥ 4 hours (Actual) 113 (97%) 1730 (16%) < 0.0001
LVEF between 40% - 50% 30 (22%) 500 (5%) < 0.0001
Downtime ≥ 20 minutes 43 (31%) 255 (2%) < 0.0001
Cross-clamp time ≥ 4 hours plus ≥1 risk factor 23 (17%) 500 (5%) < 0.0001
Downtime ≥ 20 minutes plus ≥ 1 risk factor 10 (7%) 61 (1%) < 0.0001
* Data from 2015-2018 US Heart Transplant Registry on DBD Heart Transplants using cold storage preservation
OCS Heart EXPAND & CAP Enrolled Donor Hearts that are Seldom used for Transplants in the U.S. Compared to the UNOS Transplant Database
Type of Donor Hearts Suitable for OCS Heart SystemTypes of DBD donor hearts that were successfully transplanted after OCS heart perfusion in the Heart EXPAND Trial included:
Long cross-clamp time
≥4 hours (due to donor or
recipient logistics)
Donor with ≥20 mins
down time
Older donors
Donor LVEF 40-50%
Combination of any of the listed criteria
Donor with LVH
≤ 16mm
4FOR INTERNAL USE ONLY - OCS™ Heart DBD Indication - REV 1
In addition, EXPAND and CAP enrolled donor hearts with a high UNOS donor match run refusals (60 refusals on average). Median match run refusals was 22 vs. 2 reported in UNOS database.
40
EXPAND + CAP (N=138)
30
20
10
0
50
Mean ± Cl60
70
DONOR HEART UNOS MATCH RUN REFUSALS (Prior to OCS Heart Perfusion & Assessment)
40
EXPAND + CAP (N=138)
30
20
10
0
22Number of UNOS Match Run Refusals
Median ± Cl
UNOS Data* 2007-2014
2
* Baran et al, Circ Heart Fail 2019
60
The use of OCS Heart System in EXPAND and CAP Trials resulted in 84% donor heart utilization for transplantation from these types of DBD donors. OCS Heart Lactate profile was a critical factor to enable the assessment of these donor hearts for transplantation.
OCS Heart resulted in high rate of utilization of these DBD Donor Hearts
84%
16%(22 /138)
Turned Down
Transplanted after OCS Perfusion
OCS UTILIZATION
7
6
5
4
3
2
1
0
OCS Heart lactate profile enabled assessment of turned down hearts
OCS ASSESSMENT
0 0.5 1 1.5 2 2.5 3 3.5 4 4.5 5
Turned Down Hearts (n=22)
Transplanted Hearts (n=116)
Hours after instrumentation on OCS
Mea
n A
rter
ial L
acta
te (m
mol
/L) [
SE]
5FOR INTERNAL USE ONLY - OCS™ Heart DBD Indication - REV 1 5FOR INTERNAL USE ONLY - OCS™ Heart DBD Indication - REV
Excellent Clinical Outcomes from Expanded Criteria Donor Hearts
10
LV or RV Severe PGD
5
0
15
8%
Incidence of Post-Transplant PGD
Inci
denc
e %
20
LV or RV Moderate or Severe PGD
15%
Surv
ival
Pro
bab
ility
Month 0 1M 2M 3M 4M 5M 6M 12M
Overall 116 111 100 98 97 96 85 65
Cardiac-related 116 111 100 98 97 96 85 65
Months Post-Transplant
Follow-up Overall Cardiac-related
Month 1 97% 97%
Month 2 96% 97%
Month 3 94% 96%
Month 4 93% 96%
Month 5 92% 96%
Month 6 92% 96%
Month 12 87% 96%
0.2
0 3 6 9 12
0.4
0.6
0.8
1 Cardiac-related Survival
Overall Survival
Clinical & Economic Value of the OCS™ Heart System to your Transplant Program
GoodClinical
Outcomes
Increase Transplant
VolumeImprove Financial
Performance
TransMedics, Inc.200 Minuteman Rd, Ste. 302Andover, MA 01810
TransMedics® and OCS™ are trademarks of TransMedics, Inc. ©2021 TransMedics, Inc. All rights reserved. All other trademarks are the property of their respective owners.
For more information on a heart transplant with the OCS Heart System, please contact TransMedics, Inc. by mail, by phone, or online as shown below.
MAIL: TransMedics, Inc. 200 Minuteman Road, Suite 302 Andover, MA 01810
PHONE: US: 978.552.0900
ONLINE: www.transmedics.com
CONTACT INFORMATION
