REGENERATION trial. Clinical evaluation of the

new Relay PRO and

RELAY NBS PRO stent-grafts in TEVAR

Fabio Verzini, MD, PhD, FEBVS for The Re-Generation trial Participants

Prospective, multicentre, European investigational study to evaluate acute results (operative to 30-day) of the new Relay PRO Thoracic Endografts

Re-Generation Trial: definition

30 subjects

8 sites 3 to 5 subjects / site (estimated)

2 countries

1-month follow up

10 patients minimum will be treated with Relay PRO or Relay NBS PRO

Participating Sites

SPAIN: V. Riambau (P.I.) ! Hospital Clinic Barcelona I. García ! Hospital M. Valdecilla (Santander) S. Llagostera / C. Esteban ! Hosp. G. Trias (Badalona) J. Maeso ! Hospital Vall Hebrón (Barcelona)

ITALY: R. Giudice ! Ospedale San Giovanni Roma G. Fadda ! Ospedale S. Francesco, Nuoro P. Trabattoni ! Centro Cardiologico Monzino (Milano) M. Lenti / F. Verzini ! Az. Ospedaliera & University of Perugia

Primary Endpoints •  Freedom from Aortic-related mortality •  Delivery and deployment success evaluation:

o  Delivery system evaluation o  Overall rate of vascular access complications (≤30 days) o  Rate of access failures o  Rate of deployment system difficulties

Secondary Endpoint •  Freedom from major device-related adverse events [endoleak

(Types I, III and IV), stent migration (> 10mm as compared to the 1 month visit), lumen occlusion, aorta rupture, deployment failure, and conversion to surgical repair at 30 days

Inclusion / Esclusion Criteria ! According to the IFU of current RELAY plus and RELAY NBS plus

Stent Graft improvements

Delivery device improvements

Reduction of 3 to 4 F for each diameter

17

18

19

20

21

22

23

24

25

26

27

22 24 26 28 30 32 34 36 38 40 42 44 46

Fren

ch s

ize

(OD

)

New Profile distribution

Material improvements contributing to profile reduction

Engineered Graft Material

Graft fabric will change to an engineered textile to reduce profile

Delivering 47% profile reduction

Optimized Radiopaque

Markers position

Improved Primary Sheath

design

Reviewed Secondary Sheath

material

Thin wall coiled primary introducer sheath

Delivering 11% profile reduction

Reduction of secondary sheath diameter:

"  Relay Pro: 9.0mm

and wall thickness: "  Relay Pro: 0.0025”

Delivering 28% profile reduction

Profile reduction

PATIENT POPULATION N %

Gender distribution

Male 18 78

Female 5 22

TOTAL

23 100.0

Age at operation (years) Mean (range) 7.8 (39 - 86)

Clinical results

THORACIC AORTA LESIONS TREATED

N % Atherosclerotic aneurysm 19 84 Chronic 17 Ruptured 1 TAA + PAU 1

N % Dissection 4 10.5 TAD + PAU

2

Not reported

1 5.5

Lesion diameter (mean) 56.0 mm

Clinical results

OPERATIVE DATA N %

Number of stents used

1 device 17 73.9

2 devices 5 21.7

3 devices 1 4.4

Total stents used 30

Relay PRO vs. Relay NBS PRO

12/18 40/60

Mean units/patient 1.3 OPERATIVE DATA

N %

Intended Landing zone Z0 1 4.3 Z1 2 8.8 Z2 5 21.7 Z3 5 21.7 Z4 10 43.5

Aortic arch 56.5%

OPERATIVE DATA

Mean access diameter (mm)

8.8

Induced hypotension

16 (69%)

Technical success

22 (95.6%)

Complications 3* (13.0%)

* 1 Endoleak Type I a + Device did not deploy at the target zone (hypotension not used) 1 Stroke (unlikely device-related. Previous debranching of SAT) 1 Stent-graft migration during deployment (windsock effect)

Clinical results

OUTCOMES AT DISCHARGE

Hospital stay (days) Mean (range) 4.0 (1 - 13) ICU stay (hours) Mean (range) 18.8 (0-104)

N % Mortality Early (≤30 days) or operative deaths 0 0

Clinical results

FU DATA (n = 16)

Normal findings

15

Abnormal findings

1 Small Type Ia endoleak

Conversion to Open Surgery

0

SAEs

1 SAE (Stroke)

Clinical results

Case 1

Preoperative Post operative

Case 2

Preoperative Post operative

Conclusions

# Relay PRO and Relay NBS PRO represent the newest improvements in Relay family products

# Refinements have been designed both in the delivery device and in the stent-graft

# Clinical evaluation is close to be completed by REGENERATION European trial

#  Product is expected to be available before the end this year

# Clinical results demonstrate the high performance of the product in regards navigability, accuracy, conformability and safety

# REGENERATION trial confirms that the new Relay PRO and Relay NBS PRO are leading edge all-round devices in TEVAR

18

Thank you

REGENERATION trial. Clinical evaluation of the

new Relay PRO and

RELAY NBS PRO stent-grafts in TEVAR

Fabio Verzini, MD, PhD, FEBVS for The Re-Generation trial Participants