Portico with FlexNav TAVI System Clinical Performance

Outstanding TAVI
OUTCOMES

ADVANCED OUTCOMES WITH FLEXNAV

The FlexNav delivery system cohort of the Portico IDE study demonstrated the following outstanding outcomes^1,2:

ALL-CAUSE
MORTALITY

DISABLING
STROKE

AKI III

LIFE-THREATENING BLEEDING REQUIRING TRANSFUSION

MAJOR VASCULAR COMPLICATIONS*

*4% TAVI delivery system access-site related complications.

SAFETY EVENT RATE (30 DAYS)

Composite of all-cause mortality, disabling stroke, life-threatening bleeding requiring blood transfusion, acute kidney injury requiring dialysis, or major vascular complications.

*Data represents a non-randomized sample of high- or extreme-risk patients transfemorally implanted with a Portico valve using the FlexNav Delivery System between November 2018 and June 2019.
^†Data represents a subset of high- or extreme-risk patients implanted with an Evolut R, Evolut PRO, or Sapien 3 valve via a transfemoral or alternative access approach between September 2014 and October 2017. Patients were enrolled as part of a separate pivotal randomized study arm of the PORTICO IDE trial.

CLINICAL OUTCOMES IN CONTEXT

OUTCOMES WITH THE LATEST-GENERATION FLEXNAV DELIVERY SYSTEM ARE CONSISTENT WITH LEADING TAVI VALVES^1,2

	30-DAY COMPARISON
	PORTICO WITH FLEXNAV (N = 100)^*	EVOLUT R/PRO (N = 110)^†	SAPIEN 3 (N = 206)^†
All-Cause Mortality (%)	0	0.9	0
Disabling Stroke (%)	0	0.9	1.0
Life-Threatening Bleeding Requiring Transfusion (%)	4.0	4.5	3.4
Major Vascular Complications (%)	7.0	6.4	7.3
New Permanent Pacemaker (%)	14.6	18.9	5.4
AKI III (%)	0	0.9	0
Mean Gradient (mmHg)	6.7	7.3	11.8
Aortic Valve Area (cm²)	1.8	1.9	1.6
Moderate or Greater PVL (%)	6.5	4.0	1.6

THE ADVANTAGE OF EXPERIENCE

The IDE FlexNav cohort reflects early experience (on average, less than 5 implants) with FlexNav. The PORTICO I Post-Market Clinical Follow-Up Study demonstrates real-world PVL performance of the Portico valve comparable with other leading commercially available valves.

*Data represents a non-randomized sample of high- or extreme-risk patients transfemorally implanted with a Portico valve using the FlexNav Delivery System between November 2018 and June 2019.
^†Data represents a subset of high- or extreme-risk patients implanted with an Evolut R, Evolut PRO, or Sapien 3 valve via a transfemoral or alternative access approach between September 2014 and October 2017. Patients were enrolled as part of a separate pivotal randomized study arm of the PORTICO IDE trial.

THE HEMODYNAMIC EDGE

Consistent with other leading self-expanding valves, Echo Core Lab data demonstrated that Portico valve outperforms balloon-expanding valves, with single-digit mean gradients and larger AVAs.^1,2
SELF-EXPANDING VALVES. SINGLE-DIGIT GRADIENTS.^1,2

Intra-annular Portico valve compares favorably to the supra-annular Evolut R/PRO valve.

*Data represents a non-randomized sample of high- or extreme-risk patients transfemorally implanted with a Portico valve using the FlexNav Delivery System between November 2018 and June 2019.
^†Data represents a subset of high- or extreme-risk patients implanted with an Evolut R, Evolut PRO, or Sapien 3 valve via a transfemoral or alternative access approach between September 2014 and October 2017. Patients were enrolled as part of a separate pivotal randomized study arm of the PORTICO IDE trial.
OUTPERFORMING BALLOON-EXPANDABLE VALVES^1,2

Intra-annular Portico valve offers excellent hemodynamics compared to intra-annular Sapien 3 valve.

*Data represents a non-randomized sample of high- or extreme-risk patients transfemorally implanted with a Portico valve using the FlexNav Delivery System between November 2018 and June 2019.
^†Data represents a subset of high- or extreme-risk patients implanted with an Evolut R, Evolut PRO, or Sapien 3 valve via a transfemoral or alternative access approach between September 2014 and October 2017. Patients were enrolled as part of a separate pivotal randomized study arm of the PORTICO IDE trial.

EXPERIENCE MATTERS

The PORTICO I Post-Market Clinical Follow-up study*, using the previous-generation delivery system, demonstrates excellent short- and long-term clinical outcomes across a broad implanter base, including low rates of PVL, consistent with other leading TAVI valves.^3-8

	30-DAY COMPARISON
	PORTICO I³ Portico (N = 941)	FORWARD⁶ Evolut R (N = 1038)	SOURCE 3⁷ Sapien 3 (N = 1947)
All-Cause Mortality (%)	2.7	1.9	2.2
Disabling Stroke (%)	1.6	1.7	0.5
Life-Threatening or Disabling Bleeding (%)	3.1	3.7	5.0
Major Vascular Complications (%)	5.5	6.9	4.1
AKI III (%)	3.0	1.1	1.1
New Permanent Pacemaker (%)	18.7	20.2	12.0

*The Portico I study was conducted via transfemoral access.

IMPLANTER EXPERIENCE IMPACTS PVL

FROM A PORTICO I POST HOC ANALYSIS:

2.6%
PVL

"Sites performing > 15 procedures achieved a lower rate of moderate or higher PVL than sites with fewer procedures" (2.6% versus 7.2%, p = < 0.01, 30-day comparison). —Maisano et al. EuroIntervention 2018
LOW RATES OF CLINICALLY-SIGNIFICANT PVL

At 30 days and 1 year, Portico valves demonstrate low rates of moderate or higher PVL consistent with other leading TAVI valves.^3-8

30 DAYS (% ≥ Moderate PVL)

7.2%
PORTICO I^3,5
Portico
(N = 194)
Site ≤ 15 IMPLANTS

2.6%
PORTICO I^3,5
Portico
(N = 495)
Site > 15 IMPLANTS

2.0%^*
FORWARD⁶
Evolut R
(N = 813)

3.1%
SOURCE 3⁷
Sapien 3
(N = N/A)

1 YEAR (% ≥ Moderate PVL)

2.6%
PORTICO I⁴
Portico
(N = 573)

1.2%
FORWARD⁶
Evolut R
(N = 587)

2.6%
SOURCE 3⁸
Sapien 3
(N = 1007)

*At discharge.

Features Patients Who Benefit

Deliverability Redefined.
TAVI Reimagined.

Experience Remarkable
Deliverability.

Portico with FlexNav
TAVI System.

MAT-1901240 v1.0

References

Fontana GP. Primary Outcomes of the PORTICO Randomized IDE Trial: Portico vs. Commercially Available Transcatheter Aortic Valves in High and Extreme Risk Patients. Presented at TCT 2019.
Fontana GP. Safety Outcomes from the Portico IDE FlexNav Delivery System Study of 100 High and Extreme Risk Patients. Presented at London Valves Meeting 2019.
Maisano F, et al. Early commercial experience from transcatheter aortic valve implantation using the Portico™ bioprosthetic valve: 30-day outcomes in the multicentre PORTICO-1 study. EuroIntervention 2018;14(8):886-893.
Sondergaard L, et al. One-year outcomes with a self-expanding, repositionable transcatheter heart valve in severe aortic stenosis patients: PORTICO-I. J Am Coll Cardiol. 2018. Epub ahead of print. doi: 10.1016/j_jacc.2018.09.014.
Abbott, Data on File.
Manoharan G, et al. 1-year outcomes with the Evolut R self-expanding transcatheter aortic valve. From the international FORWARD study. J Am Coll Cardiol Intv. 2018;11(22):2326-34.
Wendler O, et al. SOURCE 3 Registry: Design and 30-day results of the European post approval registry of the latest generation of the Sapien 3 transcatheter heart valve. Circulation. 2017;135(12):1123-1132.
Wendler O, et al. SOURCE 3: 1-year outcomes post-transcatheter aortic valve implantation using the latest generation of the balloon-expandable transcatheter heart valve. Eur Heart J. 2017;38(36):2717-2726.

Transcatheter

Surgical

Stroke Risk Reduction

Congenital Defects