Download Background Relevant Clinical Experience The BAROSTIM NEO

Baroreflex Activation
™
Therapy
for Heart Failure
Study
Steering Committee:
1
MD ,
William T. Abraham,
JoAnn Lindenfeld,
2
MD
Fred A. Weaver,
1 Division
3
MD ,
Faiez Zannad,
4
MD ,
Michael R. Zile,
5
MD
2 Vanderbilt
of Cardiovascular Medicine, The Ohio State University, Columbus, OH, USA;
Heart and Vascular Institute, Nashville, TN, USA;
3 Division of Vascular Surgery and Endovascular Therapy, Keck School of Medicine, University of Southern California, Los Angeles, CA, USA;
4 Inserm Centre d'Investigation, CHU de Nancy, Institut Lorrain du Coeur et des Vaisseaux, Université de Lorraine, Nancy, France;
5 Division of Cardiology, Department of Medicine, Medical University of South Carolina, Charleston, SC, USA
The BAROSTIM NEO ™ System
Background
• Heart failure is characterized by a hyperadrenergic state with suppressed parasympathetic
tone and secondary deleterious neurohormonal effects
• Despite improved guideline adherence and targeted medical therapy, outcomes in
reduced-ejection fraction heart failure (HFrEF) remain unsatisfactory
• BAROSTIM THERAPY™ is a unique treatment option for HFrEF that delivers electrical
stimulation to the carotid sinus to activate the baroreflex and reduce sympathetic activity
while restoring parasympathetic activity
• Phase 1 (n=11) and Phase 2 (n=146) studies of BAROSTIM THERAPY in HFrEF patients
have demonstrated that chronic baroreflex activation significantly1,2:
• Improves autonomic balance and reduces neurohormonal activation
• Improves six minute hall walk (6MHW), Minnesota Living With HF Quality of Life
(MLWHF) and NYHA functional class
• Reduces heart failure hospitalization burden
Implantable Pulse
Generator (IPG)
Implanted under the skin
below the collarbone.
Provides control and delivery
of activation energy from the
IPG to the baroreceptors on
the carotid artery.
Carotid Sinus Lead
One thin lead wire
implanted on the carotid
artery and connected to
the device. Conducts
activation energy from the
IPG to the baroreceptors
on the carotid artery.
Key Eligibility Criteria
Inclusion
Wireless Programmer
System
• Symptomatic NYHA Class III
• Left ventricular ejection fraction ≤ 35%
An external system used
to adjust and customize
therapy settings via
wireless communication.
• Heart failure defined as:
• BNP≥ 400 or NT-proBNP ≥ 1600
OR
• BNP ≥ 100 or NT-proBNP ≥400 AND
prior hospitalization for heart failure
within 12 months.
• On optimal, stable, Guideline Directed
Medical Therapy for the treatment of heartfailure
Relevant Clinical Experience
Study Design & Objectives
In non-CRT patients, results at six months showed that symptoms, functional capacity, and
cardiovascular function were significantly improved, while heart failure hospitalization days
were reduced in those who received Baroreflex Activation Therapy (BAT) compared to those
in the control arm (BAT n=47; Control n=48) 3
The BAROSTIM NEO device for this study patient population has received Expedited Access
Pathway designation from FDA4. This designation is for medical devices that demonstrate
the potential to address unmet medical needs for patients with life threatening or irreversibly
debilitating diseases. Improvement in intermediate endpoints, which is of value to these
patients, has been incorporated into the study design to support evaluation of safety and
efficacy.
Improves Quality of Life (Minnesota Living with Heart Failure)
60
40
IMPROVEMENT
82 meters
p=0.003
4
0
-5
-10
-15
-20
Center Requirements
• Large heart failure population
• Large cardiology practice
• Strong collaboration with vascular surgery
• Electronic medical records
• Prior experience with randomized device studies
-22
IMPROVEMENT
25 points
p<0.001
Centers interested in participating in BeAT-HF should contact
Liz Galle, Senior Director of Clinical Research: [email protected]
20
-25
4
0
-30
Control
BAT
• Heart failure secondary to a reversible
cause
• Dedicated research coordinator
Improvement
86
80
• AHA/ACC Stage D heart failure
• Significant patient recruitment in previous heart failure studies
5
←
100
6 Month Change from Baseline
Points
10
Improvement →
6 Month Change from Baseline
Meters
120
• Currently implanted with, or currently
have, a Class 1 indication according to
AHA/ACC guidelines for a cardiac
resynchronization therapy device
• Known or suspected baroreflex failure or
autonomic neuropathy
• Six-minute hall walk ≥ 150 m AND ≤ 400 m
• BAROSTIM THERAPY is particularly effective in patients who are not eligible for cardiac
resynchronization therapy (CRT), a population in need of new therapeutic options
Improves Six Minute Hall Walk Distance
Exclusion
BAT
Control
References
Reduces NT-pro BNP
Improves Left Ventricular Ejection Fraction
6
200
0
116
-97
-200
-400
1
5
4
3
2
1
Improvement →
400
IMPROVEMENT
318 pg/mL
p=0.03
Improvement
600
6 Month Change from Baseline
%
800
←
6 Month Change from Baseline
median pg/mL
1000
4.3
IMPROVEMENT
4.4 Percentage Points
p=0.03
0
-0.1
-600
-1
-800
-2
BAT
Control
BAT
Control
2
Safety:
• Event-free rate of all system- and procedure-related Major Adverse Neurological and
Cardiovascular Events occurring within 6 months post-implant
Efficacy:
• Six Minute Hall Walk, Minnesota Living with Heart Failure Quality of Life, NT-proBNP
• Cardiovascular mortality and worsening heart failure (M&M)
3
4
Gronda E et al., European Journal of Heart Failure. 2014;16:977–983
Abraham WT et al., JACC: Heart Failure. 2015; 3:487-496
Zile MR et al., European Journal of Heart Failure. 2015;17:1066–1074.
http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddevgen/documents/document/ucm393978.pdf
The BAROSTIM NEO system is CE Marked and approved for sale for heart failure patients in Europe. It
is also CE Marked and approved for sale for hypertension patients in Europe. Caution: BAROSTIM
NEO is an investigational device and is limited by United States law to investigational use. CVRx,
BAROSTIM NEO, Baroreflex Activation Therapy and BAROSTIM THERAPY are all trademarks of
CVRx, Inc. © 2016 CVRx, Inc. All rights reserved.