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Implantable Unpinning Termination Therapy for Cardiac Arrhythmias

Award Number: R44HL107055
ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 02/15/2011
PERIOD OF PERFORMANCE END DATE: 06/30/2025

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Implantable Unpinning Termination Therapy for Cardiac Arrhythmias - Project Summary/Abstract We propose the development and evaluation of a novel implantable low-energy device, using an innovative low-energy multi-pulse therapy, to achieve well-tolerated treatment of ventricular and atrial tachyarrhythmias. Ventricular arrhythmias (VAs) including ventricular tachycardia (VT) and ventricular fibrillation (VF) are responsible for 75-80% of Sudden Cardiac Death (SCD) cases. Sudden cardiac death kills nearly 450,000 Americans yearly. In the majority of these patients, the most common initial arrhythmia is sustained VT which can degrade into VF. A high-energy biphasic shock delivered by an implantable cardiac defibrillator (ICD) is the only existing therapy to terminate VA when low-energy anti-tachycardia pacing fails. These high energy shocks are associated with increased mortality and severe pain. Similarly, atrial fibrillation (AF), an atrial tachyarrhythmia, is a global epidemic. Approximately 33.5 million individuals are affected worldwide and close to 5 million new cases occur each year costing the US healthcare system between $6 and $26 billion annually. AF is a progressive disease with many patients first developing paroxysmal atrial fibrillation (PAF). Left untreated, PAF can progress to persistent or permanent AF. Because of rapid changes in the atria after AF onset, a therapy to treat AF soon after onset may slow the progressive nature of AF. There exists great enthusiasm in the medical community for AF interventions due to the limited efficacy of current treatments and risks to the patients. An effective atrial defibrillator was previously developed; however, it was abandoned due to pain associated with shocks and rapid battery depletion as a high number of high-energy shocks had to be delivered. A well-tolerated, low-energy, device-based VA and AF therapy without high-energy shocks would address a major unmet medical need. Prior canine and early stage acute human studies with a non- implantable version of the proposed system have observed that the proposed therapy approach significantly lowers the energy required for effective VT and AF therapy into ranges that have been reported as tolerated by patients. The goal of this proposed phase IIB project is to develop and test a fully implantable prototype low- energy therapy device for use in future chronic human studies under IDE exemption involving treatment of VT and AF.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2024 ( Subtotal = $0 )
2024	2023	NATIONAL BIOMEDICAL, LLC	861 E HENNEPIN AVE STE 430	MINNEAPOLIS	MN	55414	HENNEPIN	USA	Cardiovascular Diseases Research	000	6	10/26/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$0
														Subtotal = $0

Issue Date FY: 2023 ( Subtotal = $916,139 )
2023	2023	NATIONAL BIOMEDICAL LLC	861 E HENNEPIN AVE	MINNEAPOLIS	MN	55414	HENNEPIN	USA	Cardiovascular Diseases Research	003	6	9/7/2023	CHANGE OF GRANTEE / TRAINING INSTITUTION / AWARDING INSTITUTION	$998,941
2023	2022	CARDIALEN, INC.	6160 SUMMIT DR N STE 450	MINNEAPOLIS	MN	55430	HENNEPIN	USA	Cardiovascular Diseases Research	000	5	10/28/2022	NON-COMPETING CONTINUATION	$0
2023	2022	CARDIALEN INC	6160 SUMMIT DR N	MINNEAPOLIS	MN	55430	HENNEPIN	USA	Cardiovascular Diseases Research	002	5	9/6/2023	NON-COMPETING CONTINUATION	$0
2023	2018	CARDIALEN INC	6160 SUMMIT DR N	MINNEAPOLIS	MN	55430	HENNEPIN	USA	Cardiovascular Diseases Research	001	3	3/14/2023	NON-COMPETING CONTINUATION	-$82,802
														Subtotal = $916,139

Issue Date FY: 2022 ( Subtotal = $999,810 )
2022	2022	CARDIALEN, INC.	6160 SUMMIT DR N STE 450	MINNEAPOLIS	MN	55430	HENNEPIN	USA	Cardiovascular Diseases Research	001	5	8/3/2022	NON-COMPETING CONTINUATION	$999,810
2022	2018	CARDIALEN INC	6160 SUMMIT DR N	MINNEAPOLIS	MN	55430	HENNEPIN	USA	Cardiovascular Diseases Research	000	3	10/30/2021	NON-COMPETING CONTINUATION	$0
														Subtotal = $999,810

Issue Date FY: 2021 ( Subtotal = $999,374 )
2021	2021	CARDIALEN, INC.	6160 SUMMIT DR N STE 450	MINNEAPOLIS	MN	55430	HENNEPIN	USA	Cardiovascular Diseases Research	000	4	6/30/2021	COMPETING CONTINUATION	$999,374
														Subtotal = $999,374

Issue Date FY: 2020 ( Subtotal = $0 )
2020	2018	CARDIALEN, INC.	6160 SUMMIT DR N STE 450	MINNEAPOLIS	MN	55430	HENNEPIN	USA	Cardiovascular Diseases Research	000	3	6/20/2020	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2019 ( Subtotal = $0 )
2019	2018	CARDIALEN, INC.	4041 FOREST PARK AVE	SAINT LOUIS	MO	63108	SAINT LOUIS CITY	USA	Cardiovascular Diseases Research	001	3	1/10/2019	NON-COMPETING CONTINUATION	$0
2019	2018	CARDIALEN, INC.	6160 SUMMIT DR N STE 450	MINNEAPOLIS	MN	55430	HENNEPIN	USA	Cardiovascular Diseases Research	002	3	4/1/2019	NON-COMPETING CONTINUATION	$0
2019	2017	CARDIALEN, INC.	4041 FOREST PARK AVE	SAINT LOUIS	MO	63108	SAINT LOUIS CITY	USA	Cardiovascular Diseases Research	000	2	1/9/2019	COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2018 ( Subtotal = $641,076 )
2018	2018	CARDIALEN, INC.	4041 FOREST PARK AVE	SAINT LOUIS	MO	63108	SAINT LOUIS CITY	USA	Cardiovascular Diseases Research	000	3	8/6/2018	NON-COMPETING CONTINUATION	$641,076
														Subtotal = $641,076

Issue Date FY: 2017 ( Subtotal = $1,351,728 )
2017	2017	CARDIALEN, INC.	4041 FOREST PARK AVE	SAINT LOUIS	MO	63108	SAINT LOUIS CITY	USA	Cardiovascular Diseases Research	000	2	6/12/2017	COMPETING CONTINUATION	$1,351,728
														Subtotal = $1,351,728

Grand Total All Awards = $4,908,127

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Implantable Unpinning Termination Therapy for Cardiac Arrhythmias

Award Number: R44HL107055

ORGANIZATION: NATIONAL HEART, LUNG, & BLOOD INSTITUTE

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 02/15/2011

PERIOD OF PERFORMANCE END DATE: 06/30/2025

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