Notice2026-22339
Prospective Grant of Exclusive Patent License: Catheter-Based Intramyocardial Ablation for Treating Ventricular Arrhythmia in a Human
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
November 2, 2026
Issuing agencies
Health and Human Services DepartmentNational Institutes of Health
Abstract
The National Heart, Lung and Blood Institute (NHLBI), National Institutes of Health, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to AntaraCore, Systems, Inc., located in Dover, Delaware, to practice the inventions embodied in the patent applications listed in the SUPPLEMENTARY INFORMATION section of this notice.
Full Text
<html>
<head>
<title>Federal Register, Volume 91 Issue 210 (Monday, November 2, 2026)</title>
</head>
<body><pre>
[Federal Register Volume 91, Number 210 (Monday, November 2, 2026)]
[Notices]
[Pages 68963-68964]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-22339]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent License: Catheter-Based
Intramyocardial Ablation for Treating Ventricular Arrhythmia in a Human
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The National Heart, Lung and Blood Institute (NHLBI), National
Institutes of Health, Department of Health and Human Services, is
contemplating the grant of an exclusive patent license to AntaraCore,
Systems, Inc., located in Dover, Delaware, to practice the inventions
embodied in the patent applications listed in the SUPPLEMENTARY
INFORMATION section of this notice.
DATES: Only written comments and/or applications for a license which
are received by the NHLBI Office of Technology Transfer and Development
December 2, 2026 will be considered.
ADDRESSES: Requests for copies of the patent applications, inquiries,
and comments relating to the contemplated exclusive patent license
should be directed to: Michael Shmilovich, Esq., MS, CLP, Acting
Director, phone number 301-435-5019 or <a href="/cdn-cgi/l/email-protection#44372c292d282b3229042a2d2c6a232b32"><span class="__cf_email__" data-cfemail="aad9c2c7c3c6c5dcc7eac4c3c284cdc5dc">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION: The following and all continuing U.S. and
foreign patents/patent applications thereof are the intellectual
properties to be licensed under the prospective license to AntaraCore
Systems, Inc.:
----------------------------------------------------------------------------------------------------------------
NIH Ref. No. Patent No. or Application No. Filing date Title
----------------------------------------------------------------------------------------------------------------
E-017-2024-0-US-01................. 66/555,802....................... 2/20/2024 Systems and Methods for
Intramyocardial Ablation
(VINTAGE).
E-017-2024-1-US-01................. 63/716,145....................... 11/4/2024 Systems and Methods for an
Ablation Catheter for
Intramyocardial Ablation.
E-017-2024-2-US-01................. 63/716,158....................... 11/4/2024 Systems and Methods for a
Myocardial Accessor
Catheter for
Intramyocardial Ablation.
E-017-2024-1-PC-01................. PCT/US2025/053823................ 11/3/2025 SYSTEMS and Methods for an
Ablation Catheter for
Intramyocardial Ablation.
E-017-2024-2-PC-01................. PCT/US2025/053825................ 11/3/2025 SYSTEMS and Methods for a
Myocardial Accessor
Catheter for
Intramyocardial Ablation.
E-017-2024-3-PC-01................. PCT/US2025/016665................ 2/20/2025 Systems and Methods for
Intramyocardial Ablation
(Vintage).
E-017-2024-3-US-01................. 19/616,776....................... 8/19/2026 Systems and Methods
Intromyocardial Ablation
(Vintage).
E-017-2024-3-EP-01................. 25711938.8....................... 8/6/2026 Systems and Methods for
Intromyocardial Ablation.
E-061-2022-0-PC-01................. PCT/US2023/021238................ 5/5/2023 Systems and Method for
Synchronous
Circumferential
Intramyocardial
Resynchronization and
Pacing.
E-061-2022-0-US-02................. 18/863,596....................... 11/6/2024 Systems and Method for
Synchronous
Circumferential
Intramyocardial
Resynchronization and
Pacing.
E-061-2022-0-IL-01................. 316835........................... 11/5/2024 Systems and Method for
Synchronous
Circumferential
Intramyocardial
Resynchronization and
Pacing.
E-061-2022-0-EP-01................. 23729551.4....................... 11/3/2024 Systems and Method for
Synchronous
Circumferential
Intramyocardial
Resynchronization and
Pacing.
----------------------------------------------------------------------------------------------------------------
[[Page 68964]]
The patent rights in these inventions have been assigned to the
Government of the United States of America. The prospective exclusive
patent license territory may be worldwide and in a field of use limited
to catheter-based intramyocardial ablation, for treating ventricular
arrhythmia in a human.
This patent license covers two patent estates as shown above,
namely the invention described in the E-017-2024 estate, and the
invention described in the E-061-2022 estate. ``Intramural substrates''
are the crux of the clinical challenge addressed by the subject patent
estates and the proposed field of use. Specifically, these intramural
substrates are the electrically conducting and hard-to-reach
arrhythmogenic tissue located within the depth of the myocardial wall--
the mid-myocardium--rather than on the endocardial (inner) or
epicardial (outer) surfaces. The inventions being exclusively licensed
herein provide a catheter-based system and method to access these
intramyocardium tissues, and a synchronous circumferential
intramyocardial resynchronization and pacing (SCIRP) system intended to
improve cardiac resynchronization therapy. Both of these inventions
together provide a new and improved device, system and method to enable
electrophysiologists to access and treat arrhythmogenic intramural
substrates located within the ventricular myocardial wall, which
currently is not systematized.
The invention described in E-017-2024, for which we have 3
provisional applications, 3 PCT applications, a pending U.S. national
stage application and a pending European national stage application,
covers a catheter-based system and method for performing ablation
directly within the intramyocardium and particularly targeting
ventricular tachycardia that is otherwise difficult to reach using
existing ablation devices and methods. The system, referred to as
VINTAGE (Ventricular Intramyocardial Navigation for Tachycardia
Ablation Guided by Electrograms), principally uses a small flexible
ablation microcatheter that tracks coaxially over a steerable,
electrically insulated guidewire. Proximal to the catheter tip are
mapping electrodes and a conductive ablation electrodes with
perforations that can elute irrigants directly into the surrounding
myocardial tissue. The physician navigates to the desired deep target
using fluoroscopy, ultrasound, electroanatomic mapping and/or
electrogram-based depth navigation (EDEN); once the ablation electrode
reaches the target, irrigant is delivered through its openings and
radiofrequency energy applied while irrigation continues, producing a
controlled lesion in the abnormal tissue responsible for the
arrhythmia. The irrigant may be an electrolyte acting to alter the
electrical and/or physicochemical characteristics of the target
myocardial substrate (such as increasing ionic conductivity), act as a
thermo-conductive ``virtual ablation electrode'', or may alternatively
be a caustic agent intended to effect adjunctive chemoablation.
The invention described in E-061-2022, for which we have a PCT
application, a pending U.S. national stage application, a pending
Isreali national stage application and a pending European application,
covers a synchronous circumferential intramyocardial resynchronization
and pacing (SCIRP) system intended to improve cardiac resynchronization
therapy by placing a flexible, multi-electrode pacing lead inside the
ventricular myocardium rather than on an endocardial or epicardial
surface. The lead contains multiple small ring electrodes and is
implanted along a curved trajectory that can extend at least 180
degrees--and potentially substantially around the circumference--of the
left ventricle, including through the interventricular septum near the
His bundle or left bundle branch. Of particular import is the ability
to introduce these electrodes into the ventricular intramural spaces
through a navigated guidewire introduced through the myocardium using
electrograms or pace mapping, and leaving the electrode-bearing lead
embedded in the heart muscle. A multichannel pulse generator then
energizes selected myocardium implanted electrodes in unipolar or
bipolar configurations directly stimulate ventricular muscle and, where
appropriately positioned, the native His/LBB conduction system. In
essence, instead of trying to resynchronize the ventricle from a few
conventional surface pacing sites, the invention creates an
intramyocardial array of pacing sites distributed around the ventricle,
intended to re homogenize synchronization.
This notice is made in accordance with 35 U.S.C. 209 and 37 CFR
part 404. The prospective exclusive patent license will be royalty
bearing and may be granted unless within thirty (30) days from the date
of this published notice, the NHLBI receives written evidence and
argument that establishes that the grant of the license would not be
consistent with the requirements of 35 U.S.C. 209 and 37 CFR part 404.
Complete applications for a license in the prospective field of use
that are timely filed in response to this notice will be treated as
objections to the grant of the contemplated exclusive patent license.
Comments and objections submitted to this notice will not be made
available for public inspection and, to the extent permitted by law,
will not be released under the Freedom of Information Act, 5 U.S.C.
552.
Dated: October 28, 2026.
Michael Shmilovich,
Acting Director, National Heart, Lung, and Blood Institute, Office of
Technology Transfer and Development, National Institutes of Health.
[FR Doc. 2026-22339 Filed 10-30-26; 8:45 am]
BILLING CODE 4167-05-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on November 2, 2026.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.