Notice2026-07147
Prospective Grant of Exclusive Patent License: Catheter-Based Myotomy Devices And Systems
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
April 14, 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 Septune, Inc., located in San Juan, Puerto Rico, to practice the inventions embodied in the patent applications listed in the SUPPLEMENTARY INFORMATION section of this notice.
Full Text
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<title>Federal Register, Volume 91 Issue 71 (Tuesday, April 14, 2026)</title>
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[Federal Register Volume 91, Number 71 (Tuesday, April 14, 2026)]
[Notices]
[Pages 19144-19145]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-07147]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of Exclusive Patent License: Catheter-Based
Myotomy Devices And Systems
AGENCY: National Institutes of Health.
ACTION: Notice.
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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 Septune,
Inc., located in San Juan, Puerto Rico, 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
May 14, 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#25564d484c494a5348654b4c4d0b424a53"><span class="__cf_email__" data-cfemail="46352e2b2f2a29302b06282f2e68212930">[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 Septune,
Inc.:
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Patent No. or
NIH Ref No. application No. Filing date Title
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E-194-2025-0-US-01................. 63/890,784 September 30, 2025.... Electrosurgical Myotomy
Catheter System.
E-166-2022-0-US-01................. 63/383,012 November 9, 2022...... Myotomy Catheter System
And Methods For A Myotomy
Catheter System.
E-166-2022-0-PC-01................. PCT/US2023/079114 November 8, 2023...... Myotomy Catheter System
And Methods For A Myotomy
Catheter System.
E-166-2022-0-US-02................. 19/127,710 November 8, 2023...... Myotomy Catheter System
And Methods For A Myotomy
Catheter System.
E-166-2022-0-EP-01................. 23821091.8 November 8, 2023...... Myotomy Catheter System
And Methods For A Myotomy
Catheter System.
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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 myocardial myotomy systems for the treatment of
cardiovascular disease.
The invention described in E-194-2025 for which we currently have a
provisional patent application covers a variable-depth electrosurgical
myotomy catheter system configured to perform a longitudinal
endomyocardial myotomy, also referred to as septal scoring along the
midline endocardium (SESAME). The catheter system is configured to
slice the ``septal hump'' causing symptomatic left ventricular outflow
tract obstruction in hypertrophic cardiomyopathy (HCM), a common
congenital heart disease in adults and children. The system may have
further applications in creating space to allow non-surgical
transcatheter mitral valve implantation (TMVR), which excludes more
than half of TMVR candidates, and potentially reduces left ventricular
stiffness causing heart failure with preserved ejection fraction
(HFpEF), a widely prevalent disease.
The invention described in E-166-2022, for which we now have
pending national stage applications in the US and Europe, pertains to a
controlled-depth myotomy catheter system configured to perform a
longitudinal endomyocardial myotomy (also referred to as septal scoring
along the midline endocardium (SESAME)) precisely and reproducibly with
less operator skill than previous SESAME procedures, less reliance on
image guidance, and lowered procedure times. SESAME is conventionally
accomplished by navigating a 0.014'' guidewire under x-ray fluoroscopy
and ultrasound guidance via a retrograde transaortic guiding catheter
through the interventricular septum. A straight rigid engagement
guidewire engages the basal
[[Page 19145]]
septum either mechanically or electrosurgically to allow a 0.014''
microcatheter to enter the basal septum. The instant invention replaces
the 0.014'' engagement guidewire is with a 0.014'' curved-tip guidewire
navigated through the septal myocardium towards the apex until it exits
the myocardium and reenters the left ventricular chamber. The
trajectory may be confirmed by ultrasound. The intracameral guidewire
tip is ensnared to allow positioning of an inner-curvature-denuded
laceration surface resembling the ``flying-V'' used for other
procedures such as laceration of the anterior mitral leaflet to prevent
outflow obstruction (LAMPOON). The ``flying-V-like'' configuration
includes insulating microcatheters on both free limbs of the lacerating
guidewire. Once positioned, the laceration surface is electrified under
traction to accomplish SESAME. Currently, SESAME also requires general
anesthesia and advanced imaging including combinations of
transthoracic, transesophageal, and intracardiac ultrasound, even
within the left ventricular chamber, as well as biplane fluoroscopy.
Ultrasound imaging windows across the chest wall, from the esophagus,
and even within heart chambers are usually insufficient to give high
confidence in the guidewire position along its whole trajectory. As
explained previously, the uncertain depth of endomyocardial scoring via
conventional SESAME may result in too shallow a laceration (resulting
in therapeutic failure) or too deep a laceration (resulting in
ventricular septal defect or free wall rupture). Conversely, the device
disclosed in E-166-2022 addresses these issues by providing a
controlled-depth laceration. The myotomy catheter system may be
referred to as a transcatheter articulated heart incision instrument
(TAHINI) catheter system. The TAHINI catheter system includes an
incision catheter and an anchor stabilization and orientation catheter
system configured to stabilize and properly orient the incision
catheter. The anchor stabilization and orientation catheter system
includes one or more anchors that are configured to be positioned in
the heart to guide the incision catheter to perform SESAME. The
anchor(s) may include mural anchors that enter or traverse the wall of
the heart (e.g., the septum) and/or endocameral stabilizing hoops (that
stabilize the catheter within a heart chamber, such as the left
ventricle). The incision catheter may include an articulated cutting
tool (e.g., a lacerator/blade that can be insulated from other metal
components and electrified to perform electrosurgery) that, when
deployed, is angled relative to the septal myocardium (e.g.,
tangential) such that traction-withdrawal along an anchored guidewire
causes the cutting tool to embed deeply into the septal myocardium.
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: April 9, 2026.
Michael Shmilovich,
Acting Director, National Heart, Lung, and Blood Institute, Office of
Technology Transfer and Development.
[FR Doc. 2026-07147 Filed 4-13-26; 8:45 am]
BILLING CODE 4140-01-P
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