[Federal Register Volume 80, Number 172 (Friday, September 4, 2015)]
[Notices]
[Pages 53549-53550]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-21969]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent Commercialization
License: Cerclage Annuloplasty Devices for Treating Mitral Valve
Regurgitation
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: This is notice, in accordance with 35 U.S.C. 209 and 37 CFR
404, that the National Institutes of Health (NIH), Department of Health
and Human Services, is contemplating the grant of a worldwide exclusive
license to practice the inventions embodied in:
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NIH Ref No. Patent application No. Filing date Title
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E-048-2009/0-US-01................. 61/157,267............. March 4, 2009......... Cerclage Locking Device
And Delivery System.
E-048-2009/0-PCT-02................ PCT/US2010/026245...... March 4, 2010......... Cerclage Locking Device
And Delivery System.
E-048-2009/0-US-03................. 13/254,160............. March 4, 2010......... Cerclage Locking Device
And Delivery System.
E-108-2010/0-US-01................. 61/383,061............. September 15, 2010.... Methods and Devices For
Transcatheter Cerclage
Annuloplasty.
E-108-2010/0-PCT-02................ PCT/US2011/51748....... September 15, 2011.... Methods and Devices For
Transcatheter Cerclage
Annuloplasty.
E-108-2010/0-EP-03................. 11760945.3............. September 15, 2011.... Methods and Devices For
Transcatheter Cerclage
Annuloplasty.
E-108-2010/0-US-04................. 13/824,198............. March 15, 2013........ Methods and Devices For
Transcatheter Cerclage
Annuloplasty.
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To Transmural Systems, LLC, a limited liability company incorporated
under the laws of the State of Massachusetts and having its principle
place of business in Andover, Massachusetts.
The contemplated exclusive license may be limited to cerclage
annuloplasty devices for treating mitral valve regurgitation.
DATES: Only written comments and/or applications for a license that are
received by the NIH Office of Technology Transfer on or before October
5, 2015 will be considered.
[[Page 53550]]
ADDRESSES: Requests for a copy of the patent application, inquiries,
comments and other materials relating to the contemplated license
should be directed to: Michael Shmilovich, Esq. Senior Licensing and
Patenting Manager, Office of Technology Transfer, National Institutes
of Health, 6011 Executive Boulevard, Suite 325, Rockville, MD 20852-
3804; Telephone: (301) 435-5019; Facsimile: (301) 402-0220; Email:
[email protected].
SUPPLEMENTARY INFORMATION:
E-048-2009
The invention relates to a device that can be used to non-
invasively secure surgical suture loops when combined with a
percutaneous delivery system. It has been shown to be effective in
correcting mitral valve regurgitation (MVR) in an animal model. During
the procedure, a guidewire is percutaneously conveyed to the atrium of
the heart and is used to secure the ``cerclage'' suture encircling the
mitral valve annulus, which is delivered using a delivery catheter. The
locking device is advanced over the suture by the delivery catheter and
it permanently secures the suture and maintains the tension on the
annulus once the delivery system is removed. This locking device, in
combination with the percutaneous procedure, allows for more complete
coaptation of the valve leaflets and correction of MVR without the need
for open heart surgery and its associated risks. The locking device is
also adjustable, allowing the user to vary the tension on the suture if
further tightening or loosening is required. It is also MRI compatible
and all follow-up studies can be performed under MRI. This invention
demonstrated its ability to correct MVR in animals where the locking
device was observed to maintain the correct position and tension after
implantation. This device has the potential to replace the traditional
loop and knot method used for surgical correction of MVR, and may also
be useful for other conditions that require permanently secured suture
loops.
E-108-2010
The invention relates to techniques and devices for cardiovascular
valve repair, particularly annuloplasty techniques and devices in which
tensioning elements are positioned to treat regurgitation of the mitral
valve or tricuspid valve. More specifically, the technology pertains to
a new device for myocardial septal traversal (``cerclage reentry'')
that also serves to capture (ensnare) and externalize the traversing
guidewire. The focus of the invention is to avoid a phenomenon in
cardiac surgery known as ``trabecular entrapment.'' The device features
an expandable and collapsible mesh deployed in the right ventricle to
simplify capture of a reentering guidewire during transcatheter
cerclage annuloplasty. The wire mesh exerts pressure against
trabecular-papillary elements of the tricuspid valve to displace them
against the right ventricular septal wall. By abutting the right
ventricular reentry site of the cerclage guidewire, trabecular
entrapment is avoided. The device comprises a shaft having a distal
loop which provides a target in the interventrical myocardial septum
through which a catheter-delivered tensioning system is guided. The
loop ensnares the catheter-delivered tensioning system as it reenters
the right ventricle or right atrium. The expandable and collapsible
mesh is disposed within the right ventricle such that the catheter-
delivered tensioning system is directed from the ventricular septum
into the right ventricular cavity through only a suitable opening in
the mesh and such that the catheter delivered tensioning system is
captured or ensnared within the mesh opening.
The prospective exclusive license will be royalty bearing and will
comply with the terms and conditions of 35 U.S.C. 209 and 37 CFR 404.
The prospective exclusive license may be granted unless, within thirty
(30) days from the date of this published notice, NIH 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 404. Properly filed competing applications for a license filed in
response to this notice will be treated as objections to the
contemplated license. Comments and objections submitted in response 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: September 1, 2015.
Richard U. Rodriguez,
Acting Director, Office of Technology Transfer, National Institutes of
Health.
[FR Doc. 2015-21969 Filed 9-3-15; 8:45 am]
BILLING CODE 4140-01-P