[Federal Register Volume 82, Number 58 (Tuesday, March 28, 2017)]
[Notices]
[Pages 15363-15364]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2017-06036]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health
Prospective Grant of an Exclusive Patent License for
Commercialization: Cerclage Annuloplasty Devices for Treating Mitral
Valve Regurgitation
AGENCY: National Institutes of Health, HHS.
ACTION: Notice.
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SUMMARY: 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 No. or application No. Filing date Title
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E-249-2006/0-US-01............... 60/858,716 November 14, 2006.. A Device To Protect
Coronary Arteries
Against Compression
During Transcatheter
Mitral Valve
Annuloplasty (PMVA).
E-249-2006/1-US-01............... 60/932,611 May 31, 2006.......
E-249-2006/2-PCT-01.............. PCT/US2007/023876 November 13, 2007..
E-249-2006/2-EP-02............... 07861997.0 November 13, 2007.. Transcatheter Coronary
Sinus Mitral Valve
Annuloplasty Procedure
And Coronary Artery And
Myocardial Protection
Device.
E-249-2006/2-US-03............... 8,211,171 November 13, 2007..
E-249-2006/2-US-04............... 9,271,833 November 13, 2007..
E-249-2006/3-US-01............... 15/056,599 February 29, 2016.. Transcatheter Coronary
Sinus Mitral Valve
Annuloplasty Procedure
and Coronary Artery and
Myocardial Protection
Device with ``Landing
Zone''.
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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 NIH at the address indicated below on or before April 12,
2017 will be considered.
ADDRESSES: Requests for a copy of any unpublished patent application,
inquiries, objections to this notice, comments and other requests
relating to the contemplated license should be directed to: Michael
Shmilovich, Esq., CLP, Senior Licensing and Patent Manager, 31 Center
Drive Room 4A29, MSC2479, Bethesda, MD 20892-2479, phone number 301-
435-5019, or [email protected].
SUPPLEMENTARY INFORMATION: This notice is published in accordance with
35 U.S.C. 209(c)(1) and 37 CFR 404.7(a)(1)(i).
Mitral regurgitation (MR) is amongst the most common valvular heart
disorders, with an estimated prevalence of approximately 1.7% in the
United States, increasing with age to approximately 9.3% in those over
the age of 75. MR is classified as primary (also known as ``organic'')
when principally due to a structural or degenerative abnormality of the
mitral valve (MV), whether of the leaflets, chordae tendineae,
papillary muscles, or mitral annulus. Secondary (also known as
functional) MR occurs in the absence of organic MV disease, usually
from left ventricular (LV) dysfunction. It is more common than primary
MR and is associated with a worse prognosis (compounded by the
underlying cardiomyopathy), and (in contrast to primary MR) the
benefits of MV surgery are uncertain. The MV consists of two leaflets
(anterior and posterior) sitting within the annulus (see picture
below). The posterior mitral leaflet originates from the left atrial
(LA) endocardium. A subvalvular apparatus, comprising two papillary
muscles (anterolateral and posteromedial) arising from the LV
myocardium and the chordae tendineae, supports the leaflets. LV
dilation due to ischemic or nonischemic cardiomyopathy secondarily
impairs leaflet coaptation of a structurally normal MV, resulting in
secondary MR. Specifically, LV dysfunction and remodeling lead to
apical and lateral papillary muscle displacement, resulting in leaflet
tethering, dilation and flattening of the mitral annulus, and reduced
valve closing forces.
The subject mitral repair system devices are primarily intended to
treat secondary mitral regurgitation. The proposed mitral cerclage with
coronary artery protection is an approach capable of overcoming many of
the problems that exist with existing devices namely allowing a larger
subset of patients to be treated compared to other coronary sinus
devices, providing a full annuloplasty type device which is flexible
enough to preserve annular motion, reduce hospitalization costs and
shorten recovery time. The associated method closely resembles the
surgical placement of a full annuloplasty ring.
E-249-2009/0-2
Catheter-based mitral valve regurgitation treatments that use
coronary sinus trajectory or coronary sinus implant can have unwanted
effects because the coronary sinus and its branches have been found to
cross the outer diameter of major coronary
[[Page 15364]]
arteries in a majority of humans. As a result, pressure applied by any
prosthetic device in the coronary sinus (such as tension on the
annuloplasty device) can compress the underlying coronary artery and
induce myocardial ischemia or infarction. This invention pertains to
devices and methods that avoid constricting coronary artery branches
during coronary sinus-based annuloplasty. These devices and methods
protect coronary artery branches from constriction during trans-sinus
mitral annuloplasty. The device protects a coronary vessel from
compression during mitral annuloplasty by extending an annuloplasty
element, such as a tensioning device, at least partially through the
coronary sinus over a coronary artery. The device is a surgically
sterile bridge configured for placement within the coronary sinus at a
location where the coronary sinus passes over a coronary artery, so
that the protection device provides a support for a mitral annuloplasty
element, such as a compressive prosthesis, including a tension element
when it is placed under tension. The protection device has an arch of
sufficient rigidity and dimensions to support the tensioning element
over the coronary artery, redistribute tension away from an underlying
coronary artery, and inhibit application of pressure to the underlying
artery, for example when an annuloplasty tension element is placed
under tension during mitral annuloplasty. In particular, the protective
device can be a support interposed in the coronary sinus between the
annuloplasty device and the coronary artery. The device may be
substantially tubular so that the tensioning element is contained
within the protective device and supported in spaced relationship to
the coronary artery. An arch may be configured to extend between a
proximal end and a distal end that are substantially collinear with one
another so that the ends form stabilizing members such as feet that
retain the bridge in position over the coronary artery.
E-249-2009/3
Another embodiment of the cerclage protection device is a
combination with a cerclage tension element that can be used to
facilitate transcatheter mitral valve implantation. The transcatheter
strategy includes a ``valve-in-ring'' wherein a cerclage annuloplasty
is first performed. During the same session or during a separate
procedure, a transcatheter mitral valve implantation could be performed
that would take advantage of the cerclage annuloplasty system to serve
as a visual and a mechanical ``landing zone'' for mitral valve
implantation. A cerclage annuloplasty ring would allow outward
expansion of the mitral valve to achieve fixation. However, without the
cerclage protection device in place, such a strategy would cause
compression of an entrapped coronary artery. This new embodiment of the
protection device protects coronary arteries not from extrinsic
compression but from ``inside-out'' compression, thereby allowing
cerclage to be the first step for transcatheter mitral valve
implantation. It also allows the latter to be employed as second-stage
adjunct or bailout for inadequate cerclage mitral valve annuoplasty.
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 404.7.
The prospective exclusive license may be granted unless, within fifteen
(15) 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 404.7.
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: March 17, 2017.
Michael Shmilovich,
Senior Licensing and Patenting Manager, Office of Technology Transfer
and Development, National Heart, Lung, and Blood Institute.
[FR Doc. 2017-06036 Filed 3-27-17; 8:45 am]
BILLING CODE 4140-01-P