Prospective Grant of an Exclusive Patent License for Commercialization: Cerclage Annuloplasty Devices for Treating Mitral Valve Regurgitation, 15363-15364 [2017-06036]
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Federal Register / Vol. 82, No. 58 / Tuesday, March 28, 2017 / Notices
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ACTION:
[FR Doc. 2017–06040 Filed 3–27–17; 8:45 am]
BILLING CODE 4140–01–P
Patent No. or
application No.
E–249–2006/1–US–01 ..........
E–249–2006/2–PCT–01 .......
E–249–2006/2–EP–02 ..........
60/932,611
PCT/US2007/023876
07861997.0
May 31, 2006.
November 13, 2007.
November 13, 2007 .............
E–249–2006/2–US–03 ..........
E–249–2006/2–US–04 ..........
E–249–2006/3–US–01 ..........
8,211,171
9,271,833
15/056,599
November 13, 2007.
November 13, 2007.
February 29, 2016 ...............
sradovich on DSK3GMQ082PROD with NOTICES
VerDate Sep<11>2014
17:14 Mar 27, 2017
Jkt 241001
National Institutes of Health,
HHS.
Notice.
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:
SUMMARY:
Transcatheter Coronary Sinus Mitral Valve Annuloplasty
Procedure And Coronary Artery And Myocardial Protection Device.
Transcatheter Coronary Sinus Mitral Valve Annuloplasty
Procedure and Coronary Artery and Myocardial Protection Device with ‘‘Landing Zone’’.
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
PO 00000
AGENCY:
A Device To Protect Coronary Arteries Against Compression During Transcatheter Mitral Valve Annuloplasty
(PMVA).
November 14, 2006 .............
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
shmilovm@mail.nih.gov.
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
Prospective Grant of an Exclusive
Patent License for Commercialization:
Cerclage Annuloplasty Devices for
Treating Mitral Valve Regurgitation
Title
60/858,716
DATES:
National Institutes of Health
Filing date
E–249–2006/0–US–01 ..........
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.
15363
Frm 00050
Fmt 4703
Sfmt 4703
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
E:\FR\FM\28MRN1.SGM
28MRN1
15364
Federal Register / Vol. 82, No. 58 / Tuesday, March 28, 2017 / Notices
sradovich on DSK3GMQ082PROD with NOTICES
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 transsinus 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
VerDate Sep<11>2014
17:14 Mar 27, 2017
Jkt 241001
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 ‘‘insideout’’ 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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
National Institutes of Health
Submission for OMB Review; 30-Day
Comment Request; Early Career
Reviewer Program Application and
Vetting System (EAVS) (Center for
Scientific Review)
AGENCY:
National Institutes of Health,
HHS.
ACTION:
Notice.
In compliance with the
Paperwork Reduction Act of 1995, the
National Institutes of Health (NIH) has
submitted to the Office of Management
SUMMARY:
PO 00000
Frm 00051
Fmt 4703
Sfmt 4703
and Budget (OMB) a request for review
and approval of the information
collection listed below. This proposed
information collection was previously
published in the Federal Register on
December 29, 2016, page 96020 (Vol. 81,
No. 250) and allowed 60 days for public
comment. No public comments were
received. The purpose of this notice is
to allow an additional 30 days for public
comment.
DATES: Comments regarding this
information collection are best assured
of having their full effect if received
within 30-days of the date of this
publication.
ADDRESSES: Written comments and/or
suggestions regarding the item(s)
contained in this notice, especially
regarding the estimated public burden
and associated response time, should be
directed to the: Office of Management
and Budget, Office of Regulatory Affairs,
OIRA_submission@omb.eop.gov or by
fax to 202–395–6974, Attention: Desk
Officer for NIH.
FOR FURTHER INFORMATION CONTACT: To
request more information on the
proposed project or to obtain a copy of
the data collection plans and
instruments, contact: Dr. Mary Ann
Guadagno, Project Clearance Liaison,
Center for Scientific Review, NIH, Room
3182, 6701 Rockledge Drive, Bethesda,
MD 20892 or call non-toll-free number
(301) 435–1251 or Email your request,
including your address to: guadagma@
csr.nih.gov.
SUPPLEMENTARY INFORMATION: The
Center for Scientific Review (CSR),
National Institutes of Health, may not
conduct or sponsor, and the respondent
is not required to respond to, an
information collection that has been
extended, revised, or implemented on or
after October 1, 1995, unless it displays
a currently valid OMB control number.
In compliance with Section
3507(a)(1)(D) of the Paperwork
Reduction Act of 1995, the National
Institutes of Health (NIH) has submitted
to the Office of Management and Budget
(OMB) a request for review and
approval of the information collection
listed below.
Proposed Collection: Early Career
Reviewer Program Application and
Vetting System (EAVS) OMB #0925–
0695, Expiration Date: 04/30/2017,
Extension, Center for Scientific Review
(CSR), National Institutes of Health
(NIH).
Need and Use of Information
Collection: The Center for Scientific
Review (CSR) is the portal for NIH grant
applications and their review for
scientific merit. Our mission is to see
that NIH grant applications receive fair,
E:\FR\FM\28MRN1.SGM
28MRN1
Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
----------------------------------------------------------------------------------------------------------------
NIH Ref. No. Patent No. or application No. Filing date Title
----------------------------------------------------------------------------------------------------------------
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''.
----------------------------------------------------------------------------------------------------------------
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 shmilovm@mail.nih.gov.
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