[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:

----------------------------------------------------------------------------------------------------------------
           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 [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