[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]


-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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:

----------------------------------------------------------------------------------------------------------------
            NIH Ref No.               Patent application No.        Filing date                  Title
----------------------------------------------------------------------------------------------------------------
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.
----------------------------------------------------------------------------------------------------------------

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