82 FR 15363 - Prospective Grant of an Exclusive Patent License for Commercialization: Cerclage Annuloplasty Devices for Treating Mitral Valve Regurgitation
DEPARTMENT OF HEALTH AND HUMAN SERVICES
National Institutes of Health Federal Register Volume 82, Issue 58 (March 28, 2017)
National Institutes of Health
Federal Register Volume 82, Issue 58 (March 28, 2017)
| Page Range | 15363-15364 | |
| FR Document | 2017-06036 |
[Federal Register Volume 82, Number 58 (Tuesday, March 28, 2017)] [Notices] [Pages 15363-15364] From the Federal Register Online [www.thefederalregister.org] [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 [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
![Federal Register / Vol. 82, No. 58 / Tuesday, March 28, 2017 / Notices 15363
Name of Committee: National Cancer Rockville, MD 20850, (240) 276–5683, DEPARTMENT OF HEALTH AND
Institute Special Emphasis Panel; Feb2017 toby.hecht2@nih.gov. HUMAN SERVICES
Cycle 25 NExT SEP Committee Meeting. (Catalogue of Federal Domestic Assistance
Date: April 19, 2017. National Institutes of Health
Program Nos. 93.392, Cancer Construction;
Time: 8:30 a.m. to 4:30 p.m.
Agenda: To evaluate the NCI Experimental 93.393, Cancer Cause and Prevention
Research; 93.394, Cancer Detection and Prospective Grant of an Exclusive
Therapeutics Program Portfolio.
Diagnosis Research; 93.395, Cancer Patent License for Commercialization:
Place: National Institutes of Health, 9000
Rockville Pike, Building 31, Wing C; 6th Treatment Research; 93.396, Cancer Biology Cerclage Annuloplasty Devices for
Floor, Conference Room 10, Bethesda, MD Research; 93.397, Cancer Centers Support; Treating Mitral Valve Regurgitation
20892. 93.398, Cancer Research Manpower; 93.399,
Contact Person: Barbara Mroczkowski, Cancer Control, National Institutes of Health, AGENCY: National Institutes of Health,
Ph.D., Executive Secretary, Discovery HHS) HHS.
Experimental Therapeutics Program, ACTION: Notice.
National Cancer Institute, NIH, 31 Center Dated: March 22, 2017.
Drive, Room 3A44, Bethesda, MD 20817, Melanie J. Pantoja,
(301) 496–4291, mroczkoskib@mail.nih.gov. SUMMARY: The National Institutes of
Program Analyst, Office of Federal Advisory Health (NIH), Department of Health and
Toby Hecht, Ph.D., Executive Secretary, Committee Policy.
Development Experimental Therapeutics Human Services, is contemplating the
Program, National Cancer Institute, NIH, [FR Doc. 2017–06040 Filed 3–27–17; 8:45 am] grant of a worldwide exclusive license
9609 Medical Center Drive, Room 3W110, BILLING CODE 4140–01–P to practice the inventions embodied in:
Patent No. or
NIH Ref. No. Filing date Title
application No.
E–249–2006/0–US–01 .......... 60/858,716 November 14, 2006 ............. A Device To Protect Coronary Arteries Against Compres-
sion 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 Pro-
tection 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 Protec-
tion Device with ‘‘Landing Zone’’.
to Transmural Systems, LLC, a limited disorders, with an estimated prevalence normal MV, resulting in secondary MR.
liability company incorporated under of approximately 1.7% in the United Specifically, LV dysfunction and
the laws of the State of Massachusetts States, increasing with age to remodeling lead to apical and lateral
and having its principle place of approximately 9.3% in those over the papillary muscle displacement,
business in Andover, Massachusetts. age of 75. MR is classified as primary resulting in leaflet tethering, dilation
The contemplated exclusive license may (also known as ‘‘organic’’) when and flattening of the mitral annulus, and
be limited to cerclage annuloplasty principally due to a structural or reduced valve closing forces.
devices for treating mitral valve degenerative abnormality of the mitral The subject mitral repair system
regurgitation. valve (MV), whether of the leaflets, devices are primarily intended to treat
chordae tendineae, papillary muscles, or secondary mitral regurgitation. The
DATES: Only written comments and/or
mitral annulus. Secondary (also known proposed mitral cerclage with coronary
applications for a license that are
as functional) MR occurs in the absence artery protection is an approach capable
received by NIH at the address indicated
of organic MV disease, usually from left of overcoming many of the problems
below on or before April 12, 2017 will
ventricular (LV) dysfunction. It is more that exist with existing devices namely
be considered.
common than primary MR and is allowing a larger subset of patients to be
ADDRESSES: Requests for a copy of any associated with a worse prognosis treated compared to other coronary
unpublished patent application, (compounded by the underlying sinus devices, providing a full
inquiries, objections to this notice, cardiomyopathy), and (in contrast to annuloplasty type device which is
comments and other requests relating to primary MR) the benefits of MV surgery flexible enough to preserve annular
the contemplated license should be are uncertain. The MV consists of two motion, reduce hospitalization costs and
directed to: Michael Shmilovich, Esq., leaflets (anterior and posterior) sitting shorten recovery time. The associated
CLP, Senior Licensing and Patent within the annulus (see picture below). method closely resembles the surgical
Manager, 31 Center Drive Room 4A29, The posterior mitral leaflet originates placement of a full annuloplasty ring.
MSC2479, Bethesda, MD 20892–2479, from the left atrial (LA) endocardium. A
phone number 301–435–5019, or subvalvular apparatus, comprising two E–249–2009/0–2
sradovich on DSK3GMQ082PROD with NOTICES
shmilovm@mail.nih.gov. papillary muscles (anterolateral and Catheter-based mitral valve
SUPPLEMENTARY INFORMATION: This posteromedial) arising from the LV regurgitation treatments that use
notice is published in accordance with myocardium and the chordae tendineae, coronary sinus trajectory or coronary
35 U.S.C. 209(c)(1) and 37 CFR supports the leaflets. LV dilation due to sinus implant can have unwanted
404.7(a)(1)(i). ischemic or nonischemic effects because the coronary sinus and
Mitral regurgitation (MR) is amongst cardiomyopathy secondarily impairs its branches have been found to cross
the most common valvular heart leaflet coaptation of a structurally the outer diameter of major coronary
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![15364 Federal Register / Vol. 82, No. 58 / Tuesday, March 28, 2017 / Notices
arteries in a majority of humans. As a mechanical ‘‘landing zone’’ for mitral and Budget (OMB) a request for review
result, pressure applied by any valve implantation. A cerclage and approval of the information
prosthetic device in the coronary sinus annuloplasty ring would allow outward collection listed below. This proposed
(such as tension on the annuloplasty expansion of the mitral valve to achieve information collection was previously
device) can compress the underlying fixation. However, without the cerclage published in the Federal Register on
coronary artery and induce myocardial protection device in place, such a December 29, 2016, page 96020 (Vol. 81,
ischemia or infarction. This invention strategy would cause compression of an No. 250) and allowed 60 days for public
pertains to devices and methods that entrapped coronary artery. This new comment. No public comments were
avoid constricting coronary artery embodiment of the protection device received. The purpose of this notice is
branches during coronary sinus-based protects coronary arteries not from to allow an additional 30 days for public
annuloplasty. These devices and extrinsic compression but from ‘‘inside- comment.
methods protect coronary artery out’’ compression, thereby allowing DATES: Comments regarding this
branches from constriction during trans- cerclage to be the first step for information collection are best assured
sinus mitral annuloplasty. The device transcatheter mitral valve implantation. of having their full effect if received
protects a coronary vessel from It also allows the latter to be employed within 30-days of the date of this
compression during mitral annuloplasty as second-stage adjunct or bailout for publication.
by extending an annuloplasty element, inadequate cerclage mitral valve ADDRESSES: Written comments and/or
such as a tensioning device, at least annuoplasty. suggestions regarding the item(s)
partially through the coronary sinus The prospective exclusive license will contained in this notice, especially
over a coronary artery. The device is a be royalty bearing and will comply with regarding the estimated public burden
surgically sterile bridge configured for the terms and conditions of 35 U.S.C. and associated response time, should be
placement within the coronary sinus at 209 and 37 CFR 404.7. The prospective directed to the: Office of Management
a location where the coronary sinus exclusive license may be granted unless, and Budget, Office of Regulatory Affairs,
passes over a coronary artery, so that the within fifteen (15) days from the date of OIRA_submission@omb.eop.gov or by
protection device provides a support for this published notice, NIH receives fax to 202–395–6974, Attention: Desk
a mitral annuloplasty element, such as written evidence and argument that Officer for NIH.
a compressive prosthesis, including a establishes that the grant of the license FOR FURTHER INFORMATION CONTACT: To
tension element when it is placed under would not be consistent with the
tension. The protection device has an request more information on the
requirements of 35 U.S.C. 209 and 37 proposed project or to obtain a copy of
arch of sufficient rigidity and CFR 404.7.
dimensions to support the tensioning the data collection plans and
Properly filed competing applications instruments, contact: Dr. Mary Ann
element over the coronary artery, for a license filed in response to this
redistribute tension away from an Guadagno, Project Clearance Liaison,
notice will be treated as objections to Center for Scientific Review, NIH, Room
underlying coronary artery, and inhibit the contemplated license. Comments
application of pressure to the 3182, 6701 Rockledge Drive, Bethesda,
and objections submitted in response to MD 20892 or call non-toll-free number
underlying artery, for example when an this notice will not be made available
annuloplasty tension element is placed (301) 435–1251 or Email your request,
for public inspection, and, to the extent including your address to: guadagma@
under tension during mitral permitted by law, will not be released
annuloplasty. In particular, the csr.nih.gov.
under the Freedom of Information Act,
protective device can be a support SUPPLEMENTARY INFORMATION: The
5 U.S.C. 552.
interposed in the coronary sinus Center for Scientific Review (CSR),
between the annuloplasty device and Dated: March 17, 2017. National Institutes of Health, may not
the coronary artery. The device may be Michael Shmilovich, conduct or sponsor, and the respondent
substantially tubular so that the Senior Licensing and Patenting Manager, is not required to respond to, an
tensioning element is contained within Office of Technology Transfer and information collection that has been
the protective device and supported in Development, National Heart, Lung, and extended, revised, or implemented on or
Blood Institute. after October 1, 1995, unless it displays
spaced relationship to the coronary
artery. An arch may be configured to [FR Doc. 2017–06036 Filed 3–27–17; 8:45 am] a currently valid OMB control number.
extend between a proximal end and a BILLING CODE 4140–01–P In compliance with Section
distal end that are substantially 3507(a)(1)(D) of the Paperwork
collinear with one another so that the Reduction Act of 1995, the National
ends form stabilizing members such as DEPARTMENT OF HEALTH AND Institutes of Health (NIH) has submitted
feet that retain the bridge in position HUMAN SERVICES to the Office of Management and Budget
over the coronary artery. (OMB) a request for review and
National Institutes of Health approval of the information collection
E–249–2009/3 listed below.
Submission for OMB Review; 30-Day
Another embodiment of the cerclage Proposed Collection: Early Career
Comment Request; Early Career
protection device is a combination with Reviewer Program Application and
Reviewer Program Application and
a cerclage tension element that can be Vetting System (EAVS) OMB #0925–
Vetting System (EAVS) (Center for
used to facilitate transcatheter mitral 0695, Expiration Date: 04/30/2017,
Scientific Review)
valve implantation. The transcatheter Extension, Center for Scientific Review
strategy includes a ‘‘valve-in-ring’’
sradovich on DSK3GMQ082PROD with NOTICES
AGENCY: National Institutes of Health, (CSR), National Institutes of Health
wherein a cerclage annuloplasty is first HHS. (NIH).
performed. During the same session or ACTION: Notice. Need and Use of Information
during a separate procedure, a Collection: The Center for Scientific
transcatheter mitral valve implantation SUMMARY: In compliance with the Review (CSR) is the portal for NIH grant
could be performed that would take Paperwork Reduction Act of 1995, the applications and their review for
advantage of the cerclage annuloplasty National Institutes of Health (NIH) has scientific merit. Our mission is to see
system to serve as a visual and a submitted to the Office of Management that NIH grant applications receive fair,
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Document Created: 2017-03-28 00:32:00
Document Modified: 2017-03-28 00:32:00
| Category | Regulatory Information | |
| Collection | Federal Register | |
| sudoc Class | AE 2.7: GS 4.107: AE 2.106: | |
| Publisher | Office of the Federal Register, National Archives and Records Administration | |
| Section | Notices | |
| Action | Notice. | |
| Dates | Only written comments and/or applications for a license that are | |
| FR Citation | 82 FR 15363 |
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