Millipede Percutaneous Annuloplasty Ring

Award Information
Agency:
Department of Health and Human Services
Branch
n/a
Amount:
$147,611.00
Award Year:
2010
Program:
SBIR
Phase:
Phase I
Contract:
1R43HL102961-01A1
Award Id:
96334
Agency Tracking Number:
HL102961
Solicitation Year:
n/a
Solicitation Topic Code:
NHLBI
Solicitation Number:
n/a
Small Business Information
MC3, INC., 3550 W LIBERTY RD, STE 3, ANN ARBOR, MI, 48103
Hubzone Owned:
N
Minority Owned:
N
Woman Owned:
N
Duns:
806687406
Principal Investigator:
BRIANBIANCUCCI
(734) 995-9089
BIANCUCCI@MC3CORP.COM
Business Contact:
OSTERHOLXERKATHRYN
() -
koster@mc3corp.com
Research Institute:
n/a
Abstract
DESCRIPTION (provided by applicant): Heart valve regurgitation is a serious condition related to heart disease. The most common and effective surgical method for treating this disease is with the use of an annuloplasty ring, which reduces the size of a dil ated valve annulus to restore normal function. Many patients do not receive this procedure, however, either because they are too sick to undergo open heart surgery, or their condition has not yet progressed to the point at which surgery is justified. To ad dress this large untreated patient population, many efforts have been undertaken to develop technology to repair leaky valves via catheter. Of these, the Millipede concept is the only device which can perform a true ring annuloplasty. This concept uses a r ing that can both expand and contract under a radial force and has many small barbed anchors around its perimeter. The ring is mounted on the proximal end of an expandable, cone- shaped delivery tool prior to delivery. The collapsed dilator-ring assembly i s advanced toward the annulus and the apex of the cone is pushed through the valve orifice. The cone is then expanded, which simultaneously expands the ring to a known diameter and forces the annulus into a circular shape with the same diameter, resulting in automatic alignment of the ring and the annulus. Once aligned, a simple forward push of the delivery tool drives the barbed anchors into the tissue and secures the ring in place. The dilator tool is then contracted down and removed. In Phase I of this p roject we will build functional prototypes of the ring and delivery tool and test their performance on the benchtop in pig hearts. In Phase II we will further develop this device and conduct testing necessary to achieve regulatory approval for surgical use . Also in Phase II, we will develop the delivery system needed to implant the device percutaneously. PUBLIC HEALTH RELEVANCE: The goal of this project is to develop a sutureless annuloplasty ring for the treatment of dilated, leaking heart valves. T his will lead to an annuloplasty ring that can be implanted without surgery, which will benefit a significant number of patients who have valve disease but are not candidates for surgery.

* information listed above is at the time of submission.

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