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CARBOMEDICS CARBOSEALTM

CARBOMEDICS CARBOSEAL VALSALVATM

Ascending aortic prostheses

Flexibility, handling and natural shape to coexist in a better way with nature

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CARBOMEDICS CARBOSEAL

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SPECIFICATIONS AND ORDERING INFORMATION

CatalogNumber

ValveSize

ValveOrifice Area

(cm2)

Graft Inner Diameter

(mm)

MinimumGraft Length

(cm)

AP-021 21 2.07 24 10

AP-023 23 2.56 26 10

AP-025 25 3.16 28 10

AP-027 27 3.84 30 10

AP-029 29 4.44 32 10

AP-031 31 4.44 34 10

AP-033 33 4.44 34 10

CARBOMEDICS CARBOSEALTM

Ascending aortic prostheses

TMCARBOMEDICS CARBOSEAL

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Unparalleled Flexibilityand Handling

Carbomedics Carbo-Seal AAP includes the Carbomedics Standard Aortic Valve, a fully rotatable valve with unsurpassed thromboembolic performance, excellent hemodynamics, and NO post-operative structural failures.

Thinner, more pliable, woven polyester from Vascutek®

requires no pre-clotting.

Easier handling and suturing in comparison to bulkier velour materials.

Gelweave's tissue-like flexibility allows for easy contouring.

Ultra-low porosity fabric results in less leakage, weeping and blushing.

Resists fraying and minimizes suture hole bleeding.

Orientation reference lines help in suture placement and graft-graft anastomosis.

Floating yarns provide a solid anchor for the fibrous tissue, preventing intimal peel

CARBOMEDICS CARBO-SEAL AAP USES GELWEAVE™ GRAFT

SPECIFICATIONS AND ORDERING INFORMATION

CatalogNumber

ValveSize

ValveOrifice Area

(cm2)

GraftInner Diameter

(mm)

Maximum SinusInner Diameter

(mm)

Sinus RegionLength*

(mm)

MinimumGraft Length

(cm)

CP-021 21 2.07 24 32 24 10

CP-023 23 2.56 26 34 26 10

CP-025 25 3.16 28 36 28 10

CP-027 27 3.84 30 38 30 10

CP-029 29 4.44 32 40 32 10

* Based on cadaveric anatomic studies, it was determined that the length of the sinus region should equal the bore diameter of the straight portion of the graft.

30 YEARS OF EXPERIENCE IN MECHANICAL HEART VALVES Carbomedics Carbo-Seal Valsalva AAP includes the Carbomedics Standard Aortic Valve, a fully rotatable valve with unsurpassed thromboembolic performance and excellent hemodynamics. Implanted over 20 years without a single post-operative stuctural failure.

TMCARBOMEDICS CARBOSEAL VALSALVA

CARBOMEDICS CARBOSEAL VALSALVATM

Ascending aortic prostheses

SINUS OF VALSALVA Vertical orientation of pleats facilitates

coronary anastomosis.

Replicates the native sinus, reducing stress on the coronary anastomoses.

Sinus design encourages natural formation of systolic vortex.

A better way to coexist with nature

Natural blood flow

Replicated Sinus of Valsalva.

Low profile taper to reduce stress on the coronary ostia buttons.

Sealed graft with no pre-clotting requirements.

Full-sized rotatable valve that maximizes the valve orifice to annulus ratio.

Pre-sterilized, disposable cautery unit supplied with every conduit.

Carbomedics Carbo-Seal AAP’s Gelweave™ graft is infused with minimally cross-linked gelatin instead of collagen for faster healing, encouraging a secure neo-intimal attachment with reduced inflammatory response**.

At one month, this light micrograph shows the formation of a smooth interluminal surface (top) with newly formed collagen

and endothelial cells.

**Data on file at LivaNova

GELATIN PROMOTES NATURAL HEALING

CARBOMEDICS CARBOSEAL VALSALVATM

First to feature

Carbomedics Carbo-Seal and Carbomedics Carbo-Seal Valsalva AAP come on a holder assembly to facilitate initial proximal placement.

Disposable cautery included inside every implant packaging.

Dual-ended, flexible annular sizers.

Valve rotator.

Disposable leaflet tester.

USER FRIENDLY INSTRUMENTATION

% Sealant Remaining

Gelatin Sealant

Collagen

100

80

60

40

20

0

0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15Days

Unlike collagen-coated grafts whichare enzymatically metabolized,the Carbomedics Carbo-Seal’s gelatin sealant is biodegraded by hydrolysisand rapidly absorbed within 14 days.

TMCARBOMEDICS CARBOSEAL VALSALVA

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RESULTS OF A NEW MECHANICAL VALVED CONDUIT WITH SINUSES OF VALSALVAJ.J. Appoo, A. Pochettino, K.F. Cornelius, J.E. Bavaria.Hospital of the University of Pennsylvania, Philadelphia, Pennsylvania, United States.Presented at the Biennial Meeting of the Society of Heart Valve Disease, June 2005

OBJECTIVES We describe our experience with a new mechanical valved conduit, the Carbomedics Sinus of Valsalva composite graft. It is the only composite graft on the market manufactured with sinuses of Valsalva. The presence of the sinuses of Valsalva allow for less extensive coronary mobilization especially in redo situations.

METHODS Review of prospectively collected data on patients undergoing composite mechanical valve replacement from December 2002 to September 2004.

RESULTS 64 patients were identified. Indications for operation included: ascending aortic aneurysm (87.5%), infective endocarditis (18.8%), and acute Type A dissection (10.9%). Twenty patients (31.2%) required a 2nd or 3rd time sternotomy. Concomitant procedures included arch replacement in 60.9%, mitral valve procedure in 9.4%, and CABG in 14.1%. Mean CPB, aortic cross clamp and DHCA times were: 242±77 mins,193±66 mins and 26±11 mins respectively. Periop mortality was 3.1% (n=2). The incidence of bleeding requiring mediastinal re-exploration was 1.6% (n=1). The incidence of stroke was 4.7% (n=3). All patients with CVA underwent an arch reconstruction and 2 of the 3 stroke patients presented with acute Type A dissection. None of the patients required reoperation for valve dysfunction.

CONCLUSIONS Despite the degree of complexity of operations in this study, this valved conduit is a very acceptable prosthesis for a modified Bentall procedure. It can be used for a variety of aortic pathology, both electively and in emergent settings. Due to the technical advantages the sinuses confer, it has become our valved conduit of choice when a mechanical prosthesis is chosen for aortic root replacement.

CARBOMEDICS CARBO-SEAL AND CARBOMEDICS CARBO-SEAL VALSALVA CLINICAL STUDIESCarbomedics Carbo-SealP. Urbanski, M. Wagner, M. Zacher, R.W. Hacker AORTIC ROOT REPLACEMENT VERSUS AORTIC VALVE REPLACEMENT: A CASE-MATCH STUDY Ann Thorac Surg 2001;72(1):28-32

G.B. Luciani, G. Casali, L. Barozzi, A. Mazzucco AORTIC ROOT REPLACEMENT WITH THE CARBOMEDCS CARBO-SEAL COMPOSITE GRAFT: 7-YEAR EXPERIENCE WITH THE FIRST 100 IMPLANTS Ann Thorac Surg 1999;68(6):2258-62

S. Langley, S. Rooney, M. Dalrymple-Hay, J. Spencer, M. Lewis, D. Pagano, M. Asif, J. Goddard, V. Tsang, R. Lamb, J. Monro, S. Livesey, R. Bonser REPLACEMENT OF THE PROXIMAL AORTA AND AORTIC VALVE USING A COMPOSITE BILEAFLET PROSTHESIS AND GELATIN-IMPREGNATED POLYESTER GRAFT (CARBO-SEAL): EARLY RESULTS IN 143 PATIENTSJ Thorac Cardiovasc Surg 1999;118:1014-20

Carbomedics Carbo-Seal ValsalvaR. De Paulis, G.M. De Matteis, P. Nardi, R. Scaffa, D.F. Colella, C. Bassano, F. Tomai, L. Chiariello - ONE YEAR APPRAISAL OF A NEW AORTIC ROOT CONDUIT WITH SINUSES OF VALSALVA - J Thoracic and Cardiovascular Surgery 2002;123 (1):33-39

R. De Paulis, G.M. De Matteis, P. Nardi, R. Scaffa, C. Bassano, L. Chiariello ANALYSIS OF VALVE MOTION AFTER THE REIMPLANTATION TYPE OF VALVE-SPARING PROCEDURE (DAVID I) WITH A NEW AORTIC ROOT CONDUIT - Ann Thorac Surg 2002;74:53-57

R. De Paulis, G.M. De Matteis, P. Nardi, R. Scaffa, M.M. Buratta, L. Chiariello OPENING AND CLOSING CHARACTERISTICS OF THE AORTIC VALVE AFTER VALVE-SPARING PROCEDURE USING A NEW AORTIC ROOT CONDUIT - Ann Thorac Surg 2001;72:487-494

R. De Paulis, G.M. De Matteis, P. Nardi, R. Scaffa, D.F. Colella, L. Chiariello RESEARCH METHOD AND NEW THERAPIES A NEW AORTIC DACRON CONDUIT FOR SURGICAL TREATMENT OF AORTIC ROOT PATHOLOGY - Ital Heart J 2000; 1 (7):457-463

Manufactured by:

Sorin Group Italia SrlA wholly-owned subsidiary of LivaNova PLCVia Crescentino13040 Saluggia (VC) ItaliaTel +39 0161 487472 - Fax +39 0161 487316info.cardiacsurgery@livanova.com

www.livanova.com

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Please always refer to the Instructions For Use (IFU) manual provided with each product for detailed information, warnings, precautions and possible adverse side effects.

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