Download this brochure for product details and information about the Mosaic Neo™ mitral bioprosthesis.
Tissue valves and conduits
Mosaic Neo™ mitral bioprosthesis
<p>The Mosaic Neo™ mitral bioprosthesis is a next-generation native porcine valve for mitral valve replacement.</p>
Features
- The atrialized design of the Mosaic Neo™ valve reduces left ventricular (LV) protrusion by up to 23% compared to the Mosaic™ mitral valve.6,7
- The native-porcine design offers one wider leaflet spaced at 135° — this wider interstrut distance between the anterior stent posts is designed to preserve the neo-LVOT and provide left ventricular outflow tract (LVOT) clearance.†,8–10
- Offers up to 40% reduced implant profile versus other commercially available tissue mitral valves.‡,11–13
- The Cinch™ implant system facilitates valve implantation particularly through tight patient anatomy and small incisions and helps prevent suture looping.14
- Cuff markings allow for a simple orientation of the valve’s largest leaflet towards the LVOT to enable LVOT clearance.6,15,16
- New holder with quick detach, single-cut handle removal mechanism eliminates the need to unscrew the handle, aiding with ease of implantation.15,16
Product details
Created for LVOT clearance
With the sewing cuff shifted towards the outflow of the valve, the Mosaic Neo™ mitral valve features an atrialized design that reduces stent post protrusion by up to 23% compared to the legacy Mosaic™ mitral bioprosthesis. In addition, the cuff markings allow for a simple orientation of the valve’s largest leaflet towards the outflow tract — all designed to preserve the neo-LVOT and enable LVOT clearance.6,7,15,16
The unique native-porcine valve design offers a wider interstrut distance at the anterior annulus, which may reduce the risk of LVOT obstruction.†,8–10
3-D patient model, native annulus diameter 30.8 mm, aorta-mitral-annular angel 120 degrees. Medtronic anatomical model D00807491_A 3D.
Proven to perform
Recent long-term studies have shown that the Mosaic™ native-porcine tissue valve demonstrates better durability outcomes in the mitral position than bovine pericardial tissue valves. A retrospective study compared the 17-year follow-up outcomes of the native-porcine Mosaic™ mitral valve to Carpentier-Edwards™* (CE) bovine pericardial mitral valves.2,3,17
Time to reopen for SVD§,3
Study design3
- Retrospective, observational, single-center study
- 463 Mosaic™ mitral porcine bioprosthesis
- 477 CE mitral pericardial bioprosthesis
(majority PERIMOUNT Magna™* mitral valve) - 401 of each valve were propensity matched
– Average age for Mosaic™ valve = 68.6 years
– Average age for PERIMOUNT Magna™* mitral valve = 67.7
Rate of reintervention for SVD3
- The rate of overall reoperation for pericardial valves is 1.89 (95% CI 1.13%–3.17%) times higher than that for porcine valves.
- The rate of reoperation due to SVD is 2.32 (95% CI 1.31–4.11) times higher in the pericardial valves versus the porcine valves.
On average, the time before reoperation for SVD was 4.3 years longer with Mosaic™ procine valves than Carpentier-Edwards™* pericardial valves.3
Enhanced for ease
The Mosaic Neo™ platform offers multiple enhancements designed to enable a straightforward mitral valve replacement procedure. Updated smooth barrel sizers, intuitive cuff markings, and a quick-detach handle release work together to simplify workflow — delivering a smoother implant experience from start to finish.
The new Mosaic Neo™ valve holder offers a quick-detach, single-cut handle release for a simplified implantation process.15,16
Pre-attached, smooth barrel sizers offer a simple mitral annular measurement.15,18
The Cinch™ implant system facilitates valve implantation particularly through tight patient anatomy and small incisions.14
Streamlined for minimally invasive
The new, lower implant profile Mosaic Neo™ valve offers a best-in-class implant profile for small incision surgery and is designed to give surgeons better access and greater procedural predictability — no matter the surgical approach.11–13,16
A. Mosaic Neo™ mitral valve
Size 29, implant profile height: 21.00 mm
B. MITRIS RESILIA™* mitral valve
Size 27, implant profile height: 26.00 mm
C. Epic™* Plus mitral valve
Size 29, implant profile height: 34.90 mm
Product features
Quick-detach handle release mechanism
Reduced stent post protrusion
Pre-attached, smooth barrel sizers
First-to-market small incision sizers
Clear cuff markers
Radiopaque inflow marker
Ordering information
| Order number | Valve size (stent O.D.◊) |
Orifice diameter (stent I.D.) |
Suture ring diameter | Valve height | Ventricular protrusion |
|---|---|---|---|---|---|
| 310MN25 | 25 | 22.5 | 33.5 | 18.0 | 11.0 |
| 310MN27 | 27 | 24.0 | 35.5 | 19.0 | 11.5 |
| 310MN29 | 29 | 38.0 | 38.0 | 20.5 | 12.5 |
| 310MN31 | 31 | 41.0 | 41.0 | 22.0 | 14.0 |
| 310MN33 | 33 | 43.5 | 43.5 | 23.0 | 14.5 |
| Item number | Description |
|---|---|
| 7639 | Handle (234 mm length), to be used with Mosaic™ and Mosaic Neo™ bioprostheses |
| 7639XL | XL Handle (368 mm length), to be used with Mosaic™ and Mosaic Neo™ bioprostheses |
| S310MNH | Mosaic Neo™ mitral sizers |
| T310MNH | Tray for Mosaic Neo™ mitral sizers |
| S310MNS | Mosaic Neo™ mitral small incision sizers |
| T310MNS | Tray for Mosaic Neo™ mitral small incision sizers |
TM* Third-party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.
† Bench test, may not be indicative of clinical performance.
‡ Dimensional measurements taken with Mosaic Neo™ valve size 29, Epic™* Plus size 29, MITRIS™* size 27 based on OD comparability.
§ SVD was defined, according to STS, as dysfunction or deterioration involving the operated valve, exclusive of infection or thrombosis, as determined by reoperation, autopsy, or clinical investigation. Mean follow-up times were significantly different (Mosaic™: 7.0 ± 4.8 versus Carpentier-Edwards™*: 6.0 ± 3.9, p = 0.002).
◊ Stent O.D. equivalent to annulus diameter.
- Riess FC, Cramer E, Hansen L, et al. Clinical results of the Medtronic Mosaic porcine bioprosthesis up to 13 years. Eur J Cardiothorac Surg. January 2010;37(1):145–153.
- Malvindi PG, Mastro F, Kowalewski M, et al. Durability of Mitral Valve Bioprostheses: A Meta-Analysis of Long-Term Follow-up Studies. Ann Thorac Surg. February 2020;109(2):603–611.
- Beute TJ, Goehler M, Parker J, et al. Long-Term Outcomes of Mosaic Versus Perimount Mitral Replacements: 17-Year Follow-Up of 940 Implants. Ann Thorac Surg. August 2020;110(2):508–515.
- Rieß FC, Fradet G, Lavoie A, Legget M. Long-Term Outcomes of the Mosaic Bioprosthesis. Ann Thorac Surg. March 2018;105(3):763–769.
- Tomšič A, Marin-Cuartas M, De La Cuesta M, et al. Clinical Outcomes After Mitral Valve Replacement With Epic and Mosaic Bioprosthetic Valves. Ann Thorac Surg Short Rep. December 21, 2023;2(2):251–256.
- M064035C001. Mosaic Neo Mitral Bioprosthesis Instructions for Use.
- Medtronic data on file. D01442020 Rev. A. Stent Post Protrusion Design Characterization Report.
- Medtronic data on file. D00807486 Rev. A. Valve Dimensional Measurements Report.
- Medtronic data on file. D00807491 Rev. A. Valve Anatomical Models.
- Brunel L, Williams ZA, Beijerink NJ, et al. Bioprosthetic interstrut distance subtending the preserved anterior mitral leaflet mitigates left ventricular outflow tract obstruction. JTCVS Open. May 21, 2021;8:251–258.
- Medtronic data on file. Report D01566568 Rev. A. Design Characterization Report.
- Medtronic data on file. Report D01576936 Rev. A. Design Characterization Report.
- Medtronic data on file. Report D01541798 Rev. A. Design Characterization Report.
- Takagi K, Arinaga K, Takaseya T, et al. Hemodynamic and clinical performance of the 25-mm Medtronic Mosaic porcine bioprosthesis in the mitral position. J Artif Organs. March 2022;25(1):34–41.
- Medtronic data on file. Mosaic Neo Mitral Bioprosthesis Claims Matrix, REF-33133. Design Validation Surgeon Survey.
- Medtronic data on file. D01187247 Rev. E. Design Description Document.
- Han DY, Park SJ, Kim HJ, et al. Bioprosthesis in the Mitral Position: Bovine Pericardial versus Porcine Xenograft. J Chest Surg. February 5, 2022;55(1):69–76.
- Medtronic data on file. D01433947 Rev. B, Attachment B. Design Validation Report.