- In Breakthrough Technology
- Post 26 January 2012
- By Sundeep Mishra
- Hits: 1458
St Jude Trifecta Valve Approved by DCGI
Trifecta is the next-generation pericardial tissue heart valveâ€“and perfect complementâ€“to the line of tissue valves from St. Jude Medical that includes Epicâ„¢ and Biocorâ„¢. The Trifecta valve is a stented tissue heart valve with exceptional in vivo mean gradients across all valve sizes.1 The unique valve design includes pericardial tissue leaflets attached to the exterior of the valve stent allowing it to open more fully and efficiently to perform like a natural heart valve.
The Trifecta valve has been specifically designed for excellent hemodynamic performance, durability and implantability.
Created exclusively for the aortic position, the Trifecta valve delivers larger EOAs, resulting in single-digit pressure gradients.1 The Trifecta valve is designed to mimic the flow of a natural, healthy heart valve and offers excellent hemodynamic performance, which may provide patients with an improved quality of life.
In vivo single-digit mean gradients averaged across all valve sizes at six months.1
Large EOAs across all valve sizes result in decreased risk of patient-prosthesis mismatch at six months.1
The Trifecta valve is designed for long-term durability and performance. The result is a design that has demonstrated excellent in vitro wear testing.2
1. Pericardial covered stent for tissue-to-tissue contact reducing the risk of abrasion and structural valve deterioration.2
2. Elimination of tacking suture at top of commissure reduces risk of tearing.
3. Proper leaflet shaping and coaptation are achieved through proprietary tissue leaflet fixation.2
4. Leaflets from a single pericardial sheet, externally mounted, optimize coaptation and maximize flow.
Fatigue-resistant, high-strength titanium stent designed to reduce stress on leaflets during cardiac cycle.2
The Trifecta valve offers superior hemodynamic performance1 with the implantability of a stented valve, accommodating a surgeon's existing implantation technique.
- Contoured silicone insert within a unique polyester cuff is designed to conform to the shape of the native annulus for proper seating and to reduce the risk of PV leak.1
- Trifecta valve sizers are optimized for true-to-size selection.
- Efficient 2 x 10-second rinse.
- Aortic valve holder improves visibility and cuff access for suturing.
- Both the flexible and rigid valve holder handles provide quick, click-in handle attachment and removal to stabilize the valve and minimize the risk of unseating.
1. St. Jude Medical. Trifecta Valve, Pre-Market Approval Application Summary of Safety and Effectiveness Data, P100029, 2011.
2. Data on File, St. Jude Medical.
Indications, Contraindications, Warnings, Precautions & Potential Adverse Events
Indications For Use
The Trifecta Valve is intended as a replacement for a diseased, damaged, or malfunctioning aortic heart valve. The Trifecta Valve may also be used as a replacement for a previously implanted aortic prosthetic heart valve.
- For single use only.
- Do not resterilize the valve by any method.
- Valve size selection is based on the size of the recipient annulus and the anatomy of the sinotubular junction. Implantation of an inappropriately large bioprosthesis may result in stent deformation, valvular incompetence, and/or damage to the surrounding tissues. Do not oversize the valve. If the native annulus measurement falls between two Trifecta Valve sizes, use the smaller size Trifecta Valve. Use only the Model TF-1000 or TF2000 Trifecta Valve Sizer Set for sizing a Trifecta Valve.
- Passage of a catheter or transvenous pacing lead through any bioprosthesis may damage the valve and is therefore not recommended.
- Accelerated deterioration due to calcific degeneration of the Trifecta Valve may occur in:
- Children, adolescents, or young adults
- Patients with altered calcium metabolism (e.g., patients with hyperparathyroidism or chronic renal failure)
- Individuals requiring hemodialysis
- The titanium valve stent is not designed as a flexible stent. Do not bend the titanium valve stent. Deformation of the stent may impair valve function.
Do not use if:
- The valve has been dropped, damaged, or mishandled in any way, or if there is any sign of deterioration.
- The expiration date has elapsed.
- The tamper-evident container seal is damaged, broken, or missing, or if fluid is leaking from the packaging.
- The storage solution does not completely cover the valve.
- Sizers are supplied non-sterile, and must be cleaned and sterilized prior to each use. Do not use cracked, crazed, or deformed sizer set components.
- Do not pass the flanged portion of the TF-1000 sizer through the annulus when sizing the valve.
- Do not pass the replica end of the TF2000 sizer through the annulus when sizing the valve
- Position the valve so that the stent posts do not obstruct the coronary ostia.
- Do not place the non-sterile exterior of the valve container in the sterile field.
- Do not expose the valve to solutions other than the formaldehyde solution in which it was shipped, the sterile isotonic saline solution used during the rinsing procedure, or the sterile isotonic saline used to irrigate the valve.
- Do not add antibiotics to either the valve storage solution or the rinse solution.
- Do not apply antibiotics to the valve.
- Do not allow the valve tissue to dry. Place the valve in isotonic sterile saline rinse solution immediately upon removal from the valve storage solution. Once removed from this solution, the valve should be periodically irrigated during implantation.
- Do not use the valve if shipping temperature indicators on the product carton have turned red, or if the valve has been improperly stored in temperature conditions outside of the 5Â°C-25Â°C (41Â°F to 77Â°F) range.
- Do not implant the valve without thoroughly rinsing as directed.
- Use caution when placing sutures through the sewing cuff to avoid lacerating the valve tissue. If a valve is damaged, the valve must be replaced.
- Do not attempt to repair a valve. Damaged valves must not be used.
- Do not use cutting edge needles, unprotected forceps, or sharp instruments, as they may cause structural damage to the valve.
- Use caution when tying knots to avoid bending the stent posts.
- Never handle the leaflet tissue.
- Avoid prolonged contact with the formaldehyde storage solution. Immediately after contact, thoroughly flush any skin exposed to the solution with water. In case of contact with eyes, flush with water and seek appropriate medical care.
MRI Safety Information
Non-clinical testing has demonstrated that the Trifecta Valve is MR conditional. It can be scanned safely under the following conditions:
- Static magnetic field of 3 Tesla or less
- Spatial gradient of 525 Gauss/cm or less
- Maximum whole-body-averaged specific absorption rate (SAR) of 2.0-W/kg for 15 minutes of scanning.
In non-clinical testing, the Trifecta Valve produced a temperature rise of less than or equal to 0.5Â°C at a maximum whole body averaged specific absorption rate (SAR) of 2.0 W/kg for 15 minutes of MR scanning in a 3-Tesla Signa model (GE) MR scanner. MR image quality may be compromised if the area of interest is the exact same area or relatively close to the position of the bioprosthesis.
Potential Adverse Events
Adverse events potentially associated with the use of bioprosthetic heart valves (in alphabetical order) include:
- cardiac arrhythmias
- heart failure
- hemolytic anemia
- leak, transvalvular or paravalvular
- myocardial infarction
- nonstructural dysfunction (entrapment by pannus or suture, inappropriate sizing or positioning, or other)
- prosthesis regurgitation
- structural deterioration (calcification, leaflet tear, or other)
- valve thrombosis
It is possible that these complications could lead to:
- permanent disability