Blog Description

Product Review: Edwards Life Sciences SAPIEN 3 Ultra Transcatheter Heart Valve System

Healthcare | May, 2021

With aging, the valve’s leaflets stiffen and become clogged with calcium deposits and restrict blood flow from the heart to the rest of the body, and this condition is known as aortic stenosis. The life-threatening condition requires replacement of valves otherwise the patient could die within two years. Earlier open-heart surgery was the only standard available treatment option, but thanks to the introduction of transcatheter aortic valve replacement, or TAVR tools, now cardiologists can perform a minimally invasive and convenient procedure to replace calcific valves. Cardiologists are anticipating wider use of TAVR in the future due to refinements to both the devices and procedure itself, which does not require the administration of general anesthesia and thus makes the whole procedure comfortable and cost-effective for the patients. With two commercially available prostheses in the US, the Sapien family of valves, and the CoreValve device, the field of transcatheter aortic valve replacement continues to expand.

 

Recently, the global leader in patient-centric innovations for cardiovascular diseases, Edward Lifesciences announced that Sapien 3 Ultra System has received US FDA approval for transcatheter aortic valve replacement (TAVR) in patients with failing previously implanted transcatheter valve or with immediate or great risk of open-heart surgery. The Sapien 3 Ultra valve system is a modified version of the previously introduced catheter system by Edward Lifesciences, Sapien 3 valve. The latest iteration transcatheter valve features design enhancements and come with a new “on-balloon” expandable delivery system to address the needs of the patients as well as clinicians. The Sapien 3 Ultra system provides significant technological improvements adds simplicity and advances patient care by helping physicians optimize the transcatheter aortic valve replacement procedure. 

 

The Sapien 3 latest generation of balloon-expandable valves has a cobalt-chromium alloy frame to provide high radial strength for circularity and optimal hemodynamics. The valve tissue features three leaflets made from bovine pericardium in four different sizes of 20, 23, 26, and 29 mm with a heightened outer skirt designed to prevent paravalvular leak. Selection of appropriate size transcatheter heart valve should be made according to the treatable range of aortic annulus diameter, which ranges from 18.6 mm to 29.5 mm. The revamped 14-French delivery system can be used for all valve sizes, and the “on-balloon” design eliminates the valve alignment during the procedure. Modifications in the balloon system reduce the crossing profile for the device, so the balloon aortic valvuloplasty is often less required during the procedure. The new design allows most of the patients to undergo a “fully awake” aortic valve replacement procedure in less than 30 minutes and be safely discharged on the same day. 

 

How does the Sapien 3 Ultra Transcatheter Heart Valve System work?

The surgeon compresses Sapien 3 Ultra THV and places it on the end of a balloon catheter. The physician then moves the catheter with the mounted valve through the femoral artery, either in the leg or ribs. The transcatheter aortic valve is further pushed through the blood vessels with a hollow tube until it reaches the failing implanted transcatheter aortic valve. Then, the artificial valve is then expanded by a balloon and anchors, where it functions as the old valve to guide blood flow in the right direction. 

 

Not replacing the failing valve can lead to life-threatening heart problems like chest pain, irregular heart rhythm, heart failure, or cardiac arrest. The Sapien 3 Ultra THV can improve quality of life by replacing an existing failing catheter, however, the procedure to replace the aortic valve carries some complications, especially for patients with other serious medical conditions. The SAPIEN 3 Ultra THV System should not be used in patients who cannot tolerate blood-thinning medications as well as have an infection in the heart or elsewhere. 

 

The FDA-approved Sapien 3 Ultra TAVR system is considered the most preferred option for low-risk severe Aortic Stenosis patients as it is the only valve system to attain superiority over surgery based on the pre-specified primary endpoint. With stable and precise deployment delivering 99% first-time accuracy and dual articulation of coaxiality, the Edwards Commander Delivery system ensures predictable and proven results. A low-delivery profile and optimal position control offer predictable and proven results. Edwards eSheath Introducer Set features Dynamic Expansion Mechanism (DEM) for low-profile access to significantly reduce major vascular complications. The hydrophilic coating on the eSheath is designed for easy insertion and controlled deployment.

 

Despite advances in a transcatheter heart valve, Periventricular leukomalacia (PVL) remained a frequent complication after Transcatheter aortic valve implantation (TAVI), with much higher rates as compared with Surgical Anterior Ventricular Restoration (SAVR). The “next”-gen device is designed with special features such as repositionability and retrievability to allow a controlled deployment as well as external sealing features to overcome the risks of PVL after TAVI. Besides the technical developments, more sophisticated sizing algorithms also contribute to a reduction in PVL by an optimized valve deployment. Vascular complications such as aortic dissection, annular rupture, or left ventricular perforation used to be another major hurdle associated with TAVI procedures. However, mounting THV system onto the deployment balloon within the body in descending aorta for reduction of the delivery system profile led to a significant reduction in vascular complications, and ultimately result in low mortality and morbidity rates reduced hospital rates and decreased costs. With advances in S3 Sapien, the rate of cerebrovascular events has reduced after TAVI in recent years due to technical advances in THV technology and delivery systems. 

 

Competing Devices 

Generally, transcatheter heart valve systems are categorized based on deployment mechanisms such as balloon-expandable, self-expanding, or mechanically expanding. All the technologies have great efficacy and provides good clinical outcomes. Historically, mainly the SAPIEN and CoreValve THV families have ruled the valve replacement market, but nowadays other new THV designs have transcended, opening a lot of options for cardiologists. Self-expanding Boston Scientific ACURATE neo™, Abbott Portico™ as well as mechanically expanded Boston Scientific Lotus valve systems are some of the new THV devices that show almost the same clinical outcomes in high-risk patients, however, SAPIEN still has higher success rates when compared to new contenders. 

 

Medtronic CoreValve Evolut R system

Available in four sizes of 23, 26, 29, and 34 mm, the CoreValve Evolut R device enables the treatment of valves with a perimeter of 56.5-94.2 mm. Mounted and sutured within a self-expandable nitinol frame, the device has a high radial force that allows self-expansion and exclusion of native calcified valve leaflets. Evolut R design ensures recapturability and repositionability and its frame is tailored to reduce the overall height while preserving the height of the pericardial skirt (13mm) to provide a seal against PVR. 

 

St. Jude Medical Portico

Composed with a self-expanding stent, the portico valve consists of a porcine pericardial sealing cuff and bovine leaflets. The large cell area of the device allows easy engagement of the coronary Ostia after implantation and minimizes the risk of paravalvular leakage to conform around calcific nodules at the annulus. Available in four sizes, 23 mm, 25 mm, 27 mm, and 29 mm, the portico device can be delivered by transfemoral access. 

 

Boston Scientific Lotus Valve System 

Supported on a braided nitinol frame, the Lotus Valve System consists of a trileaflet bovine pericardial valve. Covered with an adaptive seal at the inflow segment, the frame adapts to aortic root irregularities and reduces the risk of paravalvular leak. The transcatheter heart valve is available in three sizes, 23, 25, and 27 mm, covering a range of annulus diameters from 19 to 27 mm. All sizes have a frame height of 19 mm in the fully deployed state and can be typically inserted through a transfemoral approach. It is the only new-generation TAVR device that allows recaptures and repositioning even after deployment. 

 

Symetis Acurate NEO 

The Acurate NEO aortic bioprosthesis flaps are made from porcine pericardium sewn onto a stent made of self-expanding nitinol. The device prosthesis can be implanted through both the transapical and transfemoral routes single simple two-step deployment and stable positioning. The Acurate Neo comes in different sizes, small, medium, and large. 

 

Conclusion

The field of transcatheter aortic valve replacement has evolved tremendously. The improvement in the valve design, patient selection, and valve sizing is reducing complications associated with the TAVR procedure. Over the last decade, the indication for TAVR devices has shifted from challenging intervention in high-risk patients to a standardized procedure in intermediate to low-risk patients. Currently, S3 Ultra is one of the widely used THVs in the field of TAVR due to its excellent outcomes and success rates. 

According to TechSci research report on “Global Interventional Cardiology Devices Market By Product Type (Angioplasty Balloons, Angioplasty Stents, Structural Heart Devices, Catheters, Plaque Modification Devices, Hemodynamic Flow Alteration Devices, Others) By End User (Hospitals & Clinics, Ambulatory Surgery Centers, Others) By Region, Competition Forecast & Opportunities, 2026”, the global interventional cardiology devices market is expected to grow at a steady rate in the coming years due to increasing number of heart related diseases as well as introduction of technological advancements in the medical devices.

According to another TechSci research report on “Global Stent Market By Type of Product (Vascular Stent (Coronary Vascular Stent, Peripheral Vascular Stent, Neurovascular Stent) and Non Vascular Stent), By Material (Metallic Biomaterial, Polymeric Biomaterial and Natural Biomaterials), By Type (Self-Expandable and Balloon-Expandable), By End User (Hospital & Clinics, Ambulatory Care Centers and Others) By Region, Competition, Forecast & Opportunities, 2026”, the global stent market is anticipated to grow at a steady rate due to spike in cardiovascular surgeries as well as growing adoption of minimally invasive techniques.




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