Abbott's Next-Generation Epic Plus and Epic Plus Supra Bioprosthetic Heart Valves Receive NMPA Approval in China

# Valve Track

Valvular heart disease is a common heart condition in China, and with the aggravation of population aging, senile valvular disease...Valvular lesions caused by coronary heart disease and myocardial infarction are also becoming increasingly common.。If one or more of the heart's four valves cannot open or close properly, it will lead to valvular heart disease., thereby disrupting blood flow to the body, most commonly affecting the aortic and mitral valves.When diseased or damaged heart valves cannot be repaired, they can be surgically replaced with mechanical or biological (tissue) valves during open-heart surgery.。

Biological valves refer to artificial heart valves made from materials sourced from other animals' bodies, processed and treated accordingly.Its biggest advantageAbout 3-6 months after implantation in the human body, the surface of the valve leaflets will be covered by deposited fibrin and vascular endothelial tissue, and the valve material will no longer come into contact with the patient's blood.Avoid activating the blood coagulation reaction, thereforeAnticoagulation therapy will no longer be needed after 3-6 months.。

But the downside is，Bioprosthetic valves are prone to calcification, which can significantly alter the elasticity, toughness, and mechanical strength of the valve material., which makes the lifespan of bioprosthetic valves limited. With the increase in average life expectancy, an increasing number of patients who have undergone valve replacement surgeryFacing Secondary Valve ReplacementThe challenge.

A large clinical dataset (non-randomized study) encompassing 1,199 U.S. medical institutions compared the follow-up outcomes from 1991 to 2003 of 111,151 patients with aortic bioprosthetic valves and 195,903 patients with aortic mechanical valve replacements.The results showed,The incidence rates of death, re-intervention due to bleeding, stroke or embolism, and mortality associated with reoperation in bioprosthetic valve replacement are all lower than those in mechanical valve replacement.However, the proportion of reoperation due to valve failure is higher.。

Currently, new surgical bioprosthetic valves have also been adjusted to meet the potential future need for re-replacement surgeries. In the past, surgically implanted valves often featured a complete metallic annular support structure, which could pose a risk of not fitting during a subsequent TAVR procedure if the valve’s size was too small.New-style surgical valves can be set with notches on the original intact annular stent.，By expanding the stent, more space is created, facilitating the implantation of a second valve., ensuring sufficient transvalvular blood flow in the long term and leading to better patient outcomes.。

Moreover, as research continues to deepen,Polymeric material valves combine the advantages of both mechanical and bioprosthetic valves., which not only possesses excellent fatigue resistance but also better blood compatibility, is gradually appearing in clinical settings. The future innovations in the field of heart valves are worth our anticipation and attention.

# Product Introduction

In September 2021, Abbott announced that the FDA had approved the company's Epic Plus and Epic Plus Supra Tissue Valves.For patients who need to replace diseased, damaged, or malfunctioning native mitral valves, it can also be used to replace previously implanted artificial mitral valves.. These new-generation devicesBuilt on Abbott's Epic Surgical Valve Platform, which has decades of safety history and excellent clinical outcomes, including innovations in valve implantation and future cardiac interventions.

Epic Plus is a bioprosthetic valve that does not require long-term use of blood-thinning medications, thusIt is the recommended choice for people who cannot take blood thinners or those over 70 years old (populations with an increased risk of bleeding from such medications).。The platform has all valve sizes inMinimum Ventricular Prominence, a flexible polymer stent, individually selected porcine leaflets to ensure optimal integration, and a flexible suture cuff that minimizes suture resistance during implantation and paravalvular leakage after implantation.The Epic™ Plus valve is less prone to curling, whichCan reduce LVOT obstruction。

It is reported that the Epic Plus valve is designed toAdaptation of Valve-in-Valve Therapy，Make the patient free ofNeed to undergo a second open-heart surgeryCan enjoy the benefits of tissue valves。

One of the new features of the Epic Plus tissue valve isRadiopaque markers. The radiopaque markers enable the medical team to perform valve-in-valve procedures.Better observation and placement of transcatheter valves through X-rays。

▲Valve-in-Valve Procedure

Another new feature isThe Ability to "Fracture" Valves in Valve-in-Valve Surgery. The doctor can open the Epic Plus valve, so thatA larger valve can be implanted within the Epic Plus valve., to prevent the valve from being too narrow for normal flow.

To improve durability, the Epic Plus valve also enhances the valve tissue.Performed anti-calcification treatment to reduce calcium accumulation., based on Abbott's uniqueLinx AC Anti-Calcification Technology，By extracting lipids, reducing free aldehyde groups, minimizing cholesterol absorption, and stabilizing lobular collagen,To ensure its long-term performance and durability, possibly extending 10 to 15 years, or even longer.

In the subgroup aged ≤59 years,The proportion without structural valve degeneration (SVD) within 10 years is87.7%。Epic Plus ValveThe 10-year durability data of the membrane shows,The aorta is not affected by SVD.. In addition,Compared with similar products already on the market,Epic Plus ValveDemonstrates excellent hemodynamics。