In an interview with PharmaShots, Neil Moat, MD, DVP Medical Affairs, Chief Medical Officer at Abbott's shares his views on the Epic Plus Tissue Valves approval for the treatment of mitral or aortic valve replacement

• The US FDA has approved Epic Plus & Epic Plus Supra Stented Tissue Valves to improve therapy options for patients with aortic or mitral valve disease who undergoes valve replacement surgery without the need for blood thinner
• The devices have been developed using Abbott’s Epic surgical valve platform & can be implanted in the aortic or mitral valve position and patients with unique anatomies
• The new valves are designed to deliver performance and durability by using Abbott's anti calcification technology. The Epic Plus Mitral holder helps to ensure accurate implantation of the valve & has a lower profile for accurate placement during implantation

Tuba: Congratulations on the approval of Epic Plus and Epic Plus Supra Stented Tissue Valves. Can we talk about both of these products and how they function?

Neil Moat: The Epic Plus and Epic Plus Supra Stented Tissue Valves improve therapy options for people with heart valve disease. Used to replace diseased or damaged aortic or mitral heart valves that don't open or close properly, they help to restore the normal flow of blood into and out of the heart. These next-generation devices build off of Abbott’s well-established Epic surgical valve platform and include innovations that make valve implantation and future cardiac interventions easier.

The device can be implanted in the aortic or mitral valve position and patients with unique anatomies. Enhancements to the new devices include more radiopaque markers that make it easier for doctors to navigate if future transcatheter procedures are needed. In keeping with the Epic surgical valve platform, the new valves are designed to deliver long-term performance and durability due to Abbott's unique anti calcification technology.

The Epic Plus Mitral holder, which helps to ensure precise insertion of the valve, also has a lower profile so physicians have a better view of the device for accurate placement during implantation.

Tuba: What studies or trials is this approval based on? Can you elaborate on the study design and results?  

Neil Moat: Abbott’s Epic surgical valve platform has a decades-long history of safety and strong clinical outcomes. A study published in 2016 assessing 2,544 people receiving aortic, mitral, or double valve replacement with Epic over 10 years found that Epic was associated with large portions of people free from valve-related complications and valve reintervention for all older, in-coming patients.

These findings were encouraging and prompted a separate evaluation of Epic being used for mitral valve replacement, which examined the durability of Epic in the mitral position, according to patients’ ages at the surgery. Results from 482 mitral valve replacements with Epic showed good durability at five to 10 years in the mitral position and freedom from valve reintervention and no considerable influence of age at implantation as well.

Tuba: What are the target diseases Epic Plus and Epic Plus Supra treats?

Neil Moat: The Epic Plus Stented Tissue Valves are designed to help patients with heart valve disease who have more complex cases of aortic or mitral regurgitation or stenosis. Patients with heart valve disease can experience symptoms such as chest pain, palpitations, shortness of breath, fatigue, and fainting.

Bioprosthetic valves like Epic Plus do not require long-term use of blood-thinner medication, making them the recommended option for people who can't take blood thinners or are over 70 years of age (a group that has an increased bleeding risk from taking these medicines).

Tuba: What is the market size for Epic Plus and Epic Plus Supra?

Neil Moat: According to the American Heart Association, about five million Americans are diagnosed with heart valve disease each year. Heart valve disease most commonly impacts the aortic and mitral valves. More than 100,000 people in the U.S. have conventional heart valve surgeries with bioprosthetic (tissue) or mechanical valves each year, which are often life-saving procedures.

The Epic Plus Stented Tissue Valves are the latest addition to Abbott's portfolio of surgical tissue and mechanical heart valves. The company is also the global leader in mechanical heart valves with more than three million people treated worldwide.

Tuba: How are products like Epic Plus and Epic Plus Supra better than pharmaceutical drugs/ medications?

Neil Moat: Medication may be prescribed to treat heart valve disease symptoms and lessen the chance of further valve damage. When diseased or damaged heart valves can't be repaired, they may be surgically replaced with either mechanical or bioprosthetic (tissue) valves like the Epic Plus Stented Tissue Valves.

The approval of these valves provides an important treatment option for patients undergoing valve replacement surgery without the need for long-term blood thinners while providing a durable solution that allows for future cardiac interventions as needed. 

Tuba: When is Abbott expecting approval in the EU and other markets kindly specify?

Neil Moat: We are following the typical regulatory timelines once we’re able to submit our data for further evaluation in markets outside the U.S.

For years, doctors and their patients have depended on the durability and performance of the Epic valve platform, and we’re excited to be able to help improve the quality of life for more people around the world with heart valve disease.

Tuba: What other devices are in the pipeline for the heart disease business?

Neil Moat: 2021 has been a very exciting year for Abbott’s structural heart business, and in the past few months alone we've secured FDA approvals for not only Epic Plus, but also; our Amplatzer Amulet device, the first and only minimally invasive treatment option to offer immediate closure of the left atrial appendage in people with atrial fibrillation; the Amplatzer Talisman Occluder, offering the widest range of sizes for patent foramen (PFO) closure; and the Portico with FlexNav transcatheter aortic valve replacement (TAVR) system to treat people with aortic stenosis.

As we look to 2022 and beyond, we are constantly looking to develop new or improve our existing therapies that address structural heart diseases to help people live their fullest possible lives.

Source: Verywell Health

About Author: Neil Moat is the DVP Medical Affairs and chief medical officer at Abbott's. He has over 20 years previous experience as a Consultant Cardiac Surgeon and worked at The Royal Brompton Hospital, London. He holds MBBS from the St Mary's Hospital Medical School (IC - London University)

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