{"id":24947,"date":"2018-08-09T08:04:27","date_gmt":"2018-08-09T13:04:27","guid":{"rendered":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/?p=24947"},"modified":"2025-05-09T08:40:08","modified_gmt":"2025-05-09T13:40:08","slug":"inspiris-resilia-fda-approval","status":"publish","type":"post","link":"https:\/\/www.heart-valve-surgery.com\/heart-surgery-blog\/2018\/08\/09\/inspiris-resilia-fda-approval\/","title":{"rendered":"Breakthrough Discovery: INSPIRIS RESILIA Aortic Valve Approved by the FDA"},"content":{"rendered":"

In case you missed it\u2026 \u00a0The INSPIRIS RESILIA<\/a> heart valve is now available in the United States. \u00a0This is an important development for patients who require a more resilient tissue valve for the replacement of their native or prosthetic aortic valve.^<\/p>\n

This revolutionary aortic valve (pictured below) is the first in a new class of so-called resilient heart valves introduced by Edwards Lifesciences. \u00a0It has a new tissue that is better at blocking calcium and a first of its kind expandable valve frame designed for potential future valve-in-valve procedures.*^ \u00a0And it is built on the proven Carpentier-Edwards PERIMOUNT valve design \u2013 which has helped over one million patients worldwide.<\/p>\n

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To educate our community about this new valve \u2013 which took 12 years to develop \u2013 I interviewed Dr. Lars Svensson<\/a>, Chairman of the Heart & Vascular Institute at the Cleveland Clinic<\/a>, and a world-renowned heart valve specialist. \u00a0Dr. Svensson was Co-Principal Investigator for the COMMENCE trial that evaluated this new RESILIA tissue technology.<\/p>\n

So you know, Dr. Svensson has successfully treated many patients in our community including Connie Taylor, Katherine Wardle and Daniel Conrad.<\/p>\n

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Dr. Lars Svensson<\/p>\n

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Why is the FDA approval of the INSPIRIS valve so important for the advancement of valve therapy?<\/h2>\n

\u201cThere are three aspects that are important,\u201d replied Dr. Svensson. \u00a0\u201cFirst, the valve has new anti-calcification technology which reduces calcification.* \u00a0Second, the valve is stored \u2018dry\u2019 unlike other valves. \u00a0Third, the valve is designed to expand during potential future valve-in-valve procedure with a transcatheter aortic valve (TAVR) insertion.\u201d<\/p>\n

Let\u2019s examine each of these important points:<\/p>\n

1. \u00a0Blocks Calcium Build-up.<\/strong>\u00a0 The INSPIRIS valve uses the RESILIA tissue, a new type of bovine (cow) tissue with special technology that blocks calcium build-up on the valve.<\/p>\n

Reducing calcium build-up is important because calcium build-up is the main cause of tissue valve failure. \u00a0The new RESILIA tissue has demonstrated significantly less calcium build-up in animal studies.*<\/p>\n

Here are some radiographic examples of explanted valves from the animal study which showed less calcium build-up.(1)<\/p>\n

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2. \u00a0Dry Storage<\/strong>. \u00a0If you didn\u2019t know\u2026 \u00a0Most tissue valves are stored in aldehyde liquid which attracts calcium. \u00a0Thanks to the unique RESILIA tissue, the INSPIRIS valve can be stored dry thereby preventing further exposure to the aldehydes.<\/p>\n

3. \u00a0VFit Technology.^<\/strong>\u00a0 With the approval of TAVR for valve-in-valve procedures in recent years, I was excited to learn that the INSPIRIS valve comes with VFit technology that provides the first-of-its-kind expandable frame specifically designed for potential future valve-in-valve procedures.<\/p>\n

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What is the number one patient benefit of the INSPIRIS valve?<\/h2>\n

Dr. Svensson shared, \u201cThe number one benefit of the INSPIRIS RESILIA valve is less calcium build-up.* \u00a0Patients with biscuspid aortic valves, active lifestyles, and those who do not want mechanical valves could benefit from this new valve.\u201d<\/p>\n

Tissue vs Mechanical Valve Considerations<\/strong><\/p>\n

A key selection criteria for patients going through the valve selection process is durability. \u00a0The more durable a valve is, the less chance a re-operation will be required.<\/p>\n

Mechanical valves are designed with durable materials that may last longer. \u00a0However, patients with mechanical valves require a lifelong treatment of anticoagulants (blood thinners) to avoid clots on the valve.<\/p>\n

Tissue valves, on the other hand, do not require the use of blood thinners and typically last between 10 to 20 years depending on the type of valve, patient characteristics and other factors. \u00a0That said, the INSPIRIS valve with the more resilient tissue and expandable valve frame may be an attractive benefit for patients who do not want to be on blood thinners for the rest of their life.*<\/p>\n

Here are some additional considerations when comparing tissue and mechanical valves:<\/p>\n

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How are patients with the INSPIRIS valve doing?<\/h2>\n

\u201cAlmost 700 patients were enrolled in the FDA trial, known as the COMMENCE aortic trial, which supported the approval of the INSPIRIS valve,\u201d Dr. Svensson responded. \u00a0\u201cThere have been no structural failures of the study valve during the trial out to 3 years which we reported at the recent American Association for Thoracic Surgery Conference, and hence we did not have any re-operations due to structural valve failures.\u201d \u00a0This is obviously an encouraging result for a breakthrough technology.<\/p>\n

A new resilient valve for patients!<\/strong><\/p>\n

This is a sensational development for patients with aortic valve disease. \u00a0A new resilient tissue valve that reduces calcium build-up and is specifically designed for potential future valve-in-valve procedures is extremely promising.<\/p>\n

Many thanks to Dr. Lars Svensson<\/a> for sharing his clinical experience and research specific to the INSPIRIS valve with our community.<\/p>\n

In addition, I would like to congratulate Edwards Lifesciences for the FDA approval of the INSPIRIS valve. \u00a0We are optimistic that it will help many patients in our community!<\/p>\n