By Matthew Choi and Kamran Zamanian, Ph.D., iData Research Inc.

Heart valve replacement procedures are a type of cardiac surgery. Generally, heart valve replacement is an open operation. However, recent advancements in technology has allowed for minimally invasive heart valve replacement procedures. Heart valve repair is required if the patient is suffering from valve regurgitation, insufficiency or incompetence. These conditions cause the blood flow to be impaired and leak between chambers or flow backwards. In surgical heart valve replacement, there were traditionally two types of heart valves used: stented and stentless. Recently, a new type of heart valve was approved by the FDA, sutureless heart valves.

Heart Valve Repair and Replacement

Damaged heart valves can be repaired or replaced through several different products. For open heart surgery, a surgeon can use tissue heart valves, mechanical heart valves or annuloplasty products. Minimally invasive procedures include transcatheter heart valve replacement and transcatheter heart valve repair. Traditionally, surgical tissue heart valves made up the majority of the market, but this market has since slowed down in growth due to market maturity and the high number of competitors.

Mechanical heart valves are a direct substitute for tissue heart valves. Mechanical heart valves have some benefits but there are also many disadvantages. The major benefit mechanical heart valves have compared to tissue heart valves would be the durability mechanical heart valves provides. The drawbacks of mechanical valves involve patients requiring anti-coagulants for the rest of their lives and the fact that the heart valves do not grow with the patient’s heart, meaning child patients will need to replace the valve (Verheugt, F. W. 2015).

For heart valve repair, there is annuloplasty and transcatheter heart valve repair. Heart valve repair has been growing as surgeons are moving towards repair over replacement. Annuloplasty is the open-heart surgery option, while transcatheter heart valve repair is the minimally invasive option. Both procedures have been growing, with transcatheter heart valve repair growing at a much higher rate compared to annuloplasty.

The largest competitor for tissue heart valve replacement would be the transcatheter heart valve replacement procedure. Transcatheter heart valve replacement is the minimally invasive option for heart valve replacement, which has grown exponentially since its introduction to the market. Transcatheter heart valve replacement is able to reach a number of previously inoperable patients as well as reducing the pain and duration of hospitalization of patients.

Tissue heart valves are segmented into three segments: stented, stentless and sutureless heart valves. Stented tissue heart valves have traditionally dominated the market, with stentless accounting for a minor portion of the market. Sutureless tissue heart valves recently entered the market, gaining FDA approval in 2016. With sutureless heart valves, the tissue heart valve market could get back some of the growth that has been lost.

Sutureless Heart Valves

Sutureless heart valves are currently produced by two companies, LivaNova and Edwards Lifesciences. LivaNova offers their Perceval™ sutureless heart valve, while Edwards Lifesciences has their Intuity™ rapid deployment valve. Edwards Lifesciences’ rapid deployment valve uses three sutures but will still be considered a sutureless valve for the purposes of this article. Currently, sutureless heart valves do not have a presence in the market due to being a new entry, but they should outgrow stented and stentless valves over the next several years.

The main drive for sutureless heart valves is the decreased operating time that sutureless valves provides compared to stented and stentless heart valves (Chandola et al, 2015). Sutureless heart valves have been noted to reduce operating times of surgeons by 30%. By decreasing the operating time, a surgeon is able to go through more patients. Conversely, minimally invasive procedures take an extensive amount of time and steep learning curve due to the difficulty the procedure provides (Feldman, T. 2011.).

Sutureless heart valves are not without its faults. Sutureless heart valves have a higher average selling price (ASP) compared to regular stented and stentless tissue heart valves. However, it is still a much lower costing product compared to transcatheter heart valve replacement products. Another issue sutureless heart valves would be the population it can reach. The regular tissue heart valve market is fairly mature and sutureless heart valves do not add any new types of patients. Transcathter heart valve replacement products are successful because they were able to reach a population of inoperable patients due to their risk status deterring them from open heart surgery (Hayashida, K. & Lefevre, T. 2011). So, while sutureless heart valves may be a better product, the market may not expand and grow and therefore only cannibalizes the existing stented and stentless tissue heart valve markets.

Major Competitors

The LivaNova Perceval™ sutureless heart valve and the Edwards Lifesciences Intuity™ rapid deployment valve, face competition from different companies. Medtronic is another large competitor with their wide range of tissue heart valves, annuloplasty options and CoreValve Evolut R® Transcatheter Aortic Valve Replacement product.

Overall, the heart valve repair and replacement market is experiencing many technological innovations. Sutureless heart valves could be the product to give the tissue heart valve segment renewed growth. However, with strong competitors in transcatheter heart valves products, sutureless heart valves need to offer a bit more before it can take over the market.

About the Authors

Matthew Choi is a research analyst at iData Research and was the lead researcher for the 2018 Cardiac Surgery Market Report Suite 2018 – MedSuite.

Kamran Zamanian, Ph.D., is president, CEO, and a founding partner of iData Research. He has spent over 20 years working in the market research industry.

About iData Research

iData Research is an international market research and consulting group focused on providing market intelligence for medical device and pharmaceutical companies. iData covers research in: diabetes drugs, diabetes devices, pharmaceuticals, anesthesiology, wound management, orthopedics, cardiovascular, ophthalmics, endoscopy, gynecology, urology, and more.

References

Chandola, R., Teoh, K., Elhenawy, A., & Christakis, G. (2015). Perceval Sutureless Valve – are Sutureless Valves Here? Current Cardiology Reviews, 11(3), 220-228. doi:10.2174/1573403×11666141113155744

Feldman, T. (2011). Learning curve for transcatheter aortic valve replacement. Catheterization and Cardiovascular Interventions, 78(7), 985-986. doi:10.1002/ccd.23429

Hayashida, K., & Lefevre, T. (2011). Transcatheter Aortic Valve Implantation: New Hope for Inoperable and High-Risk Patients. Aortic Stenosis – Etiology, Pathophysiology and Treatment. doi:10.5772/23505

Verheugt, F. W. (2015). Anticoagulation in patients with mechanical heart valves: follow the guidelines! Netherlands Heart Journal, 23(2), 109-110. doi:10.1007/s12471-014-0642-9

US Market Report Suite for Cardiac Surgery and Heart Valve Devices 2018 – MedSuite, iData Research Inc.