The Evolving and Expanding Structural Heart Therapeutic Interventions

Structural heart diseases (SHDs) are the structural abnormalities in the heart’s chambers and valves that usually range from the congenital abnormal communications between the chambers of the heart to the acquired valvular diseases. The incorrectly shaped or damaged cardiac structures that alter blood flow and lead to various serious complications like stroke, cardiac arrest or heart failure warrant efficient structural heart interventions. Structural heart devices consist of the various therapeutic interventional devices used to efficiently and economically close the abnormal communications between the heart chambers or to reconstruct or replace a diseased or degenerated heart valve through the adoption of a multidisciplinary remedial approach.

Structural heart devices global market is expected to reach $17,433.4 million by 2027 growing at a double digit CAGR from 2020 to 2027. Increasing adoption and preference of minimally invasive therapeutic surgical procedures for various kinds of structural heart diseases, persistently elevating geriatric population who are ineligible for open heart surgical interventions, availability of various technologically advanced and minimally invasive structural heart therapeutic products and advanced imaging techniques to finely elucidate, treat and diagnose the structural abnormalities of the heart are currently driving the market growth. Factors like increasing expanded indication approval of various transcatheter structural heart products for intermediate risk or low risk patients, increasing R&D spending for developing novel, innovative and technologically advanced products are further substantiating enormous growth opportunities of the market. Elevating inclination of the value-centric global patient pool towards the technologically advanced structural heart products with better therapeutic outcomes, the need to reduce hospitalization duration and ease the patient’s condition through faster and more durable structural heart interventions are boosting the various advancements in the structural heart devices global market. To gain more market share by bringing innovative and differentiated products to the market and to stay abreast in the patient-driven market with smart and superior medical devices, the structural heart device manufacturing companies are constantly striving for the launch or approval of their innovative structural heart devices and up-gradation of or expanded indication approval for their approved, proprietary products.

Incredible technological advancements in the rapidly evolving and growing structural heart disease field have resulted in an exponential transition from the invasive open-heart surgical procedures to image-guided, less invasive transcatheter or percutaneous structural heart procedures for these life threatening structural heart diseases. The substantial benefits associated with these non-traumatic and aesthetically appealing minimally invasive surgical procedures like better therapeutic outcomes, reduced hospitalization period, faster recovery, less bleeding risks and reduced risk of other complications, minimal post-operative pain and morbidity are causing the current increasingly aware and tech-savvy patients to prefer the transcatheter therapeutic approaches for SHDs. These transcatheter therapeutic procedures with highly efficient, technologically advanced products assure patients and healthcare providers with improved efficiency, effectiveness and quicker restoration of the non coronary physical defects of the heart. They have become the norm or standard of care for inoperable patients or patients at high risk for open-heart surgical procedures.

The first revolutionary, overwhelmingly successful and exponential shift from open-heart procedures to transcatheter procedure was exhibited in the aortic valve replacements but currently, transcatheter approaches for mitral valve repairs,  ventricular remodeling, pulmonary and tricuspid valve replacement, patent foramen ovale (PFO) closure are also gradually gaining ground and momentum. According to IQ4I estimates, in 2020, approximately 152,014 transcatheter aortic valve replacement (TAVR) procedures will be performed globally. The penetration of TAVR procedures is estimated to reach 9.8% by 2027 among the global aortic stenosis patient pool. In July 2019, Abbott Laboratories received FDA approval for its most advanced MitraClip heart valve repair device, MitraClip G4, to treat mitral regurgitation. In March 2019, the company had also received FDA approval for a new, expanded indication to its leading MitraClip device used to repair a leaky mitral valve without open-heart surgery. Several transcatheter devices like micro-anchor systems to restore shape and function of left ventricle and thus reduce the long term morbidity and mortality associated with the disease, have been developed and are also being developed. In January 2020, Revivent TC Transcatheter Ventricular Enhancement System of BioVentrix Inc., developer of the first left ventricular remodelling transcatheter device, received extension of European CE mark approval till May 2024. Companies are also venturing and racing into the less explored but of potential growth valve disease areas like the tricuspid valve diseases to offer differentiated and innovative transcatheter products and gain a competitive advantage over their peers. With the CE Mark approval for Abbott's TriClip Transcatheter Tricuspid Valve Repair System in April 2020, it became the first minimally invasive, clip-based tricuspid valve repair system to be commercially available in the world.

Another emerging trend currently observed in the structural heart disease field is expanded indication approval for the various transcatheter products whose usage was previously restricted for only inoperable, high risk patients. The expanded indication approval for these various transcatheter products increases the accessibility of these efficient products and widens the number of eligible patients for these technologically advanced procedures. In August 2016, Edwards Sapien 3 and Sapien XT gained FDA approval that extended the use of these TAVR products in intermediate risk patients. In November 2019 Edwards Lifescience’s Edwards SAPIEN 3 transcatheter heart valve received CE mark approval to expand use of the device for the treatment of aortic stenosis patients who are at low risk for open-heart surgery. In August 2019, the FDA further approved an expanded indication for several transcatheter heart valves like Sapien 3, Sapien 3 Ultra of Edwards and Medtronic’s CoreValve Evolut R and CoreValve Evolut PRO so as to include patients with severe aortic valve stenosis at low surgical risk. These expanded indication approvals for the previously approved products is based on the evaluated evidences from clinical trials in the premarket settings and real-world clinical data in the post-market settings that ensure patients without any risk stratification can have access to these safe, high-quality and efficient medical devices. In March 2020, Medtronic announced that it’s Evolut TAVR System has demonstrated excellent outcomes in study of Low-Risk Patients with Bicuspid Aortic Stenosis. Boston Scientific has also begun enrolling intermediate-risk patients for REPRISE IV clinical trial to evaluate the efficacy of their previously approved Lotus Edge TAVR device in these patients.

To meet the persistently elevating demands of easy to use and patient centric structural heart devices with minimal traumatizing effects, reduced infection risk rates, accelerated recovery rates and better therapeutic outcomes, companies and research organizations across the globe are now currently focusing on developing non invasive, highly efficient structural heart products. So a gradual transition or evolution from the minimally invasive therapeutic procedures to non invasive therapeutic procedures is also expected in the near future. The French Company, Cardiawave has developed a non-invasive medical device, Valvosoft, based on ultrasound technology, to treat aortic stenosis. This non-invasive, painless therapeutic device offers several advantages like high precision, repeatability, ability to treat several anatomical zones simultaneously, immediate therapeutic effects with a decreased rate of morbidity and other complications. Thus the field of structural heart interventions is constantly evolving from the conventional invasive to the current more patient friendly, minimally invasive and to the futuristic non invasive therapeutic structural heart interventions and is also expanding its accessibility to global patient pool without any risk stratification parameters.

The structural heart devices market is consolidated with the top five players occupying major part of the market and the remaining companies occupying only a minority share of the market. The top players in structural heart devices market are Edwards Lifesciences Corporation (U.S.), Medtronic PLC (Ireland), Abbott Laboratories (U.S.), Livanova PLC (U.K.), Boston Scientific Corporation (U.S.), Cryolife Inc. (U.S.), AtriCure, Inc. (U.S.), Venus Medtech (Hangzhou) Inc (China), Lifetech Scientific Corporation (China), NuMed Inc. (U.S.) and others.



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