Abbott Laboratories has taken a giant step forward in the transcatheter heart valve space with CE mark approval of its Tendyne transcatheter mitral valve implantation (TMVI) system. This milestone marks the first TMVI device to gain regulatory approval worldwide, and subsequently physicians will now have a new option with which to treat patients who suffer from certain mitral valve diseases but are not eligible for open surgery.
The Tendyne device is designed to treat mitral valve regurgitation (MR). MR is the most common heart disease affecting heart valves; GlobalData estimates that there were slightly fewer than 2.2 million prevalent cases of MR in 2019 in the US alone. Currently, patients with MR have a number of interventional treatment options: some patients receive open heart surgery to repair or replace the mitral valve, while some patients receive mitral valve repair via a transcatheter procedure (transcatheter mitral valve repair, or TMVR). Abbott is already the clear market leader in the TMVR space with its MitraClip device, which is currently the only commercially available TMVR device in the US, although other devices are available in other regions such as Europe.
With CE mark approval of the Tendyne device, Abbott has significantly increased the potential pool of patients that can be treated with its suite of devices. For those who are ineligible to undergo mitral valve repair with the MitraClip, the Tendyne offers a minimally invasive alternative. According to a press release by Abbott, 98.9% of patients who received the Tendyne were discharged with complete elimination of MR, and this was sustained through one year of follow-up. In 2018, Abbott began a pivotal clinical trial of its Tendyne device in the US (the SUMMIT trial), and upon completion, data from this trial will be used for submission to the FDA for regulatory approval.
Abbott is not the only company with plans to develop a TMVI device. LivaNova had been developing its own TMVI device, the Caisson device, until it cancelled its development programme in late 2019. Medtronic is currently developing the Intrepid system, and received FDA approval to begin an early feasibility study for its device in September 2019. A handful of other companies are developing similar devices. However, the fact that Abbott’s Tendyne system was the first to receive CE mark approval gives Abbott a huge competitive advantage in the market. Other companies will have to demonstrate clear advantages of their devices through rigorous clinical trial testing in order to compete.