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Aortic valve stenosis (narrowing of the aortic valve) is one of the most common forms of heart disease. Its prevalence increases with the increase in life expectancy.

It is estimated that 25% of the population over the age of 64 suffer from this disease. (1-3)

Historically, the only solution for patients with severe symptomatic aortic stenosis, was valve replacement performed under open heart surgery.

Over the last few years, with the development of minimally invasive approaches for implanting an aortic valve – a procedure called Trans-Catheter Aortic Valve Replacement, or TAVR - the cardiovascular field is undergoing a revolution.

With experience gained and clinical data available, TAVR may become a preferred approach over surgery for many patients. However, TAVR has several limitations:

A biological valve implant has limited durability, which is still unknown. If a biological valve is implanted in a patient who has a long life expectancy, there is a risk that the valve will deteriorate and a new valve will need to be implanted into the first one. These valve-in-valve procedures are suboptimal, so deferring the need for implantation may be advantageous for many patients.
The TAVR procedure requires a relatively large profile catheter, which might lead to vascular complications, and in some patients might not be possible at all.

TAVR might lead to neurological complications.

TAVR might lead to the need for permanent pacemaker implantation.

(4-13)

TAVR is an expensive procedure which may limit its clinical adoption in many countries. It puts a significant burden on healthcare systems which need to make tough choices when considering how to allocate budgets. (14)

Pi-Cardia developed a unique alternative approach to valve replacement – the Leaflex™ - a non-implant-based low profile catheter designed to repair the calcified aortic valve, and potentially delay the progression of the disease and defer or obviate the need for valve replacement.

Pi-Cardia believes that the first line of treatment for aortic stenosis should be a conservative repair of the patient’s own native valve. If repairing the valve can delay the onset of symptoms by a few years, then the patient may not need to have open heart surgery for valve replacement, and TAVR can be used more selectively only when patients absolutely need a new valve implanted.

The target pricing for Leaflex™ will be lower than TAVR, potentially allowing wide adoption in countries where budget is a major consideration.

Pi-Cardia’s goal is to eventually create a broader range of treatment options for patients with valve disease so healthcare systems, physicians and patients have more options.

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(1) Lindroos et al. Prevalence of aortic valve abnormalities in the elderly: an echocardiographic study of a random population sample. J Am Coll Cardiol. 1993; 21: 1220–1225.

(2) Stewart et al. Clinical factors associated with calcific aortic valve disease: Cardiovascular Health Study. J Am Coll Cardiol. 1997; 29: 630–634.

(3) Otto et al. Association of aortic-valve sclerosis with cardiovascular mortality and morbidity in the elderly. N Engl J Med. 1999; 341: 142–147.

(4) Moat et al. Long-Term Outcomes After Transcatheter Aortic Valve Implantation in High-Risk Patients With Severe Aortic StenosisThe UK TAVR (United Kingdom Transcatheter Aortic Valve Implantation) Registry. Journal of the American College of Cardiology 58, no. 20 (2011): 2130-2138.

(5) Généreux et al. Transcatheter aortic valve implantation 10-year anniversary: review of current evidence and clinical

(6) Khawaja et al. Standalone balloon aortic valvuloplasty: indications and outcomes from the UK in the transcatheter valve era. Catheterization and Cardiovascular Interventions 81, no. 2 (2013): 366-373.

(7) Helge et al. In-hospital outcome of transcatheter vs. surgical aortic valve replacement in patients with aortic valve stenosis: complete dataset of patients treated in 2013 in Germany. Clin Res Cardiol. 2016 Jun;105(6):553-9.

(8) Tamburino et al. 1-Year Outcomes After Transfemoral Transcatheter or Surgical Aortic Valve Replacement Results From the Italian OBSERVANT Study. Am Coll Cardiol 2015;66:804–12.

(9) Sedaghat et al. Outcome in TAVR Patients with Symptomatic Aortic Stenosis not Fulfilling PARTNER Study Inclusion Criteria. Catheterization and Cardiovascular Interventions 86:1097–1104 (2015).

(10) Agarwal et al. Transcatheter aortic valve replacement: current perspectives and future implications. Heart Online First, published on November 19, 2014 as 10.1136/heartjnl-2014-306254.

(11) Davies, et al. European Experience and Perspectives on Transcatheter Aortic Valve Replacement. Prog Cardiovasc Dis. 2014 May-Jun;56(6):625-34.

(12) Hamm et al. The future of transcatheter aortic valve Implantation. European Heart Journal (2016) 37, 803–810.

(13) Stefano et al. on behalf of the OBSERVANT Research Group. Transcatheter Aortic Valve Implantation Compared With Surgical Aortic Valve Replacement in Low-Risk Patients. Circ Cardiovasc Interv. 2016;9:e003326.

(14) Manolis. Transcatheter aortic valve implantation economics: a grisly reality, Annals of cardiothoracic surgery, 2017;6(5):516-523.