Hypertrophic cardiomyopathy is a disease known to occur at a rate of 1 in 500 people, and is a disease that causes abnormal thickening of the myocardium, which causes the heart to deform and fail to function normally.
In about 10% of patients with hypertrophic cardiomyopathy, the left ventricular outflow tract narrows due to pathological hypertrophy of the myocardium, which puts a load on blood flow from the left ventricle to the aorta, causing more symptoms of heart function. This case is specifically called hypertrophic obstructive cardiomyopathy (HOCM).
The standard treatment method for hypertrophic cardiomyopathy is surgical treatment, and in the case of HOCM, the symptoms are severe enough to the extent that the patient's daily life is difficult, so treatment to resolve the symptoms is required. The current standard treatment is to resect the thickened myocardium through thoracotomy (myocardial resection, septal myectomy).
This treatment is accompanied by open thoracic and high complications, so in many cases, patients are not well treated.
[Overview of myocardial resection (top) and
myocardial resection through thoracotomy (bottom)]
Recently, in China, a method of RF ablation in which the myocardium is resected using a radiofrequency electrode through a needle penetrating the heart into a thickened myocardium was introduced for the first time in the world. The results of the study are incredibly good, and the article was published in JACC, the most authoritative journal in the field of cardiology in 2018.
Although this method is a minimally invasive method, it is attracting the attention of academia for its excellent therapeutic effect that was not expected in septal alcohol ablation. Still, the dangerous approach of having to penetrate the heart from the chest wall through a thick needle remains a problem to be solved.
As an alternative to such surgical treatment, we are developing a catheter-based ventricular septal RF ablation catheter technology, which can be applied to HOCM patients as a safer and more convenient procedure.
There are 36,000 new cases of HOCM annually,
and catheter-based treatment is estimated to have a market of $400 million (KRW 500 billion) annually, targeting 20% of these patients.
In addition, with the expansion of the intravascular RF ablation catheter, it is estimated to have a market size of $500 million (KRW 600 billion) per year for preemptive ablation before TMVR treatment (mitral valve replacement), and $60 million (KRW 70 billion) per year for intramyocardial ablation for ventricular tachycardia treatment.
Pacemaker therapy, used for electrotherapy of bradycardia or heart failure, is a big market with a market size of over $15 billion.
Current pacemaker treatment uses a method of placing a lead on the apical right ventricle and applying electrical stimulation, which has a serious disadvantage of (1) heart failure due to a delay in ventricular electrical conduction (wide QRS) (2) tricuspid regurgitation (20-30%).
[Limits of Conventional Pacemaker Therapy]
To overcome these shortcomings, there are His bundle pacing (HBP) that provides electrical stimulation by placing a lead in His bundle, the electrical conduction system of the ventricle, or CRT that performs biventricular pacing by applying stimulation from two ventricles. However, both methods are not easy to apply because the procedure is not convenient and expensive (2~30 million won), and in the case of HBP there is a risk that the lead may be dropped out.
A technology developed by our company, has the advantage that it can directly act on the electrical conduction system of the heart as it can access a specific area of the heart (ventricular septum) with a simple minimally invasive procedure.
His pacing and pacing have a core common function in terms of directly transmitting electrical stimulation to the His bundle, the core axis of the heart conduction path, or the surrounding area.
|His Pacing||Thru-Septal Pacing|
|Final electrical stimulation target site||His bundle and adjacent tissues||His bundle and adjacent tissues|
|Approach path||Right atrium and right ventricle||Coronary sinus and ventricular septal veins|
|Applicable pacemaker leads||Only available with Medtronic's Select Secure 3830 lead||All leads of over the wire type can be used (Medtronic, Boston, St Jude, etc.)|
|Holds Relatively Rich Clinical Data||Holds Relatively Rich Clinical Data||Obtaining Initial Clinical Data|
|Relative comparative disadvantages||1. In 10-20% of patients, it is difficult to locate the lead by finding the appropriate point.
2. The high Pacing output causes shortening of the life of the pacemaker battery.
1. General surgeons need education on the procedure as a new approach to treatment
2. In addition to the pacemaker's general device tools, accessory devices necessary for the procedure are required (this is the company's development item) (this is the company's development item)
3. The procedure is affected by the septal vein structure.
|Clinical usefulness||Positioning as a new alternative to pacemaker and ventricular synchronization therapy||Provides wider treatment opportunities as an alternative to other approaches for His pacing|