Breakthrough Clinical Results
EnChannel Medical announced the acquisition of Acutus Medical's AcQMap™ High Resolution Imaging and Mapping platform assets. This acquisition strengthens EnChannel's intellectual property portfolio by integrating key innovations in non-contact mapping (NCM) technologies for atrial fibrillation (AF) treatment. AcQMap™, a second-generation NCM platform, improves spatial resolution and accuracy compared to first-generation systems. EnChannel's proprietary Action Potential Mapping, a third-generation NCM technology, further enhances mapping by reconstructing both depolarization and repolarization dynamics. This acquisition allows EnChannel to advance its holistic platform for AF treatment, combining navigation, echocardiography, mapping, and ablation techniques.
Key Highlights
- Acquisition of Acutus Medical's AcQMap™ electrophysiology assets.
- Integration of second-generation non-contact mapping (NCM) technology.
- Advancement of EnChannel's proprietary third-generation Action Potential Mapping.
- Strengthened intellectual property portfolio for atrial fibrillation (AF) treatment.
Incidence and Prevalence
Global Atrial Fibrillation Epidemiology: Latest Estimates
Global Prevalence
According to the Global Burden of Disease Study 2017, there were 37.57 million prevalent cases of Atrial Fibrillation (AF) globally in 2017 (with a 95% uncertainty interval [UI] of 32.55-42.59 million). The worldwide prevalence of atrial fibrillation is 0.51% of worldwide population, which increased by 33% during the last 20 years.
It is currently estimated that AF affects approximately 2% of the general population; however, the true prevalence is likely to be at least 3%-4% when asymptomatic AF is considered.
Regional prevalence data shows significant variation: - In a European population-based study (Rotterdam study), the overall prevalence was 5.5%, rising from 0.7% in the age group 55-59 years to 17.8% in those aged 85 years and above. - In a study of elderly Chinese (≥60 years), the baseline prevalence was 2.0% in men and 1.6% in women. - In south of England, the age standardized prevalence of diagnosed atrial fibrillation was 1.23% (1.28% for men and 1.18% for women), with much higher rates in the older population: 8.28% for males and 6.66% for females over 65.
Global Incidence
The Global Burden of Disease Study 2017 reported 3.05 million incident cases (95% UI 2.61-3.51) of AF globally in 2017. According to the Global Health Data Exchange database, a total of 3.046 million new cases of atrial fibrillation worldwide were registered during 2017.
The estimated global incidence rate for 2017 was 403 per million inhabitants, which was 31% higher than the corresponding incidence in 1997.
Regional incidence data shows: - In the European study, the overall incidence rate was 9.9/1000 person-years. The incidence rate in the age group 55-59 years was 1.1/1000 person-years, rising to 20.7/1000 person-years in the age group 80-84 years. - In elderly Chinese, the incidence rate was 4.9 per 1000 person-years (95% CI, 3.4-6.9). - In France, the incidence of AF is estimated at between 110,000 and 230,000 new cases per year.
Regional Variations and Risk Factors
The age-standardized rates of prevalent cases, incident cases, and deaths of AF in 2017 and their temporal trends from 1990 to 2017 varied significantly by socio-demographic index (SDI) quintile and location. The highest burden of AF is seen in countries with high socio-demographic index, though the largest recent increase occurred in middle socio-demographic index countries.
Regional variations in outcomes exist: twice as many patients had died by 1 year in South America (17%) and Africa (20%) compared with North America, western Europe, and Australia (10%). The highest number of strokes occurred in patients in Africa (8%), China (7%), and southeast Asia (7%) and the lowest in India (<1%).
The leading risk factors for AF age-standardized deaths in 2017 were: - High systolic blood pressure (34.3% [95% UI 27.4-41.5]) - High body mass index (20.7% [95% UI 11.5-32.2]) - Alcohol use (9.4% [95% UI 7.0-12.2])
Future Projections
Future projections suggest that absolute atrial fibrillation burden may increase by more than 60% in 2050. It has been estimated that 6-12 million people will suffer from AF in the US by 2050 and 17.9 million people in Europe by 2060.
Mechanism of Action
Three Most Common Mechanisms of Action in Trials for Unapproved Atrial Fibrillation Drugs
Based on clinical trials, the three most common mechanisms of action for drugs that have not been approved specifically for atrial fibrillation include:
1. Direct Factor X Inhibition
Several compounds in this category are orally available direct inhibitors of activated factor X that were under development for thromboprophylaxis in patients with atrial fibrillation. These include:
- Rivaroxaban
- Apixaban
- Betrixaban
- Eribaxaban
While rivaroxaban had already received approval in the European Union and Canada at the time of the study, trials comparing the efficacy of rivaroxaban or apixaban to standard therapy for stroke prophylaxis in patients with atrial fibrillation were still ongoing.
2. Beta-adrenergic Blockade
Beta-blockers have been extensively studied for various cardiovascular conditions, though not specifically approved for atrial fibrillation. Notable examples include:
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Bisoprolol: In the TIBBS study, bisoprolol was found to be significantly more effective than nifedipine in reducing transient ischemic episodes.
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Metoprolol: This beta-blocker was studied for rate control in atrial fibrillation with rapid ventricular rate. Studies showed no statistically significant difference compared to diltiazem and verapamil in achieving rate control.
3. Calcium Channel Blockade
Calcium channel blockers represent another important class of drugs studied for cardiovascular conditions including atrial fibrillation:
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Verapamil: This agent was investigated for rate control in atrial fibrillation with rapid ventricular rate, with median time to ventricular rate control of 100.5 minutes.
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Nifedipine: This calcium channel blocker has been studied for its effects on transient ischemic episodes and compared with beta-blockers, though it was less effective than bisoprolol in the TIBBS study.
It's important to note that some drugs with these mechanisms have subsequently received approval for atrial fibrillation-related indications. However, at the time of the studies referenced, many were still undergoing clinical evaluation or were approved for other indications but used off-label for atrial fibrillation management.
Company Mechanism of Action
Mechanisms of Action of EnChannel Medical Ltd. Drugs
After a thorough review of the available information, I cannot provide details about the mechanisms of action for drugs from EnChannel Medical Ltd. The information about this company and its pharmaceutical products is not present in the provided context. There is no data available regarding the specific pharmacological mechanisms, molecular targets, or signaling pathways affected by any therapeutic agents from this company.