roduct Name: CardioPulse X1000 – Implantable Cardioverter Defibrillator (ICD)
Product Category: Cardiac Devices
Manufacturer: MedNova Technologies
Model Number: CPX1000
Release Date: March 2024
Product Overview:
The CardioPulse X1000 is a next-generation implantable cardioverter defibrillator (ICD) designed to monitor and treat life-threatening cardiac arrhythmias. It delivers precise electrical shocks to restore normal heart rhythm in patients with ventricular tachycardia or fibrillation.
Key Features:
- Smart Rhythm Detection: AI-powered arrhythmia classification reduces false positives.
- Dual-Chamber Sensing: Supports both atrial and ventricular monitoring.
- Wireless Telemetry: Real-time data transmission to clinicians via secure cloud.
- Battery Life: Up to 10 years with adaptive energy management.
- MRI Compatibility: Safe for MRI scans under specified conditions.
- Remote Monitoring: Integrated with the MedNova CareLink platform for 24/7 patient tracking.
Technical Specifications:
- Dimensions: 45 mm × 52 mm × 8 mm
- Weight: 28 grams
- Shock Energy: Up to 40 Joules
- Lead Compatibility: IS-1/DF-1 standard
- Operating Temperature: 32°F to 104°F (0°C to 40°C)
Certifications & Compliance:
- FDA Approved (Class III Medical Device)
- CE Marked (EU MDR Compliant)
- ISO 13485 Certified Manufacturing
Pricing & Availability:
- Base Price: $18,500 USD (excluding leads and surgical costs)
- Available Regions: North America, EU, APAC
- Warranty: 5 years standard, extendable to 7 years
Common Use Cases:
- Patients with a history of sudden cardiac arrest
- Individuals diagnosed with ventricular arrhythmias
- High-risk patients with reduced ejection fraction post-MI