Regulatory Decision Summary for Nanostim Leadless Cardiac Pacemaker
Review decision
The Regulatory Decision Summary explains Health Canada’s decision for the product seeking market authorization. The Regulatory Decision Summary includes the purpose of the submission and the reason for the decision.
Product type:
Summary of Withdrawal - Nanostim Leadless Cardiac Pacemaker
Medicinal ingredient(s):
Therapeutic area:
Type of submission:
Control number:
Overview
What was the outcome of the application?
Withdrawn by the manufacturer following review and request for additional information, but prior to issuance of a decision by Health Canada.
Date of Action
2016-11-22
What was the application for at the time of decision?
The leadless cardiac pacemaker system: Implantation of a single-chamber pulse generator is indicated in one or more of the following permanent conditions:
- Syncope;
- Presyncope;
- Fatigue;
- Disorientation;
- Or any combination of those symptoms.
Rate-Modulated Pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity. Chronotropic incompetence has not been rigorously defined. A conservative approach, supported by the literature, defines chronotropic incompetence as the failure to achieve an intrinsic heart rate of 70% of the age-predicted maximum heart rate or 120 bpm during exercise testing, whichever is less, where the age-predicted heart rate is calculated as 197 - (0.56 x age).
Ventricular Pacing is indicated for patients with significant bradycardia and:
- Normal sinus rhythm with only rare episodes of A-V block or sinus arrest;
- Chronic atrial fibrillation;
- Severe physical disability.
The Nanostim Leadless Cardiac Pacemaker (LCP) provides bradycardia pacing as a pulse generator with built-in battery and electrodes, for implantation in the right ventricle. The Nanostim Leadless Pacemaker System includes a deflectable delivery catheter, designed to allow introduction of the Nanostim LCP via a percutaneous access site in the femoral vein.
As a leadless device, it does not need a connector, pacing lead, or pulse generator pocket. A distal non-retractable, single-turn helix affixes the device to the endocardium. Sensing and pacing occur between a distal electrode near the helix and the external can of the device. The devices proximal end has a feature for docking to delivery and retrieval catheters providing for repositioning and retrieval capability. The device communicates bi-directionally with the Nanostim Programmer Link via electrical signals conducted between the implanted devices electrodes and skin electrodes applied to the patients chest and connected to the programmer.