Stelix II Endocardial Pacing Leads

No FDA recalls found in the data synced 22 Oct 2026.

Trade Name

Stelid II/Stelix/Stelix II Endocardial Pacing Lead

Generic Name

Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes

FDA applicant

MicroPort CRM S.r.l.

PMA Number

P020030 ↗

FDA Product Code

NVN

Device Class

Class III

Advisory Committee

Cardiovascular

FDA Decision

APPR Approved

• VEGA Steroid-Eluting Endocardial Leads (VEGA™ R45, VEGA™ R52, and VEGA™ R58)

  Class III

  FDA PMA P130010 Active Approved 17 May 2023

• Angeion Sentinel Implantable Cardioverter Defibrillator (Icd)System and the Angeflex Tm Defibrillation Lead System.

  Class III

  FDA PMA P970024 Withdrawn Approved 19 Aug 1998

• Paradym CRT-D; Paradym RF CRT-D (ZL101), (ZL102); Intensia CRT-D; Platinium CRT-D 1711, 1741.

  Class III

  FDA PMA P060027 Active Approved 15 May 2008

• Ovatio Vr/Dr

  Class III

  FDA PMA P980049 Active Approved 15 Sep 1999

• Chorus DDD Pacemaker

  Class III

  FDA PMA P900022 Active Approved 6 Sep 1991

• SMARTVIEW hotspot

  Class III

  FDA PMA P950029 Active Approved 10 Mar 1997

• What are the key differences between the atrial and ventricular models of the Stelix II Endocardial Pacing Leads?

  The Stelix II atrial models (e.g., BRF25D/26D) feature retractable-screw designs for secure fixation in the right atrium, while the ventricular models (e.g., BTF25D/26D) use fixed-coil configurations for pacing and sensing in the right ventricle. Both are drug-eluting to reduce impedance and improve long-term performance, but their mechanical anchoring differs to suit their respective chambers.

• Are the Stelix II Endocardial Pacing Leads intended for temporary or permanent use?

  These leads are explicitly designed for **permanent** use with implantable pacemakers, as stated in the FDA Premarket Approval (PMA P020030). They are not intended for short-term or temporary pacing applications.

• How should the sterile packaging of the Stelix II leads be handled during storage?

  The leads are supplied sterile, so storage must adhere to sterile packaging protocols to maintain integrity. This includes keeping them in unopened, sealed packaging until immediate use and avoiding exposure to contaminants or environmental conditions that could compromise sterility.

• What regulatory pathway was followed for the approval of the Stelix II Endocardial Pacing Leads?

  The Stelix II leads were approved via the **FDA Premarket Approval (PMA)** process, with PMA number **P020030**. This pathway is required for Class III devices, which include permanent pacemaker electrodes due to their high-risk nature. The approval was granted in 2004 after review by the FDA’s Cardiovascular (CV) advisory committee.

• Can the Stelix II leads be reused after a single procedure?

  No, the Stelix II Endocardial Pacing Leads are **single-use devices** intended for permanent implantation. Reuse is not supported by the manufacturer or the FDA’s approval criteria, as this could compromise patient safety and device performance.