New CECP opin­ion pub­lished: Expert pan­el backs extend­ed indi­ca­tion for car­diac pac­ing lead

The Euro­pean Commission’s expert pan­els on med­ical devices have pub­lished a new opin­ion under the Clin­i­cal Eval­u­a­tion Con­sul­ta­tion Pro­ce­dure (CECP), cov­er­ing the INGEVITY+ endo­car­dial lead — a class III active implantable device used for car­diac pac­ing and sensing.

The opin­ion was trig­gered by a pro­posed exten­sion of indi­ca­tion to include left bun­dle branch pac­ing — a nov­el anatom­i­cal tar­get beyond the device’s exist­ing CE-marked use for con­ven­tion­al right atri­al and ven­tric­u­lar pacing.

The expert pan­el from the Cir­cu­la­to­ry Sys­tem sub-group con­clud­ed that the ben­e­fit-risk deter­mi­na­tion is ade­quate, not­ing a safe­ty and per­for­mance pro­file com­pa­ra­ble to oth­er sim­i­lar devices, with no new safe­ty sig­nals iden­ti­fied. How­ev­er, giv­en the absence of long-term data and the evolv­ing nature of device-spe­cif­ic tech­niques, the pan­el rec­om­mend­ed a strength­ened Post-Mar­ket Clin­i­cal Fol­low-up (PMCF) plan.

Source: Euro­pean Commission

Accom­pa­ny­ing this sub­ject we rec­om­mend the fol­low­ing con­tent on our website

• Imple­ment­ing Deci­sion (EU) 2025/1324 on Expert Pan­els for Orphan Devices
• New expert pan­el review in the con­text of the PECP
• MDCG 2025-9 — Guid­ance on break­through devices (BtX)
• Imple­ment­ing reg­u­la­tions on eIFU, well-estab­lished tech­nolo­gies and orphan/pediatric devices in sight