ENOVO - Veritas Bioventions

AT A GLANCE

Primary Safety Endpoint

MACE at 30 Days (Composite)

Primary Efficacy Endpoints

MACE up to 12 Months
Device-related SAEs up to 3 Years
Stent Thrombosis (Acute, Subacute, Late up to 3 Years)

Follow-up Schedule

In-hospital, 30 Days, 6 Months, 12 Months, Up to 3 Years

Data Sources

PMS Data, Follow-up, Clinical Literature, Vigilance & Complaints

1 BACKGROUND

ENOVO – Everolimus Eluting Coronary Stent System is designed for patients with coronary artery disease requiring PCI.

Cobalt Chromium L605 stent platform
Biocompatible and biodegradable polymer coating
Everolimus as the antiproliferative drug

The purpose of this Clinical Evaluation Plan (CEP) is to define the methodology for systematic evaluation of clinical safety and performance throughout its lifecycle.

2 CLINICAL EVALUATION OBJECTIVES

2.1 Primary Objective

To evaluate and continuously confirm the safety and clinical performance of ENOVO in real-world use.

2.2 Clinical Performance Objectives

Device Success Rate (%)
Procedural Success Rate (%)
Target Lesion Revascularization (TLR) rate at 12 months (%)
MACE rate up to 12 months (%)
Angiographic Stent Thrombosis rate (Acute, Subacute, Late)

Compared with published clinical benchmarks of Everolimus-eluting coronary stents.

3 CLINICAL ENDPOINTS

3.1 Primary Safety Endpoint

MACE at 30 days, defined as composite of:

Death
Myocardial infarction
Emergent CABG
Clinically driven TLR/TVR

3.2 Primary Efficacy Endpoints

MACE (%) up to 12 months
Device-related SAEs up to 3 years
Angiographic Stent Thrombosis (%):
- Acute (In-hospital)
- Subacute (≤ 30 days)
- Late (>30 days to 3 years)

4 CLINICAL EVALUATION METHODOLOGY

Clinical evaluation will be based on:

PMS data collected through structured PMS forms after each ENOVO deployment.
One-month MACE follow-up with treating cardiologist.
Long-term clinical follow-up data collected every six months.
Published clinical literature of Everolimus-eluting stents.
Vigilance and complaint trend data.

All collected data will be documented, reviewed, and incorporated into the Clinical Evaluation Report at defined intervals.

5 ANALYTICAL PLAN

The primary analysis will be conducted according to the intention-to-treat principle.

Descriptive statistics:

Count and percentage for categorical variables.
Mean, standard deviation, minimum and maximum for continuous variables.

MACE per patient will be ranked according to severity hierarchy:

1 Death

2 Myocardial Infarction

3 CABG

4 TLR

6 CLINICAL PERFORMANCE AND SAFETY ANALYSIS

Collected clinical data will be analyzed to determine:

Incidence of MACE at defined timepoints.
Incidence of stent thrombosis categories.
Incidence of device-related SAEs.
Trends over time

Observed results will be interpreted in the context of published outcomes for Everolimus-eluting coronary stents to ensure that ENOVO maintains an acceptable safety and performance profile.

7 IDENTIFICATION OF CLINICAL DATA GAPS

Based on currently available PMS and clinical data, the following potential data gaps have been identified:

Limited long-term data beyond 3 years.
Limited subgroup analysis in high-risk populations.
Limited large-scale multicenter registry data.

These gaps do not compromise the current benefit-risk assessment but require continued monitoring.

8 PMCF ACTIVITIES TO ADDRESS DATA GAPS

The following PMCF activities will address identified gaps:

Continued follow-up of implanted patients up to 3 years.
Collection of additional PMS data from multiple geographic sites.
Periodic literature surveillance.
Ongoing safety trend analysis.

9 CONCLUSION

This Clinical Evaluation Plan provides a robust framework to ensure that ENOVO continues to meet applicable safety and performance requirements throughout its intended use and lifecycle.

ENOVO is committed to continuous evaluation, patient safety, and clinical excellence.

FOLLOW-UP SCHEDULE

In-hospital

30 Days

6 Months

12 Months

Up to 3 Years

CLINICAL EVALUATION PLAN (CEP)

ENOVO – Everolimus Eluting Coronary Stent System