Home/ Clinical/ Overview
Clinical Evidence

The data that changes the conversation.

The Patient-Matched Skull Reconstruction System is the first PSI implant in CMF validated by a large-cohort prospective clinical study. 5,000+ cases delivered to date, complication rate consistently < 2%.

At a Glance

The strongest clinical evidence base in patient-matched CMF implants.

< 2%Total complication rate
< 1.7%Infection rate
0%Re-operation for critical failure
5,000+Cases in dataset
What the Evidence Shows

Complication rate comparison vs. literature controls.

Total complication rate

Excellent MedTech 3D PSI< 2%
Titanium mesh (literature)12.2 – 17.4%
PEEK plate (literature)17.2 – 18.5%

Infection rate

Excellent MedTech 3D PSI< 1.7%
Titanium mesh (literature)6.05 – 8.2%
PEEK plate (literature)5.1 – 8.8%

View full complication data

Study Design

Large-cohort prospective. The evidence that procurement and HTA bodies look for.

Design

Large-cohort prospective

Multi-centre, prospective, with active follow-up. Not retrospective. Not single-centre.

Scope

Peri-operative + mid-to-long-term follow-up

Safety and effectiveness endpoints tracked from index procedure through medium-term follow-up.

Sites

50+ clinical partner sites

Including FMMU, Southern Medical University, Shenzhen Second People's Hospital, Beijing Tiantan, Huashan, Xuanwu.

Endpoints

Standardised safety & effectiveness

Infection, re-operation, implant exposure, headache, loosening, subcutaneous effusion, total complications.

Controls

Peer-reviewed literature

Compared against published complication rates for titanium mesh and PEEK plates.

Database

5,000+ cases and growing

Continuously updated post-market database. Real-world evidence continuously feeding design and process improvements.

From Evidence to Practice

Three clinical scenarios where the difference shows.

TBI / DC

Severe TBI + decompressive craniectomy

Young 20–50 yr, 70% male. Large, irregular, often bifrontal defects. Infection risk is the dominant complication with conventional mesh — our < 1.7% infection rate vs. 6–8% with mesh translates to fewer re-operations and shorter inpatient stays.

Aneurysm

Aneurysm rupture reconstruction

40–70 yr. Large, irregular defects. The MEI workflow collapses the traditional "try-fit, re-trim" loop into a single placement — saving 60–90 minutes of OR time per case.

Aesthetic

Aesthetic CMF

30–60 yr. Forehead and temporal contour. The biomimetic dual-surface design and 1:1 curvature restoration deliver the natural aesthetic outcome that drives patient satisfaction.

Independent Recognition

Reviewed by the institutions that set the standard.

Award

Guangdong Science & Technology Invention Award

Second Prize (2020) for core technical innovation in patient-matched AM.

Standards

10 national guidelines

Co-author of 10 national-level guidelines shaping 3D-printed medical device practice.

Peer review

100+ publications

100+ peer-reviewed publications in materials science, biomechanics, and clinical outcomes.

Want the full clinical dossier?

We provide a Clinical Evidence Summary, full complication comparison, and references to procurement, HTA, and ethics committees under NDA.

Request the dossier Clinical studies