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BLT 3D printed WedoCage medical implant receives market approval in China

Source:        DateTime:2023.12.08        Hits:


Metal additive manufacturing company Bright Laser Technologies (BLT) has shared details of its role in the production of a Bioactive Coated Porous Titanium Interbody Fusion Device for Wedo Bio-Medical Technology Co, Ltd.

The Chinese 3D printer manufacturer’s BLT-S210 and BLT-S320 systems have been used by Wedo to produce a number of personalised custom implants and orthopaedic medical devices. This latest device, the WedoCage, has now received market approval after obtaining a Class III Medical Device Registration Certificate from the National Medical Products Administration (NMPA). It follows the First Class III Medical Device Registration Certificate which the medical device manufacturer received for its "LPBF-matched Thoracolumbar Artificial Vertebrae" earlier this year.

The WedoCage features a porous 3D printed structure, which is designed to facilitate early osseointegration and stability for the patient. BLT says it worked with Wedo’s R&D team to optimise the print process, from parameters to heat treatment, and meet Wedo's design requirements. The company describes the device as a complicated part with extensive overhangs, and demanding requirements for process parameters and support structures. BLT also notes that the mechanical performance of the WedoCageT, coupled with its Truss + Micro-porous structure design, ‘strikes a balance between low elastic modulus and high fatigue performance.’

Since 2019, WedoCage is said to have undergone prospective, randomised controlled clinical trials in more than 10 research hospitals in China. The results of the study showed that the fusion effective rate of the HA-Coated Porous Titanium Fusion Device at 6 months postoperatively was 97.10%, surpassing the fusion success rate of PEEK Fusion Devices at the same time, which stood at 85.29%. BLT says no product-related adverse events were observed during the trial period.

With the launch of this latest device, BLT says it plans to explore further collaborations with Wedo. It follows a year of continued growth for the company, which reported its "strongest ever" year to date with machines now sold into over 20 countries. In the last 12 months, BLT has added several new machines to its portfolio including the large BLT-S800 laser powder bed fusion system, which features a huge 20-laser capacity and launched at TCT Asia. Potentially leading the multi-laser trend in additive manufacturing, the company also introduced the BLT-S1500, a huge metal 3D printer which features 26 lasers and a build volume of 1500 × 1500 × 1200mm (W × D × H).