Legal and Regulatory

TISSIUM receives FDA approval for vascular sealant polymer

Paris-based MedTech company TISSIUM has received approval from the Food and Drug Association (FDA) for its Investigational Device Exemption (IDE) application for its vascular sealant.

The IDE approval paves the way to a clinical trial launch in the U.S. for the material, which makes up part of TISSIUM’s proprietary polymer platform for therapeutic applications.

“We are pleased to receive this approval from the FDA as it represents a key milestone that accelerates the development of our vascular indication and triggers the further expansion of our broad platform,” said Christophe Bancel, TISSIUM CEO.

TISSIUM's viscous pre-polymer is activated on-demand using visible blue light. Image via TISSIUM.
TISSIUM’s viscous pre-polymer is activated on-demand using visible blue light. Image via TISSIUM.

TISSIUM’s vascular sealant

Designed for use in peripheral vascular surgeries, TISSIUM’s vascular sealant is engineered to prevent post-operative bleeding and speed up hemostasis, the first stage of wound healing. The biocompatible polymer offers surgeons a simple preparation and application process, complementing the use of sutures to aid in full surgical closures of vascular vessels.

Based on a biocompatible and biodegradable pre-polymer, poly(glycerol sebacate acrylate), which is activated on-demand via light, the vascular sealant can be applied in wet and dynamic environments with minimal washout. The material’s biomorphic properties enable it to conform to and integrate with surrounding tissue to facilitate tissue reconstruction. The polymer building blocks can also be adjusted to match tissue-specific requirements for various applications.

The vascular sealant received its first CE Mark in 2017, around the same time TISSIUM expanded its platform into 3D printing. In 2019, an additional CE Mark was granted for the sealant in pre-filled syringe format.

TISSIUM’s biopolymer platform

The IDE approval will enable TISSIUM to continue expanding its existing platform of fully synthetic, biomorphic, and programmable polymers. The platform uses proprietary technology initially developed at the Massachusetts Institute of Technology (MIT) and Harvard Medical School by professors Robert Langer and Jeffrey Karp, who co-founded TISSIUM in 2013.

The polymer technology is based on a combination of naturally occurring compounds such as glycerol and sebacic acid. A viscous pre-polymer can be precisely applied to tissues during surgical procedures, achieving minimal displacement of bodily fluids. Visible blue light activates the pre-polymer on-demand to create an adhesive, elastic bond with the underlying tissue.

The pre-polymer can also be used as a resin to build high-resolution 3D printed devices. Currently, the firm is working on the development of sutureless nerve reconstruction surgical scaffolds, through combining a 3D-printed implantable device and an on-demand activated adhesive.

“We will continue to execute on our strategy to build devices using our core polymer technology and offer applications across multiple therapeutic areas, such as peripheral nerve and hernia repair where we have recently started development,” Bancel added.

TISSIUM currently holds 18 patents and has 26 pending, suggesting there are plenty more developments on the way from the firm.

TISSIUM’s pre-polymer is applied to tissues during surgical procedures with minimal displacement of bodily fluids. Image via TISSIUM.

3D printing for surgical procedures

3D printing has been used within the medical sector for the planning and preparation of surgical procedures for time. Examples include researchers from Tampere University experimenting with a new method of nasal surgery preparation, the use of 3D printed models to practice delicate surgeries by the Department of Vascular Surgery at University Hospital Mainz in Germany, and in the preparation of a successful nine-hour operation to separate conjoined twins.

More recently, the exploration of 3D printing to create end-use medical devices is gaining more traction as biocompatibility properties and materials improve. Turkish university researchers have assessed the viability of using 3D bioprinting technology for potentially implantable devices, while LOGEEKs Medical Systems (MS) announced the completion of two surgery operations using its customized 3D printed implants.

Elsewhere, Children’s Healthcare of Atlanta and the Georgia Institute of Technology successfully used 3D printed tracheal splints in the pediatric surgery of a 7-month old patient, while 3D printed breast implants from BellaSeno achieved ISO 13485 certification and commenced clinical trials last year.

Most recently, the Swiss Federal Institute of Technology Lausanne has developed a mechanical microdevice capable of biopsy and drug delivery when implanted in human skin, and 4WEB Medical has added a Stand-Alone Anterior Spine Truss System to its 3D printed spine implant portfolio.

3D printed tracheal splints. Photo via Georgia Tech.
3D printed tracheal splints. Photo via Georgia Tech.

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Featured image shows TISSIUM’s viscous pre-polymer is activated on-demand using visible blue light. Image via TISSIUM.

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