Polyethylene glycol (PEG) is a synthetic polymer widely used in the biomedical field, known for its colorless, odorless, low-toxicity, and low-immunogenicity properties. With excellent water solubility and biocompatibility, PEG is not only ideal for enhancing drug efficacy and prolonging its action but also widely used in medical-grade applications. These high-purity, low-dispersity PEG materials with precise molecular weights are FDA-approved for safe injection into the human body.

Moreover, PEG-based hydrogels have demonstrated exceptional performance in various surgical scenarios, including wound adhesion, hemostasis, leak prevention, and adhesion barrier applications. They also serve as alternatives to plant-, animal-, or human-derived materials in the production of implantable medical devices.

Characteristics and Applications of PEG Hydrogels

Hydrogels are unique soft, wet materials formed by hydrophilic polymers cross-linked into a three-dimensional network. These structures can swell significantly in water without dissolving, exhibiting properties like flexibility, elasticity, and excellent biocompatibility. In recent years, hydrogels have gained significant attention for their potential applications in biosensing, drug delivery, tissue engineering, and soft robotics.

As a leading biomaterial, PEG hydrogels integrate biophysical and biochemical cues while preventing non-specific protein adsorption. Depending on specific requirements, these hydrogels can be tailored for various uses, such as leak sealing, wound closure, hemostasis, or organ adhesion prevention during surgeries. Additionally, PEG hydrogels can act as drug delivery systems, gradually releasing embedded drugs to achieve targeted therapeutic effects. With their low toxicity, high biocompatibility, and biodegradability, PEG hydrogels offer immense potential in numerous medical applications.

Medical devices primarily utilize multi-arm PEG derivatives due to their larger relative molecular weight, which enables hydrogel formation. These hydrogels provide excellent water resistance and tissue activity, making them suitable for use in hemostatic and tissue-isolating gel-based medical devices. Such devices degrade gradually in the human body and are eventually excreted entirely, ensuring both safety and effectiveness.

FDA Approved PEG Hydrogel Products

Several leading companies worldwide have introduced medical devices based on PEG hydrogel.

Table: FDA-Approved PEG Hydrogel Medical Devices

Three Major Applications of PEG Hydrogels

1. Surgical Sealing and Hemostasis

PEG hydrogels are widely used in various surgical fields, including ophthalmology, neurosurgery, and thoracic surgery. Applied in spray form, they quickly crosslink with proteins on tissue surfaces, forming a strong adhesive layer that stops bleeding and reduces infection risk. Additionally, the thin layer formed on organ surfaces effectively prevents post-surgical adhesions. Thanks to their excellent biocompatibility, PEG hydrogels naturally degrade and are safely excreted from the body after completing their function.

Baxter's CoSeal: CoSeal is made of polyethylene glycol (PEG) and polyethylene. When sprayed onto a tissue surface, it quickly reacts with the tissue proteins to form a strong adhesive bond. This fast sealing action effectively closes blood vessel sutures and helps reduce air leaks during lung surgeries.

Figure 1. CoSeal Mechanisam of action

Medtronic's DuraSeal: DuraSeal is a sealant designed for neurosurgery to prevent cerebrospinal fluid (CSF) leaks after dura mater sutures. It combines a 4-arm PEG solution and a lysine solution, which form a hydrogel when sprayed on the surgical site. This hydrogel seals the area and naturally breaks down in 4–8 weeks. DuraSeal offers strong adhesion and reduces CSF leaks to just 25% of the rate seen with traditional fibrin glue. Clinical studies showed a 98.2% success rate with only a 4.5% post-operative leak rate, proving its high effectiveness.

2. Tissue Spacing for Radiation Therapy

PEG hydrogels are also making significant advancements in radiation therapy. By injecting hydrogels, target organs can be separated from surrounding healthy tissues, reducing radiation exposure to healthy areas.

SpaceOAR, launched in 2015, is the first FDA-approved hydrogel spacer for prostate cancer radiation therapy. Injected as a liquid, it forms a buffer  between the prostate and rectum, creating 1.3 cm of space to reduce radiation to the rectum and lower the risk of damage. Clinical studies show it cuts rectal injury from 90% to 13.6% and reduces late-stage toxicity by 73.5%, significantly improving patient safety.

Figure 2. SpaceOAR

3. Hydrogel-Based Dermal Fillers

PEG derivatives have also demonstrated great potential in the development of dermal fillers. PEG derivatives are safe and non-toxic polymers. Using them as crosslinking agents helps reduce the potential toxicity of the product. When PEG derivatives are combined with hyaluronic acid, they form a strong, three-dimensional structure that provides lasting support and better adhesion, preventing displacement after implantation.

Future Directions

The applications of PEG hydrogels are continually expanding, including:

• ◆ Development of absorbable drug delivery systems

• ◆ Antibacterial gels for treating eye diseases

• ◆ Self-healing hydrogels for vascular regeneration

• ◆ Novel biomaterials for accelerating wound healing in diabetic patients

Additionally, PEG hydrogels are gaining traction in cutting-edge fields such as 3D cell culture and tissue engineering. Their unique properties position them as indispensable materials in modern medical technology, paving the way for advancements in healthcare innovation and development.

Huateng Pharma is a company specializing in the research, development, production and sales of polyethylene glycol and its active derivatives. We provide high-purity multi-arm PEG products, such as 4-ArmPEG-SG, 4-ArmPEG-SS, 8-ArmPEG-SG, 8-ArmPEG-SS for use in hydrogels. We have a large amount of stock, and can also provide the quantity from g to kg according to the needs of customers.