BioSpectrum Asia

Advancing embolizati­on W TH P R D AT


What makes purified gelatin the biomateria­l of choice for embolizati­on?

Embolizati­on, a medical procedure that involves intentiona­lly blocking blood vessels or abnormal tissue growth, requires a biomateria­l that possesses specific properties to ensure its effectiven­ess and safety.

Three key reasons why purified gelatin has emerged as the preferred biomateria­l for embolizati­on: 1. erived from the natural protein collagen, gelatin is inherently biocompati­ble with the human body meaning it is less likely to trigger immune responses or cause adverse reactions, promoting better patient outcomes. It is also biodegrada­ble, meaning it breaks down naturally in the body over time, minimizing the risk of longterm complicati­ons associated with permanent implants.

2. Gelatin offers a precise degradatio­n rate that can be tailored based on the specific needs of the procedure. This controlled breakdown ensures that the embolizing material is gradually replaced by natural tissue as the body heals, preventing complicati­ons and allowing for a predictabl­e clinical outcome.

3. Gelatin can be easily molded into different shapes and sizes, including microspher­es, which are commonly used in embolizati­on procedures. This flexibilit­y in shaping and control over particle size allows for customizat­ion of the embolizing agents, enabling physicians to target specific vessels or tissues more accurately.

How is gelatin advancing embolizati­on applicatio­ns?

Typically, embolizati­on is achieved using materials like coils, particles, or liquids to block or reduce blood flow in specific blood vessels or tissues. In recent years, new types of gelatin-based embolic materials have become an increasing­ly popular choice, offering many advantages. Thanks to its mechanical versatilit­y, gelatin can be used in either microspher­es or gel formats and to treat a wide range of conditions such as arterioven­ous malformati­ons, tumors, and aneurysms.

The recent availabili­ty of improved gelatinbas­ed biomateria­ls with customizab­le properties, consistent quality, and proven biocompati­bility, is providing a new, reliable solution for pharmaceut­ical manufactur­ers and medical profession­als seeking the most effective embolizati­on materials. For example, Rousselot s X-Pure gelatins are currently used in approved and marketed medical devices in the United tates and Asia. We are seeing growth in the developmen­t of new gelatin-based embolic devices in other markets such as Asia, which are rapidly expanding onto the global stage.

How to choose a gelatin for embolizati­on?

While gelatin is a preferred biomateria­l for embolizati­on, it is not without its challenges. electing the right biomateria­l from the start of the R& process is key to achieving success. ere are the most important features to look out for when selecting a gelatin for embolizati­on

 Customizat­ion: Tailoring gelatin properties to meet the specific requiremen­ts of different embolizati­on procedures can be time-consuming and requires careful formulatio­n and testing. Choosing a gelatin supplier that offers customized gelatin ensures seamless product manufactur­ing and optimal performanc­e.

Degradatio­n Rate Control: The degradatio­n rate can be tailored based on the specific needs of the product developed for the embolizati­on procedure, preventing complicati­ons and allowing for predictabl­e performanc­e.

Consistenc­y: Ensuring consistent properties in gelatin microspher­es or embolic agents is crucial. ariability in gelatin properties can lead to unpredicta­ble results, making quality control and standardiz­ation essential.

Purity: Choosing purified gelatins with low levels ofendotoxi­ns helps to ensure safe and effective medical devices.

Availabili­ty and Sourcing: /ack of availabili­ty of high-quality gelatin for medical use can impact the consistenc­y and reliabilit­y of the embolic material. Choosing a well-establishe­d gelatin supplier with a solid track record and a secure supply chain is essential to ensure a reliable and stable source of biomateria­ls.

Compatibil­ity: Gelatin can be engineered to be compatible with various imaging modalities, allowing interventi­onal radiologis­ts to visualize the embolic material s precise location during the procedure. This real-time imaging can enhance the accuracy and safety of embolizati­on.

Documentat­ion: The new European 0edical evice Regulation (0 R) requires rigorous documentat­ion, quality assurance, and product performanc­e assessment­s. All Rousselot products come with supporting documentat­ion for compliance of medical devices with the new 0 R requiremen­ts ((EU) 201 / ), documented traceabili­ty up to the farm (I O 22 2-2), validated viral inactivati­on (I O 22 2-3) and IPEC G0P Compliance.

Why choose X-Pure?

Rousselot s X-Pure gelatines have been designed to address the specific requiremen­ts of embolizati­on procedures. Offering customizab­ility, purity, and consistenc­y, X-Pure serves as the ideal foundation for creating various embolic agents like gelatin microparti­cles/microspher­es and hydrogels. X-Pure is compatible and easily blended with a wide variety of different drugs, cells, and molecules for accurate drug delivery and imaging. As such, X-Pure can support a wide range of embolizati­on applicatio­ns, including transarter­ial embolizati­on (TAE), transarter­ial chemoembol­ization (TACE), and radioembol­ization.

Rousselot s X-Pure range has been developed to ensure maximum quality and safety, with endotoxin levels of <10 endotoxin units (EU)/g. All X-Pure gelatins support regulatory compliance with key internatio­nal guidelines. This includes traceabili­ty, readily available documentat­ion, and validated viral safety.

Rousselot offers tailored gelatin solutions

With 130 years of gelatin expertise, Rousselot has a deep understand­ing of the properties and functional­ities of gelatin. We listen carefully to our customers to understand their embolizati­on challenges and provide expert solutions tailored to their needs. From choosing the right product all the way through to testing and optimizing a formulatio­n, we offer support to help our customers get the most from our products and achieve their goals.

Through our unique offering of customized gelatins, comprehens­ive technical support, and collaborat­ive developmen­t for innovative embolizati­on techniques, we aim to help our customers reach the market as quickly as possible, delivering speed without compromisi­ng on quality.

Advancemen­ts and future directions

Embolizati­on was introduced more than 0 years ago as a therapeuti­c modality, but it has seen significan­t growth in the last decade. The list of indication­s continues to grow, with embolizati­on for fibroids, prostate, and some types of liver tumors offering new treatments for patients in recent years. As technology, devices, and imaging quality continue to improve, we are likely to see novel applicatio­ns and better patient outcomes in different diseases.

Interdisci­plinary collaborat­ion between biomateria­l scientists, interventi­onal radiologis­ts, & medical profession­als is driving innovation in gelatin-based embolizati­on materials. By further refining gelatinbas­ed embolic agents & exploring novel applicatio­ns, the medical community can enhance the safety & efficacy of embolizati­on procedures, ultimately benefiting patients with various vascular conditions.

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