Nexsphere™ is a gelatin based hydrophilic microspheres for endovascular embolizations, that is used together with a contrasting agent during vascular embolization for therapeutic and treatment purposes. It is injected into the blood vessel through a microcatheter in order to temporarily occlude the blood vessel. Nexsphere™ is an resorbable microsphere that exhibits embolic performance in a variety of indications with uniform spherical particles, high elasticity and strong cohesion.
OverviewIndication
Use in embolization of blood vessels to occlude blood flow for therapeutic purposes
Indication
![이미지](http://nextbiomedical.co.kr/images/content/product02_indication_img01.jpg)
Liver Cancer
![이미지](http://nextbiomedical.co.kr/images/content/product02_indication_img02.jpg)
Uterine Fibroids
![이미지](http://nextbiomedical.co.kr/images/content/product02_indication_img03.jpg)
Prostatic Hyperplasis
![이미지](http://nextbiomedical.co.kr/images/content/product02_indication_img04.jpg)
Osteoarthritis
![이미지](http://nextbiomedical.co.kr/images/content/product02_indication_img05.jpg)
Arterial Bleeding
Features
![아이콘](http://nextbiomedical.co.kr/images/content/product02_features_img01.png)
Uniform Spherical Particles
![아이콘](http://nextbiomedical.co.kr/images/content/product02_features_img02.png)
Minimization of side effects
without crosslinking agents
![아이콘](http://nextbiomedical.co.kr/images/content/product02_features_img03.png)
Injection container that prevents contamination
Vial designed for contamination prevetion (Design Patent : 3009879200000)
![아이콘](http://nextbiomedical.co.kr/images/content/product02_features_img04.png)
Various size selections depending
on the patient condition
How to use
![이미지](http://nextbiomedical.co.kr/images/content/product02_use_img01.jpg)
Inject saline into the Nexsphere™ vial using a luer lock syringe and then shake to disperse and hydrate the microspheres
![이미지](http://nextbiomedical.co.kr/images/content/product02_use_img02.jpg)
Slowly inject the contrast medium into Nexsphere™ vial with saline using a luer lock syringe, and shake for minutes to mix the contents.
![이미지](http://nextbiomedical.co.kr/images/content/product02_use_img03.jpg)
Transfer the mixed contents to a syringe.
![이미지](http://nextbiomedical.co.kr/images/content/product02_use_img04.jpg)
Inject the mixed Nexshpere™ contents into the lesion via a stanard catheter
Best practice
It is recommended to wait for hydration depending on sizes after adding saline to the Nexsphere™ vial and shaking.
Inject contrast medium into the vial containing saline and Nexsphere™
Product highlights
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Gelatin based resorbable microspheres capable of temporary embolization
Nexsphere
Gelatin sponge
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High elasticity and cohesive force1)
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Absorbable within 2 hours after embolization 2)
Histology of Rat Liver 3)
Embolization
2 hours after embolization
Non-resorbable product
Non-resorbable product
Angiography of Porcine Kidney 3)
Pre-embolization
Embolization
Recanalization 2 hours after embolization
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Effective and safe way to relieve pain and promote functional recovery in patient 4)
No adverse events including skin discoloration 4)
Post-marketing clinical trials in progress
- - Seoul Asan Medical Center in Korea : A prospective, comparative study is currently ongoing to evaluate safety and efficacy or Nexsphere with different absorbable times for transcatheter arterial chemoembolization for hepatocellular carcinoma. (150 patients)
- - Severance Hospital in Korea : Comparison of pain after uterine artery embolization using spherical gelfoam or tris-acryl gelatin microsphere in patients with symptomatic fibroids: A Prospective, Randomized Study. (60 patients)
Preclinical outcomes
porcine kidney embolization 5)
Before
embolization5mins after
embolization1week after
embolization2week after
embolization4week after
embolization
Ordering information
Ordering Code | Size (㎛) |
Quantity (㎎) |
---|---|---|
UIGB 100 | 100-300 | 300 |
UIGB 300 | 300-500 | 300 |
UIGB 500 | 500-700 | 300 |
UIGB 700 | 700-900 | 300 |
Nexsphere-H | 100-300 | 250 |
Nexsphere-F | 100-300 | 200 |
References
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- 1) In-house elasticity and cohesion tests were performed on monolayers of microspheres with a texture analyzer.
- 2) In house in-vitro degradation test showed that Nexsphere-F was degraded in 37°C of warm saline within 2 hours.
- 3) Animal studies were conducted with Nexsphere-F by external non-clinical CRO in Korea. Animal study results may or may not be indicative of clinical outcomes in humans.
- 4) Jae Hwan Lee et al. Short-term Results of Transcatheter Arterial Embolization for Chronic Medical Epicondylitis Refractory to Conservative Treatment : A Single-Center Retrospective Cohort Study. Cardiovasc Intervent Radiol. 2021 June 4.
- 5) Animal studies were conducted with Nexsphere by external non-clinical CRO in Korea. Animal study results may or may not be indicative of clinical outcomes in humans.