TUV CE0123 Sterile Sinus Balloon ostial Dilation SBD System micro invasive Sinuplasty Surgery Balloon Catheter

Sinus Balloon Dilation System
Product Description
Sinus balloon dilation is a procedure involving placing a tiny and flat balloon in the sinus ostium with the assistance of nasal endoscope. When the balloon inflates, the sinus passage which was contracted or blocked due to the inflammation, will be restored to normal or slightly enlarged , so that the air enters into the sinus smoothly, and later with the saline flushing in the sinus cavity, the treatment reaches its intended outcomes. Studies show that the procedure can successfully dilate the sinus ostia and spaces without causing any complication or adverse reaction and its safety is also verified by the CT scans before and after the procedure, multi-dimension endoscopic and general examinations .
Intended use: dilate the narrow or blocked maxillary sinus, frontal sinus and sphenoid sinus, or adjunctive to medication or functional endoscopic sinus surgery (FESS) .
Indication: chronic rhinosinusitis(CRS)patients who fails medical management such as antibiotics, local hormones, or antiallergic medication, but in need of nasal endoscopy; and also those in the effective stage after the standardized treatment, but the sinus CT manifests abnormal, and sinusitis occurs more than 3 times a year.
Contraindications: extensive nasal polyps; multiple records of nasal surgery, extensive hyperosteogeny, nasal tumors, ciliary function loss, cystic fibrosis, clear anatomical abnormalities, and inflammation in acute stage.
Work Theory
Product structure and introduction
Sinus balloon catheter
1.The balloon features with high pressure resistance and low inflation
2.Design of tough distal end and soft proximal end provides the catheter with a good performance of pushing forward and frontal bending.
3.The radiopaque marker on the balloon enables the balloon operating with the imaging equipment in complicated cases.
Sinus Guide Catheter
Angles of the Sinus guide catheter includes 0°,30°,70°,90°,110° suitable for the different sinus ostia.
Irrigation Catheter
intended to irrigate from within a target sinus for therapeutic procedures and to facilitate diagnostic procedures.
Guide Wire
Illuminating wire is intended to position the targeted sinus cavity.
Guide Handle
Intended to create an extension from a Sinus Guide Catheter
Models
ModelsSinus Balloon CatheterGuide CatheterGuide WireIrrigation CatheterGuide HandleComparison with the traditional sinus surgery
Traditional Sinus Surgery
Sinus Balloon Dilatation
Damages on the sinus drainage passage and mucosa cilia system, as a portion of normal anatomical structures are excised
No incision and no damage to any bone or structures, mucosa cilia system remains intact.
Possible complications
No complication and phenomenal treatment outcomes
Extensive wound and huge pain for the patients
Minimal invasiveness, less bleeding, less pain
Long recovery time
Fast recovery. Patient usually recovers within 24h after the procedure.
Long surgery time, high risk
Easy operation, short surgery time.
Packaging & Shipping
Product
Size
Weight
Balloon Catheter
42x9x2 CM(box)
0.0624 KG
Guide Catheter
22X9X2CM(box)
0.0370 KG
Guide Handel
22X9X2CM(box)
0.0378 KG
Irrigation Catheter
48X9X2CM(box)
0.0710 KG
Guide Wire
28.5X25.5X1CM(box)
0.094 KG
Connector
10x9CM(pouch)
0.0083KG
Pump
26X12.5X7CM(box)
0.318KG
Whole set
50.5X28X10CM(box)
1.700 KG
Company Information
Established on Feb 18th 2014, later among the first group of hi-tech enterprises in 2017, Guangdong Kangerle Medical Equipment Co.,Ltd (Kangerle Medical) set its production base in Pengjiang District, Jiangmen and operation center in Baiyun District, Guangzhou.
Owning its independent intellectual property, Kangerle is a hi-tech enterprise specialized in high-value medical consumables and integrating with the R&D, production and sales of medical equipment.
Kangerle Medical passed the audit of Guangdong Food and Drug Administration, and obtained the production license for medical devices (Certificate no.20142584 issued by Guangdong Food and Drug Administration on the approval of the medical equipment production); later passed the audit by TUV sud, and obtained the certificate of Quality System ISO13485-2016, CE MDD product certificates of
So far the products of Kangerle Medical range from the section of ENT, Obstetrics, Cardiology, to general surgery, including such following registered devices as Eustachian tube balloon dilatation catheter, Sinus balloon dilatation system, disposable gastric tube, disposable cervical ripening balloon catheter, disposable vacuum wound drainage kit, disposable Balloon uterine stent, and disposable endometrial sampler. GMP compliant production base is equipped with the Class 10k clean room, Class 10k(partial Class 100) sterile test room, bacteria lab, positive control lab and state-approval EO sterile equipment, and professional medical device production and test instruments.
Kangerle Medical’s quality management system complys with ISO13485 and GMP which puts the production procedure in effective control and ensures the finished products meet the registered standards.
Equipped with high quality production lines, advanced production and test instruments, and professional R&D and QC team, Kangerle medical is able to provide every medical institutes with high quality products and high efficiency service.
Kangerle Medical holds the management and business principle of Manage with care, manufacture with minds, service with heart, devotes to the research, production and sales of hi-tech medical equipment, and provides the market with the most cost-effective medical equipment.
Company Development
2014: Establishment
2015: Register of Sinus Balloon Dilation System
2016: Approval of Medical Device Production. Register of Disposable Gastric Tube and Disposable Cervical Ripening Balloon Catheter
2017:Register of Disposable Vacuum Would Drain Kit
2018: Register of Guide Needle. Register of Category II Medical Equipment Business License.
2019: Register renewal and adding models of Sinus Balloon Dilation System. Register of Nasal Irrigator and Nasal Guide Kit.
2020: Register of Eustachian Tube Balloon Dilation Catheter. Certificate ISO13485-2016 issued by TUV sud. CE MDD certificate of Sinus Balloon Dilation System, Cervical Ripening Balloon Catheter, and Vacuum Wound Drainage Kit.