UNISTAT™ Absorbable Surgical Haemostat Matrix
UNISTAT™ Oxidized Regenerated Cellulose (ORC) is a sterile, bio-absorbable, warp-knitted hemostatic fabric manufactured from high-purity plant-derived alpha-cellulose. Engineered specifically for intra-operative bleeding control, UNISTAT™ provides immediate physical closure for capillary, venous, and small arteriolar hemorrhages when conventional suturing or electrocautery is ineffective or impractically slow.
Manufactured in an ISO 13485 cleanroom facility in Bengaluru, India, UNISTAT™ undergoes controlled chemical oxidation to form polyanionic carboxylic acid moieties. This structure delivers dual action: rapid gel-mediated blood clotting within 2–8 minutes and inherent low-pH antimicrobial defense against hospital-acquired pathogens.
Mechanism of Action & Clinical Advantages
Engineered to satisfy stringent surgeon requirements across neurosurgical, cardiovascular, orthopedic, and general surgical procedures.
Rapid Clot Formation
Upon contact with whole blood, UNISTAT™ absorbs fluid quickly and swells into a gelatinous mass. This matrix binds hemoglobin to form a dark artificial clot, stabilizing the surgical site and halting bleeding within minutes.
Complete Tissue Absorption
Naturally degraded via enzymatic breakdown and macrophage activity, UNISTAT™ is fully bio-absorbed within 7 to 14 days without inducing granuloma formation, fibrotic encapsulation, or permanent tissue adhesion.
Inherent Antimicrobial Protection
The chemical oxidation process maintains a low acidic micro-environment (pH ~2.5–3.5). In vitro testing confirms bactericidal activity against Gram-positive and Gram-negative pathogens including MRSA, MRSE, and E. coli.
Superior Handling & Conformability
The soft, warp-knitted structure allows easy cutting, folding, or wrapping around irregular anatomical structures. It holds its structural integrity without fraying or sticking to gloved hands or surgical forceps.
Biocompatible & Non-Antigenic
Formulated from highly purified plant cellulose, UNISTAT™ eliminates human- or animal-derived pathogen transmission risks (BSE/TSE-free), ensuring exceptional patient safety profiles.
Hermetic Barrier Packaging
Each unit is individually sealed in an airtight, puncture-resistant aluminum foil primary pouch inside protective secondary packaging, ensuring sterility and stability across tropical global transport conditions.
UNISTAT™ Product Variants & Technical Parameters
Available in multiple structural forms to accommodate diverse surgical techniques, endoscopic application, and cavity packing.
UNISTAT™ Original
Standard warp-knitted fabric for general surgical oozing, abdominal wall repair, and solid organ resection.
UNISTAT™ High Density
Thicker, dense knitted structure designed for heavy venous bleeding, orthopedic bone surface bleeding, and sternotomy.
UNISTAT™ Fibrillar
Layered, tufted fibrous fleece that can be peeled in thin layers for precise placement in deep, irregular cavities or neurosurgery.
UNISTAT™ Non-Woven
Needle-punched non-woven pad offering high absorbency and high tensile strength for laparoscopic trocar site management.
| Technical Parameter | UNISTAT™ Standard Specification | Compliance Reference |
|---|---|---|
| Chemical Structure | Oxidized Regenerated Cellulose (Carboxylic Acid Content 16% – 24%) | USP / EP Monograph |
| Appearance | White to pale yellow sterile fabric ribbon / sheet | In-house Quality Protocol |
| Hemostasis Time | 2.0 to 8.0 Minutes post-application | In vivo / In vitro Validated |
| In Vivo Resorption Time | 7 to 14 Days (Complete Macrophage Clearance) | ISO 10993-6 Implantation Test |
| Bacterial Endotoxin Limit | < 20 EU / device (LAL Test Certified) | USP <85> / ST72 |
| Sterility Assurance Level | SAL 10⁻⁶ via Gamma Radiation Sterilization | ISO 11137-1 / ISO 11137-2 |
| Manufacturing Standard | Cleanroom Class 100,000 (ISO 8 Equivalent) | ISO 13485:2016 QMS |
OEM & Contract Manufacturing Services for ORC Haemostats
Universal Sutures is a strategic OEM supplier to healthcare brand owners, pharmaceutical companies, and regional medical distributors worldwide. We provide comprehensive private-label solutions tailored to your market's regulatory and commercial requirements.
- Custom Sizes & Dimensions: From standard 5cm × 7.5cm sheets to custom endoscopic strips and cavity rolls.
- Bespoke Packaging & Labeling: Multi-lingual foil printing, custom box artwork, IFU translation, and EAN/GS1 barcoding.
- Regulatory Dossier Support: Full technical documentation (CE, ISO 13485, EU MDR Technical Files, Stability Data) provided for fast in-country health authority registration.
- Reliable Export Logistics: Temperature-controlled international dispatch with batch certificate of analysis (CoA) released with every shipment.
Frequently Asked Questions for Medical Procurement
Essential clinical, technical, and regulatory answers for hospital buyers, importers, and device distributors.
How does UNISTAT™ compare to bovine gelatin or collagen-based hemostatic agents?
Unlike bovine or porcine gelatin/collagen sponges, UNISTAT™ is derived from 100% plant cellulose. It eliminates risks of animal-borne pathogen transmission (such as BSE/TSE) and religious/cultural dietary constraints. Furthermore, UNISTAT™ generates an acidic micro-environment that provides natural antibacterial properties, whereas collagen sponges can act as a substrate for bacterial growth if infected.
Can UNISTAT™ be left permanently inside the patient after wound closure?
Yes. UNISTAT™ is intended as an implantable absorbable hemostat. However, sound surgical practice dictates that excess material not required for hemostasis should be removed prior to surgical closure, especially in confined bone spaces (e.g., optic chiasm, spinal cord) to prevent tissue pressure prior to total absorption.
What surgical specialties frequently utilize UNISTAT™ ORC?
UNISTAT™ is widely deployed in Neurosurgery (dural oozing, brain parenchyma), Cardiovascular Surgery (vascular suture lines), General & Abdominal Surgery (liver resections, gallbladder beds), Gynecology (myomectomy beds), Urology (prostatectomy), and Trauma Surgery.
What storage conditions are recommended for international shipping and warehousing?
UNISTAT™ should be stored in its sealed original packaging in a cool, dry place away from direct sunlight and excessive heat (controlled room temperature below 30°C / 86°F). The multi-layer aluminum foil primary pouch prevents moisture ingress and degradation.