What is SeraSeal™?
SeraSeal™ is an innovative primary haemostatic agent designed to stop bleeding on contact and within seconds for arterial haemorrhages. It is comprised of agar and bovine factor proteins IIa VIIa and IXa and Xa and acts as a catalyst in the clot formation process. This single-component system can tackle any bleeding situation with the potential to save many lives. When seconds count, SeraSeal™ can make the difference between life and death.
The first stage of trauma leads to haemorrhage and inflammation. Haemorrhages lead to shock and resuscitation. And finally, all adverse events- haemorrhage; inflammation; shock; and resuscitation on their own all lead to coagulopathy.
Coagulopathy can lead to haemorrhage, only to continue the cycle of haemorrhage. Death is the result of hemorrhage is not arrested. SeraSeal™, when used with other surgical modalities, can effectively control bleeding in level III and level IV type haemorrhages in seconds and can use in emergency and trauma cases. Clinical studies and clinical use have demonstrated SeraSeal™’s unique formulation to be effective in a wide range of coagulopathies. When SeraSeal™ is applied to a wound, it does not create inflammation or damage to the tissues allowing the wound healing to occur sooner. A one-component haemostatic agent SeraSeal™ requires no mixing or preparation and is available in multiple delivery systems to administer any wound to any part of the body.
By controlling bleeding, it reduces the substantial need for blood transfusions, thereby, reducing risk and cost to the patient. In addition, cost savings are realized through SeraSeal™ by reducing surgical time, wherein in some cases, the savings are as much as 50% and shorter hospital stays.
How SeraSeal™ Works?
There are two distinct pathways for fibrin clot formation – the extrinsic and intrinsic pathways. The vitamin K factors in SeraSeal™ support both clotting pathways to form a fibrin clot in seconds instead of minutes. The fibrin clot adheres to the initial agar barrier reinforcing the physical sealant- “The SeraSeal™ clotting cascade”. The effect on the coagulation cascade system is on blood outside the injured blood vessel and not on the intravascular system.
The intrinsic pathway & the extrinsic pathway, where both the extrinsic and intrinsic pathways share the common pathway to form a fibrin clot, SeraSeal™ catalyzes these specific factors: factors IIa, VIIa, IXa, and Xa. Factor VIa is activated by releasing thromboplastin from the blood vessels, not from SeraSeal™, and before SeraSeal™ is applied to the wound. It is SeraSeal™’s ability to bridge any point in the normal coagulation cascade system that is inhibited by anticoagulation medication such as heparin or warfarin or a factor deficiency.
Agar in SeraSeal™ will cross-link with the ions of platelet phospholipids and cations from amine groups in and fibrinogen fibrin monomers and tissue proteins to form a platelet barrier over the wound. In addition, platelet inhibitors do not blind to the phospholipids on the platelet surface. Therefore, agar is effective in the presence of platelet inhibitors.
How Are We Different?
SeraSeal™ is superior in efficacy and safety to arrest bleeds over current hemostatic and tissue sealant products being used. SeraSeal™ can reduce surgical time by as much as 50% in some cases, and blood transfusion by 90% (in upto 40% surgical procedures), resulting in substantial cost savings. In addition, SeraSeal™ has multiple delivery systems. It can be delivered by a syringe, spray, foam, scope, trochar, catheter, trauma dressing, battlefield dressing, surgical sponges, dental compresses, swabs, and bandage strip. These delivery systems substantially expand the hemostatic market to include hospitals, ER/trauma centers, medical and surgical clinics, private practice, dentistry, veterinarian medicine, paramedics, military, law enforcement, and over the counter products in the form of first-aid products for the home, business, recreational and sporting events.
- SeraSeal™ does not obstruct the view of the bleeding site
- Excellent for highly vascular organs
- Excellent at the point of anastomosis
- SeraSeal™ has multiple delivery mechanisms, including portal wounds
- SeraSeal™ is active in the presence of anticoagulants
- Active in the presence of factor deficiencies
- It has no limit to age or tissue type
- No limit to a market segment
- SeraSeal™ has no side effect’s and or adverse reactions
- It has Specific Gravity of 1.02
No preparation is required for the patient before application. Reduces blood transfusion up to 90 percent in upto 40% surgical procedures.
A revolutionary medical innovation stops bleeding in seconds. SeraSeal™, a primary
haemostatic agent, has various advantages.
SeraSeal™ is the World’s First and Only Primary Hemostatic Agent
Effective on all forms of coagulopathy: anticoagulant drugs, platelet inhibitors, factor deficiency
SeraSeal™ can be applied to all tissues, including the bone marrow
Multiple delivery systems: syringe, spray, foam, scope, trochar, catheter, trauma dressing, battlefield dressing, surgical sponges, dental compresses, swab, and bandage strip
No preparation can be used immediately
Can be used in emergency/trauma cases
Reduces surgical time by as much as 50%
Reduces blood loss by 90% in upto 40% surgical procedures
No loss of tissue or adhesions & promotes healing
Can be used outside of the clinical setting
Can undergo repetitive freeze-thaw cycles without loss of activity
Substantial cost savings through less surgical theatre time, fewer blood transfusions, less anesthesia medication, less pain medication, shorter ICU and hospital stay
SeraSeal™ is an excellent haemostatic agent that works in seconds; its other benefits are:
Excellent for highly vascular organs
Excellent at the point of anastomosis
Reduces surgical time by 50%
90% less blood loss
Active in the presence of anticoagulants
Active in the presence of factor
No limit to age or tissue type
No limit to a market segment
No side effects
It has Specific Gravity of 1.02
Expandable market areas
SeraSeal™ is indicated in all surgical procedures as a primary to hemostasis when control of bleeding by cauterization, ligature, or conventional procedures is ineffective or impractical.
Important Risk Information For SeraSeal™
SeraSeal™ must NOT be injected into blood vessels or allowed to enter blood vessels. This may lead to extensive intravascular clotting or even death.
Frequently Asked Questions
No. SeraSeal™ is a Class D Medical Device. The product is applied topically to the wound, and it is not introduced into the vascular system, nor enters the cell, as per the definition of a drug.
No. The active agent Factor IXa in Seraseal™ compensates for the Heparin effect on the patient’s Factor IX, while Factor VIIa in Seraseal™ compensates for Warfarin inhibition to the patient’s Factor VII, and agar in Seraseal™ attaches to the platelet phospholipids, by-passing the inhibitory sites of platelet inhibitors.
No. The surface can be wet if you can see the point of origin of the bleed.
No, it is not necessary. Hemostasis will still occur within seconds, usually in 2-5 seconds for venous bleeds, 10-15 seconds for small arteries, 25-35 seconds for medium size arteries, and still less than 60 seconds for large arteries.
Yes. It may take a few more seconds to achieve hemostasis, because fibrinogen is a cryo-protein and will begin to precipitate out of solution when the body temperature drops below 350C. Therefore, the fibrinogen level is artificially low, and is less available to form a fibrin clot.
No. There have been no reported adverse effects of Seraseal™. It is estimated that less than 0.05% of the population would be sensitive to SeraSeal™ , and they would be patients sensitive to bovine proteins, and a few lupus patients. Seraseal™ has been applied to more than 1 million applications without a single adverse event. The major reason is, Seraseal™ is applied topically, and is removed by irrigation/suction from the wound site within 1-2 minutes after hemostasis has occurred.
Further, autologous fibrinogen is used to create the fibrin clot to seal the wound.
None. The reason why there has not been a case of post-operative bleed, it is due to the fibrin strands within the initial soft fibrin clot to cross-link with fibrinogen and proteins within the clot, to form a stabilized fibrin clot with strong tensile strength. Once the stabilized clot is formed, the only way for a re-bleed to occur is to physically remove the fibrin clot.
Yes. Children as young as 20 days old have been successfully treated with Seraseal™ in a wide range of surgical procedures.
Yes. By using a laryngoscope, insert a 22 cm atomizer (adult size, 12 cm pediatric size) attached to a 3cc syringe of Seraseal™, down to the base of the esophagus, and as you slowly withdraw the atomizer, spray the wall of the esophagus with Seraseal™ to arrest all of the hemorrhages in one motion.
Yes. A separate canister with its own suction line is required.
Yes. The stabilizers in Seraseal™ allow repetitive freeze-thaw cycles without loosing its activity
A: Since, this is in sterile form, no pathogens involved, no pathogenicity.
A: Since, Seraseal™ is not indicated for intravenous or intramuscular use and doesn’t get into Blood stream. Half Life will not be applicable. What’s half Life? The time taken for the drug to reach 50% of its concentration from the peak level in serum. Seraseal™ is not getting in to serum & acts locally, so there is no question of half-life. Half-life is time taken to reach half original concentration in the body, this applies to drugs which are taken inside the body through various routs like oral, IV or IM.
A: It is recommended to use fresh sterile needle from the sterile pack to reload the Seraseal™ in to vial. And the surface of the rubber stopper of the vial should be cleaned with sterillium / betadine/ chlorhexidine solution. This will avoid any possible contamination.
When we load seraseal™ in syringe and needle, no pathogens will enter through needle. Only if atmospheric air is aspirated, then only pathogens will enter.
Syringes are sterile, they are single use. No question of pathogens as this comes in a sterile pack.