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Baxter Bio Surgery

STOP BLEEDING FAST

COSEAL

Coseal is a biocompatible polyethylene glycol polymer (PEG) that rapidly cross-links with the proteins in tissue to immediately adhere to the area of application. This is ideal during vascular reconstruction when you want to seal potential areas of leakage. Additionally, COSEAL’s adhesion prevention properties make reoperative cardiac procedures easier and faster7

COSEAL [Surgical Sealant] Indications

COSEAL is indicated for use in sealing suture lines along arterial and venous reconstructions and in patients undergoing cardiac surgery to prevent or reduce the incidence, severity and extent of post surgical adhesion formation.

  • Polymerization occurs in approximately 5 seconds1
  • Demonstrated to seal leak pressures of [660 +/- 150] mmHg (in vitro burst test for closure of puncture defects 0.6-0.9 mm diameter in porcine carotid artery, n=4)6
  • Sealing and hemostasis unaffected by patient’s coagulation status1
  • Fully synthetic, glutaraldehyde free8
  • Successfully adheres to synthetic materials5
  • EasySpray application system allows coverage of broad surface areas with maximum product utilization
  • Does not produce an adverse tissue response and resorbs fully in 4 weeks5,1

Potential Application Points

  • For vascular reconstruction sites associated with CABG
  • Arteriotomies/aortotomies
  • Peripheral vascular surgery
  • Aortic root reconstruction
  • Vascular reconstruction associated with heart transplantation
  • Carotid surgery
  • Arteriovenous grafts and shunts
  • Pediatric and adult reoperative procedures or for patients with greater risk of reoperative cardiac procedures

Most Common Surgical Procedures

Surgery
Description
Areas of Application / Rationale
Carotid endarterectomy (CEA) Removal of plaque from the carotid artery in the neck, followed by closure, graft, or patch.    Anastomotic suture-line
Abdominal Aortic Aneurysm(AAA) Repair The AAA repair involves the abdominal aorta extending from the diaphragm to the pelvis where it divides into the common iliac arteries. Depending on the patient’s anatomy, and the location of the aneurysm, the aorta can be reconstructed with a tube graft, an aortoiliac bifurcation graft (Y-graft), or an aortofemoral bypass. Bleeding and/or needle-hole bleeding.
Femoral-Femoral Bypass (Fem-Fem) Femoral-Popliteal Bypass (Fem-Pop) A bypass graft procedure is to provide re-vascularization of blood flow to the lower legs using a graft that bypasses the femoral artery to the popliteal artery or from one femoral artery to the other.
Arteriovenous (AV) Fistula Surgical joining of an artery and a vein under the skin for the purpose of hemodialysis. Sometimes the vessels in the arm are damaged and are not suitable for forming an AV fistula. In these cases, a synthetic graft is used to form the attachment between an artery and a vein.
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APPLICATION
BENEFITS OF USING COSEAL SURGICAL SEALANT IN VASCULAR SURGERY
  Anastomotic Suture Line Sealing

1. COSEAL is a strong, flexible, and completely synthetic sealant used for vascular surgery to achieve adjunctive hemostasis.1,2 COSEAL is strong enough to withstand the pressures of even the largest vessels, with burst pressures 3X that of hypertensive aortic pressure, but also flexible enough to conform to pulsatile anatomy.3
2. COSEAL has been clinically proven to adhere to Dacron, ePTFE grafts and tissue/autologous grafts, which is customary for vascular reconstruction procedures.4-6

 

FLOSEAL

Indications

  • FLOSEAL is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostatic procedure when control of bleeding by ligature or conventional procedures is ineffective or impractical.

Features

  • Works on wet, actively bleeding tissue and conforms irregular wound surfaces 2
  • Proven to control bleeding from oozing to pulsatile flow 1
  • Convenient kit contains all the items necessary for use, including human thrombin, and can be prepared in as short as 2 minutes
  • FLOSEAL can be applied focally or extruded and spread to cover a large area of diffused bleeding
  • FLOSEAL can be applied to both hard and soft tissue 3

Important Safety Information

  • FLOSEAL must not be injected into blood vessels, or allowed to enter blood vessels. Do not apply in the absence of active bleeding. Extensive intravascular clotting and even death may result.
  • Do not use FLOSEAL in the closure of skin incisions because it may interfere with the healing of the skin edges.
  • Do not use FLOSEAL in patients with known allergies to materials of bovine origin.
  • FLOSEAL is made from human plasma. It may carry a risk of transmitting infectious agents, e.g., viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent.
  • FLOSEAL is not intended as a substitute for meticulous surgical technique and the proper application of ligatures or other conventional procedures for hemostasis.
  • The maximum swell volume of approximately 20% is achieved within about 10 minutes. Excess FLOSEAL (material not incorporated in the hemostatic clot) should be removed from the site of application using gentle irrigation.
  • FLOSEAL should not be used in conjunction with methylmethacrylate or other acrylic adhesives.
  • RX Only: For safe and proper use of this device, please refer to full device Instructions For Use.

TISSEEL

About TISSEEL ® [Fibrin Sealant]

TISSEEL is indicated for use as an adjunct to hemostasic procedure in surgeries involving cardiopulmonary bypass and treatment of splenic injuries due to blunt or penetrating trauma to the abdomen, when control of bleeding by conventional surgical techniques, including suture, ligature and cautery, is ineffective or impractical. TISSEEL is not indicated for the treatment of massive and brisk arterial or venous bleeding. TISSEEL has also been shown to be an effective sealant as an adjunct in the closure of colostomies and is a satisfactory hemostatic agent in fully heparinized patients undergoing cardiopulmonary bypass. TISSEEL is contraindicated in individuals who are known to be hypersensitive to bovine protein. Do not inject TISSEEL directly into blood vessels. Intravascular application or injection of TISSEEL directly into tissues may result in life-threatening, thromboembolic events and/or allergic/anaphylactoid reactions. Especially in coronary bypass surgery, TISSEEL should be applied with caution to minimize any risk of inadvertent intravascular application. The safety and effectiveness of TISSEEL used alone or in combination with bio-compatible carriers in neurosurgical procedures or other surgeries involving confined spaces have not been evaluated.

As with all human plasma-derived therapeutics, the potential to transmit infectious agents, such as viruses, cannot be totally eliminated.

Contact

Mr. Raj Kumar : 98422 – 84678, 99522 – 88889

FLOSEAL is a trademark of Baxter International Inc.

For More Information

External Site : www.baxterbiosurgery.com

CUTSEAL

About CUTSEAL TM [N-Butyl-2-cyanoacrylate 0.15 ml & 0.25 ml ampoule]

CUTSEAL is indicated for a major medical advance in the treatment of wounds and incisions. CUTSEAL is one of the time – tested tissue adhesive.

  • For the closure of uncomplicated skin lacerations
  • As a painless alternative to suturing for wound repair
  • In various surgeries, emergency rooms, trauma units
  • In firstaid situations where wound closure is necessary and sutures are not warranted
  • Cutseal is the tissue adhesive par excellence.

Cutseal is a Novel Tissue Adhesive. Fast action Polymerizes within 10 seconds. Average time for wound closure 60 seconds.

Cutseal Benefits

  • Incisions closure 3 times faster than regular stitches, strong flexible bond
  • No need for Bandages
  • Complete skin healing within 5-10 days
  • No removal of stitches a traumatic
  • Excellent cosmetic results compared to stitches
  • Effective antibacterial protection
  • Significant reduction in precious O. T. Time
  • Hold upward Cutseal ampoule and cut about 4 mm from the tip.

Indications

  • General Surgery
  • Plastic Surgery
  • Gastrointestinal Surgery
  • Urogenital Surgery
  • ENT Surgery
  • Paediatric Surgery
  • Orthopedic Surgery
  • Opthalmic Surgery
  • Surgical procedures in Obstetrics and Gynaecology

Contraindications

Contaminated wounds, Vascular Surgery, Application on Brain and Neuronal Surfaces

Precautions

  • Each Cutseal ampoule is for single use only.
  • Cutseal must be used in its liquid form only.
  • Viscous state of Cutseal should be discarded.
  • Do not place a continuous layer of Cutseal between two healing surfaces because Cutseal breaks down slowly thus hindering the healing process.
  • Cutseal should not be used below the skin because polymerized material is not absorbed by tissue and can elicit a foreign body reaction.
  • Avoid contact of Cutseal with surgical instruments, gloves or fingers during application.
  • Cutseal can be removed by applying acetone or dimethyl formaldehyde in case of accidental adhesion.

Storage

Store between 5 °C to 25 °C Protect from light and moisture.

Application

  • Applied only to outside surfaces to bridge over edges.
  • Do not apply directly to raw surfaces
  • The wound edges should be straight and lie together naturally
  • Insert a tampon, clean the wound thoroughly and dry the skin adequately
  • Stabilize the wound edges from top to bottom
  • Insert the finger between the edges and pull it out to bring them forward slightly. This is to ensure the wound edges are not rolled inward, but meet perfectly.
  • Two surfaces of wound to be held in place with a tissue forcep.
  • Tear out the blister of ampoule.
  • Hold upward Cutseal ampoule and cut about 4 mm from the tip.
  • During application do not touch tissues with the ampoule.
  • Apply a bead of tiny droplets of Cutseal adhesive at intervals where the wound edges meet.
  • Wait for 20 to 30 seconds to dry the area. Cutseal adhesive will stiffen when dry.
  • 0.25ml / 0.15ml of Cutseal would be sufficient to make the closure of about 25cm /15cm of wound respectively.
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