Innovative Products

Ethicon offers a broad portfolio of market-leading, innovative devices to meet the changing demands of today’s most challenging gynecologic procedures.

HARMONIC ACE®+7 SHEARS with Advanced Hemostasis

World-class precision with secure and reliable sealing

The first and only purely ultrasonic energy device with a 7mm vessel sealing indication.§ Adaptive Tissue Technology delivers unmatched precision, multifunctionality, and now Advanced Hemostasis for stronger vessel sealing.

Learn more about adaptive tissue technology navigate_next

ENSEAL® G2 Articulating Tissue Sealer

Gentle on tissue. Strong on sealing.

Facilitates a perpendicular approach to vessels and provides access to tissue in deep or tight spaces* and the ability to maneuver around corners and behind structures.

Explore with versatility navigate_next

SURGICEL® Family of Absorbable Hemostats

Focus on the procedure, not the bleed.

SURGICEL® Family of Absorbable Hemostats is the first and only absorbable hemostat that is proven bactericidal in vitro against a broad range of gram-positive and gram-negative organisms including various antibiotic resistant bacteria (MRSA, VRE, PRSP and MRSE)250,†

Proven bactericidal advantage navigate_next

STRATAFIX™ Knotless Tissue Control Devices

Delivering more consistency, more security, and more efficiency.

With more points of fixation than traditional sutures, STRATAFIX™ Devices provide more consistent tension control over every pass and provides more security and strength than interrupted suture closure with more efficiency than continuous closure.141,145,150

The security of interrupted suturing navigate_next

RELATED PROCEDURAL PRODUCTS


 

SURGICEL Essential Product Information

INDICATIONS

SURGICEL® Absorbable Hemostat (oxidized regenerated cellulose) is used adjunctively in surgical procedures to assist in the control of capillary, venous, and small arterial hemorrhage when ligation or other conventional methods of control are impractical or ineffective. SURGICEL® ORIGINAL, SURGICEL® FIBRILLAR™ and SURGICEL® NU-KNIT® Hemostats can be cut to size for use in endoscopic procedures.

PRECAUTIONS

Use only as much SURGICEL® Absorbable Hemostat as is necessary for hemostasis, holding it firmly in place until bleeding stops. Remove any excess before surgical closure in order to facilitate absorption and minimize the possibility of foreign body reaction

In urological procedures, minimal amounts of SURGICEL® Absorbable Hemostat should be used and care must be exercised to prevent plugging of the urethra, ureter, or a catheter by dislodged portions of the product.

Since absorption of SURGICEL® Absorbable Hemostat could be prevented in chemically cauterized areas, its use should not be preceded by application of silver nitrate or any other escharotic chemicals.

If SURGICEL® Absorbable Hemostat is used temporarily to line the cavity of large open wounds, it should be placed so as not to overlap the skin edges. It should also be removed from open wounds by forceps or by irrigation with sterile water or saline solution after bleeding has stopped.

Precautions should be taken in otorhinolaryngologic surgery to assure that none of the material is aspirated by the patient. (Examples: controlling hemorrhage after tonsillectomy and controlling epistaxis.)

Care should be taken not to apply SURGICEL® Absorbable Hemostat too tightly when it is used as a wrap during vascular surgery (see Adverse Reactions).

ADVERSE EVENTS

“Encapsulation” of fluid and foreign body reactions have been reported.

There have been reports of stenotic effect when SURGICEL® Absorbable Hemostat has been applied as a wrap during vascular surgery.

Paralysis and nerve damage have been reported when SURGICEL® Absorbable Hemostat was used around, in, or in proximity to foramina in bone, areas of bony confine, the spinal cord, and/or the optic nerve and chiasm.

Blindness has been reported in connection with surgical repair of a lacerated left frontal lobe when SURGICEL® Absorbable Hemostat was placed in the anterior cranial fossa.

Possible prolongation of drainage in cholecystectomies and difficulty passing urine per urethra after prostatectomy have been reported.

For more information, please consult your doctor or for product quality and technical questions, call 1-800-795-0012.

 

GYNECARE INTERCEED® Essential Product Information

INDICATIONS

GYNECARE INTERCEED® Absorbable Adhesion Barrier is indicated as an adjuvant in open (laparotomy) gynecologic pelvic surgery for reducing the incidence of postoperative pelvic adhesions after meticulous hemostasis is achieved consistent with microsurgical principles.

CONTRAINDICATIONS:

The use of GYNECARE INTERCEED®> (TC7) Absorbable Adhesion Barrier is contraindicated in the presence of frank infection. GYNECARE INTERCEED® is not indicated as a hemostatic agent. Appropriate means of achieving hemostasis must be employed.

WARNINGS:

The safety and effectiveness of GYNECARE INTERCEED® in laparoscopic surgery or any procedures other than open (laparotomy) gynecologic microsurgical procedures have not been established. Postoperative adhesions may be induced by GYNECARE INTERCEED® application if adjacent tissues (eg, ovary and tube) and structures are coapted or conjoined by the device, or if GYNECARE INTERCEED® is folded, wadded or layered. Postoperative adhesions may occur in the presence of GYNECARE INTERCEED® if meticulous hemostasis is not achieved prior to application. As with all foreign substances, GYNECARE INTERCEED® should not be placed in a contaminated surgical site.

PRECAUTIONS

Use only a single layer of GYNECARE INTERCEED®, since multiple layers of packing or folding will not enhance the adhesion barrier characteristics and may interfere with the absorption rate of GYNECARE INTERCEED®. Care should be exercised in applying GYNECARE INTERCEED® to a pelvic organ not to constrict or restrict it. If the product comes in contact with blood prior to completing the procedure, it should be discarded, as fibrin deposition cannot be removed by irrigation and may promote adhesions formation. Ectopic pregnancies have been associated with fertility surgery of the female reproductive tract. No data exist to establish the effect, if any, of GYNECARE INTERCEED® on the occurrence of ectopic pregnancies. No adequate studies have been conducted in women who have become pregnant within the first month after exposure to GYNECARE INTERCEED®. No teratogenic studies have been performed. Therefore, avoidance of conception should be considered during the first complete menstrual cycle after use of GYNECARE INTERCEED®. The safety and effectiveness of using GYNECARE INTERCEED® in combination with other adhesion prevention treatments have not been clinically established. GYNECARE INTERCEED® is supplied sterile. As the material is not compatible with autoclaving or ethylene oxide sterilization, GYNECARE INTERCEED® must not be resterilized. Foreign body reactions may occur in some patients. Interactions may occur between GYNECARE INTERCEED® and some drugs used at the surgical site. Pathologists examining sites of GYNECARE INTERCEED® placement should be made aware of its usage and of the normal cellular response to GYNECARE INTERCEED® ‘to facilitate proper evaluation of specimens'.

ADVERSE EVENTS

The type and frequency of adverse events reported are consistent with events typically seen following surgery. Postsurgical adhesions may occur in the presence of GYNECARE INTERCEED®.

For more information, please consult your doctor or call 1-888-GYNECARE to speak with a nurse

Site References

  • * Compared to a non-articulating device.
  • Based on articulation data from IFUs of each device.
  • § Internal market analysis as of 1/31/2014.
  • In bench-top studies with 5‐7mm porcine carotids that compared median burst pressure, HARMONIC ACE+7 exhibited higher burst pressures vs. LigaSure™ 5mm Blunt Tip (p<0.001) and LigaSure™ Advance (p<0.001).
  • Compared to traditional sutures.
  • Methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE), penicillin-resistant Streptococcus pneumoniae (PRSP), methicillin-resistant Staphylococcus epidermidis (MRSE).
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