Ethicon Announces 510(K) Clearances for VISTASEAL Open and Laparoscopic Dual Applicator Devices Designed to Deliver Biologics That Address Surgical Bleeding

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VISTASEAL Dual Applicator is the First Product to Emerge from Recent Strategic Partnership Between Ethicon and Grifols, Leading Maker of Plasma-Derived Medicines
 

SOMERVILLE – Johnson & Johnson Medical Devices Companies* today announced that Ethicon** has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its VISTASEAL open and laparoscopic Dual Applicators (35 cm and 45 cm), three next generation airless spray devices that combine biologics with device technology to address mild to moderate surgical bleeding.  

These biosurgery products are the first to emerge from a recently forged long-term strategic partnership between the global device maker and Grifols, a world leader in the production of plasma-derived medicines. Grifols developed the Vistaseal Fibrin Sealant (Human)***, and Ethicon’s devices are designed to deliver the two biological components of the product.

Beyond VISTASEAL, the partnership with Grifols will provide a supply of thrombin for Ethicon’s current products. In the future, it will mean even more advances in the field of adjunctive hemostats with the goal of reducing complications and improving the standard of care. 

“Ethicon’s biosurgery portfolio offers a broad array of technologies that address intraoperative bleeding, which is among the most difficult challenges facing surgeons and their patients,” said Oray Boston, President, Worldwide Biosurgery, Ethicon. “Our partnership with Grifols will leverage our strengths in device technology with Grifols’ strengths in plasma-derived medicines to expand our portfolio and accelerate innovation in the fast growing field of biosurgery.” 

Bleeding-related complications and perioperative fluid and air leaks adversely affect patient outcomes and increase healthcare costs. Studies show patients suffer from a growing number of comorbidities and other factors that increase the risk of surgical bleeding.1,2  An estimated 32 to 68 percent of cases in open surgery procedures experience disruptive bleeding events.3 

Ethicon is working to standardize the use of adjunctive hemostats and sealants by offering the most appropriate product for each bleeding and leak site and situation. It is the only medical device company that provides a full range of both primary and adjunctive hemostats that address surgical bleeding.

The company’s current biosurgery portfolio includes the SURGICEL Family of Absorbable Hemostats, which is backed by more than 50 years of proven safety and efficacy and includes the latest addition, SURGICEL Powder, which provides efficient control of continuous oozing bleeding on broad surfaces. The portfolio also includes EVICEL Fibrin Sealant, which provides sustained hemostasis, demonstrated in high-risk patients, with effective clot formation regardless of patient coagulation profile and the SURGIFLO Hemostatic Matrix, which provides a matrix for platelet adherence to accelerate the formation of the platelet plug aiding in fibrin clot formation.

About Ethicon
Ethicon, part of Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 100 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com.

About Johnson & Johnson Medical Devices Companies 
As the world’s most comprehensive medical devices business, we are building on a century of experience, leveraging science and technology, to shape the future of health care. With unparalleled breadth, depth and reach in surgery, orthopaedics, vision and interventional solutions we are working to profoundly change the way care is delivered. We are in this for life. 

Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding Ethicon’s Biosurgery Platform. The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Ethicon Endo-Surgery, LLC, any of the other Johnson & Johnson Medical Devices Companies and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: uncertainty of regulatory approvals; uncertainty of commercial success; challenges to patents; competition, including technological advances, new products and patents attained by competitors; manufacturing difficulties and delays; product efficacy or safety concerns resulting in product recalls or regulatory action; changes to applicable laws and regulations, including global health care reforms; changes in behavior and spending patterns of purchasers of health care products and services; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2018, including in the sections captioned “Cautionary Note Regarding Forward-Looking Statements” and “Item 1A. Risk Factors,” and in the company’s most recently filed Quarterly Report on Form 10-Q, and the company’s subsequent filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Neither the Johnson & Johnson Medical Devices Companies nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
 

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* The Johnson & Johnson Medical Devices Companies comprise the surgery, orthopedics, vision and interventional solutions businesses within Johnson & Johnson’s Medical Devices segment. 
** Ethicon represents the products and services of Ethicon, Inc., Ethicon Endo-Surgery, LLC and certain of their affiliates. All other trademarks are the property of their respective owners.
*** Vistaseal Fibrin Sealant (Human) is indicated as an adjunct to hemostasis for mild to moderate bleeding adults undergoing surgery when control of bleed by standard surgical techniques (such as suture, ligature and cautery) is ineffective or impractical. Vistaseal is effective in heparinized patients. For complete information including indications, contraindications, warnings, precautions, adverse reactions, and directions for use, consult the product package insert. 

MEDIA CONTACT        
Ann Leibson/Ethicon 
[email protected]
513-337-8180    
 

  1. Parekh AK, Barton MB. The challenge of multiple comorbidity for the US health care system. JAMA. 2010;303(13): 1303-1304.
  2. MedMarket Diligence (2012) Worldwide surgical sealants, glues, wound closure, and anti-¬adhesion markets, 2010-¬2017. Report #S190.
  3. Corral M, Hollmann S, Ferko N, Broder M, Chang E, Sun G. Health and Economic Consequences of Controlled vs Uncontrolled Surgical Bleeding in Patients Treated with Haemostatic Agents: A Retrospective Analysis of the Premier Perspective Database. SABM, 2014. 

 

VISTASEAL™ Fibrin Sealant (Human) IMPORTANT SAFETY INFORMATION 

INDICATION 

VISTASEAL™ is indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical.  VISTASEAL is effective in heparinized patients. 

 

CONTRAINDICATIONS 

Do not inject directly into the circulatory system.  

Do not use for the treatment of severe or brisk arterial bleeding. 

Do not use in patients with history of anaphylaxis or severe systemic reactions to human blood products. 

Do not use VISTASEAL for spraying unless the minimum recommended distance from the applicator tip to the bleeding site can be achieved.  

 

WARNINGS AND PRECAUTIONS  

Thromboembolic events may occur if VISTASEAL is administered intravascularly.  

Only spray VISTASEAL if it is possible to accurately judge the distance from the spray tip to the tissue surface.  

Hypersensitivity reactions can occur.  

May carry a risk of transmitting infectious agents, e.g., viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and, theoretically, the Creutzfeldt-Jakob disease (CJD) agent.  

 

ADVERSE REACTIONS 

The most common adverse reactions (reported in >1% of clinical trial subjects) were nausea and procedural pain.  

For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.

 


SURGICEL® Powder Absorbable Hemostat Essential Product Information 

INDICATIONS 

SURGICEL® Powder (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® Powder can also be applied in laparoscopic or other endoscopic procedures when used with the SURGICEL™ Endoscopic Applicator. 

The SURGICEL™ Endoscopic Applicator is intended for use in delivering SURGICEL® Powder absorbable hemostat to bleeding surgical sites through a 5 mm or larger trocar. 
 

CONTRAINDICATIONS 

• Do not inject or place SURGICEL® Powder into an open blood vessel. Do not use to treat bleeding from large defects in arteries or veins. 

• SURGICEL® Powder should not be used to control hemorrhage from large arteries or veins. 

• The SURGICEL® Powder and the SURGICEL™ Endoscopic Applicator devices were not designed for intraluminal procedures. 

• When SURGICEL® Powder is used to help achieve hemostasis in, around, or in proximity to foramina in bone, areas of bony confine, the spinal cord, or the optic nerve and chiasm, it must always be removed after hemostasis is achieved since it will swell and could exert unwanted pressure. 

• SURGICEL® Powder should not be used for implantation in bone defects, such as fractures, since there is a possibility of interference with callus formation and a theoretical chance of cyst formation. 

WARNINGS 

•  SURGICEL® Powder is not intended for use on dry (non-bleeding) surfaces or for prevention of bleeding. 

• Closing with SURGICEL® Powder in a contaminated wound without drainage may lead to complications and should be avoided. 

• SURGICEL® Powder should not be impregnated with anti-infective agents or with other materials such as buffering or hemostatic substances.  

• SURGICEL® Powder is dry and there may be difficulties in precise delivery under certain circumstances. Unintentional device placement may result in powder scattering and device migration that may increase the risk of adhesion formation. In preclinical in vivo animal studies it was demonstrated that SURGICEL® Powder does not increase the incidence of remote adhesions in laparoscopic procedures. 

 

• Although SURGICEL® Powder is bactericidal against a wide range of pathogenic microorganisms, it is not intended as a substitute for systemically administered therapeutic or prophylactic antimicrobial agents to control or to prevent postoperative infections. 

•  To prevent clogging with the SURGICEL™ Endoscopic Applicator Tip, do not touch the tip to wet surface. Be careful to avoid damaging tissue with the rigid tip. 

• Do not attempt to trim the applicator tip. Replace the tip if it becomes clogged. 

PRECAUTIONS 

SURGICEL® Powder should not be used in conjunction with autologous blood salvage circuits, because its fragments may pass through the transfusion filters of blood-scavenging systems. 

Use only as much SURGICEL® Powder (oxidized regenerated cellulose) as is necessary and apply only where needed for hemostasis. Remove any excess before surgical closure in order to facilitate absorption and to minimize the possibility of foreign body reaction. 

Use minimal amount of SURGICEL® Powder required to achieve hemostasis, and remove excess powder in the area of drains to prevent clogging.  In urological procedures, minimal amounts of SURGICEL® Powder 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® Powder 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® Powder is used temporarily to line the cavity of open wounds, it should be removed by irrigation with sterile water or saline solution after bleeding has stopped. 

Precautions should be taken in otorhinolaryngologic surgery to ensure that none of the material is aspirated by the patient (e.g., controlling hemorrhage after tonsillectomy and controlling epistaxis). 

The applicator tip provided on the SURGICEL® Powder device is not intended for laparoscopic or other endoscopic use. If laparoscopic or other endoscopic use is desired, remove the existing applicator tip from the SURGICEL® Powder device, and replace with the SURGICEL™ Endoscopic Applicator tip (supplied separately). In laparoscopic or other endoscopic procedures, SURGICEL® Powder should only be applied using the SURGICEL™ Endoscopic Applicator. Consult the SURGICEL™ Endoscopic Applicator Instructions for Use (IFU) for proper assembly and directions for use with the SURGICEL® Powder device. 

The SURGICEL Endoscopic Applicator is supplied with a flexible inner tip inside a rigid cannula. The rigid cannula cannot be used independently. 

The SURGICEL Endoscopic Applicator should only be used by persons having adequate training and familiarity with endoscopic techniques.  Consult medical literature relative to techniques, complications, and hazards prior to performance of any endoscopic procedure.  

To prevent inadvertent device spillage, or unintended contact with tissue, organs, or blood, maintain visualization of the SURGICEL™ Endoscopic Applicator tip at all times. 

Do not compress or excessively bend the flexible inner tip of the SURGICEL Endoscopic Applicator which could obstruct the application of the powder.  It is possible that the powder accumulated in the applicator could disperse beyond the target bleeding site upon compression of the bellows, which may require additional irrigation and aspiration. 

 

ADVERSE EVENTS  

Paralysis and nerve damage have been reported when other SURGICEL® products were 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 other SURGICEL® products were placed in the anterior cranial fossa (see WARNINGS and PRECAUTIONS). 

Foreign body reactions have been reported with other products from the SURGICEL® Family of Absorbable Hemostats. 

Burning has been reported when other SURGICEL® products were applied after nasal polyp removal. Headache, burning, stinging, and sneezing in epistaxis and other rhinological procedures, and stinging when SURGICEL® product was applied on surface wounds (varicose ulcerations, dermabrasions, and donor sites) have also been reported. 

For more information and technical questions, call 1-800-795-0012.  For complete information including indications, contraindications, warnings, precautions, adverse reactions, and directions for use, consult the product package insert.


EVICEL® Fibrin Sealant (Human) IMPORTANT SAFETY INFORMATION 

Indication 

EVICEL® Fibrin Sealant (Human) is indicated as an adjunct to hemostasis for use in patients undergoing surgery, when control of bleeding by standard surgical techniques (such as suture, ligature, or cautery) is ineffective or impractical. 

 

Contraindications 

Do not inject directly into the circulatory system. Intravascular application of EVICEL® may result in life-threatening thromboembolic events. 

Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products. 

Do not use for the treatment of severe or brisk arterial bleeding. 

Do not use EVICEL® for spraying in endoscopic or laparoscopic procedures where the minimum recommended distance from the applicator tip to the target site cannot be ensured. 

 

Warnings and Precautions 

Life-threatening air or gas embolism has occurred with the use of spray devices employing a pressure regulator to administer EVICEL®. This event appears to be related to the use of the spray device at pressures higher than recommended and/or at distances closer than recommended to the surface of the tissue. 

Monitor changes in blood pressure, pulse, oxygen saturation, and end-tidal CO2 when spraying EVICEL® because of the possibility of gas embolism. 

To reduce the risk of potentially life-threatening gas embolism, spray EVICEL® using only pressurized CO2 gas at the pressures and distances recommended for the specific tips. 

Use EVICEL® spray application only if it is possible to accurately judge the spray distance, especially during endoscopic or laparoscopic procedures. 

Prior to applying EVICEL®, dry surface areas of the wound by standard techniques (e.g. intermittent application of compresses, swabs, use of suction devices). Prepare and administer EVICEL® according to the instructions and with only devices recommended for this product. 

May carry a risk of transmitting infectious agents, e.g. viruses, the variant Creutzfeldt-Jakob disease (vCJD) agent and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. 

The most common adverse reactions reported in clinical trials are peripheral edema, abdominal abscess, infection, hematoma, incision site hemorrhage, vascular graft occlusion, postoperative wound complication and decreased hemoglobin. 

For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.


SURGIFLO® Hemostatic Matrix Kit Essential Product Information (Made from Absorbable Gelatin Sponge, USP) with Thrombin

DESCRIPTION

SURGIFLO® with Thrombin (SURGIFLO® Hemostatic Matrix Kit) is intended for hemostatic use by applying to a bleeding surface.

ACTIONS

When used in appropriate amounts SURGIFLO® is absorbed completely within 4 to 6 weeks.

INTENDED USE/INDICATIONS

SURGIFLO®, mixed with thrombin solution, is indicated in surgical procedures (other than ophthalmic) as an adjunct to hemostasis when control of bleeding by ligature or other conventional methods is ineffective or impractical.

CONTRAINDICATIONS

• Do not use SURGIFLO® in intravascular compartments because of the risk of embolization.

• Do not use SURGIFLO® in patients with known allergies to porcine gelatin.

• Do not use SURGIFLO® in closure of skin incisions because it may interfere with the healing of skin edges. This interference is due to mechanical interposition of gelatin and is not secondary to intrinsic interference with wound healing.

WARNINGS

• SURGIFLO® should not be used in the presence of infection and should be used with caution in contaminated areas of the body• SURGIFLO® should not be used in instances of pumping arterial hemorrhage. SURGIFLO® will not act as a tampon or plug in a bleeding site.

• SURGIFLO® should be removed from the site of application when used in, around, or in proximity to foramina in bone, areas of bony confine, the spinal cord, and/or the optic nerve and chiasm because it may swell resulting in nerve damage.

•Excess SURGIFLO® should be removed once hemostasis has been achieved.

• The safety and effectiveness of SURGIFLO® for use in ophthalmic procedures has not been established.

• SURGIFLO® should not be used for controlling post-partum intrauterine bleeding or menorrhagia.

• The safety and effectiveness of SURGIFLO® has not been established in children and pregnant women.

• The blue flexible applicator tip should not be trimmed to avoid exposing internal guidewire.

• The white straight applicator tip should be trimmed away from the surgical area. Cut a square angle to avoid creating a sharp tip.

PRECAUTIONS

• Safe and effective use of SURGIFOAM® Sponge has been reported in a published neurologic retrospective study involving 1700 cases in Europe. Safe and effective use in neurosurgery has not been proven through randomized, controlled clinical studies in the United States.

• SURGIFLO® is supplied as a sterile product and cannot be resterilized. • SURGIFLO® should not be used for packing unless excess product that is not needed to maintain hemostasis is removed. SURGIFLO® may swell up to 20% upon contact with additional fluid.

• SURGIFLO® should not be used in conjunction with autologous blood salvage circuits.

• SURGIFLO® should not be used in conjunction with methylmethacrylate adhesives. • In urological procedures, SURGIFLO® should not be left in the renal pelvis or ureters to eliminate the potential foci for calculus formation.

ADVERSE EVENTS

A total of 142 patients received SURGIFOAM® Sponge during a clinical trial comparing SURGIFOAM® Sponge to another absorbable gelatin sponge. In general, the following adverse events have been reported with the use of absorbable porcine gelatin-based hemostatic agents:

• Gelatin-based hemostatic agents may serve as a nidus for infection and abscess formation and have been reported to potentiate bacterial growth.

• Giant cell granulomas have been observed at implant sites when used in the brain.

• Compression of the brain and spinal cord resulting from the accumulation of sterile fluid have been observed.

• Multiple neurologic events were reported when absorbable gelatin-based hemostatic agents were used in laminectomy operations, including cauda equina syndrome, spinal stenosis, meningitis, arachnoiditis, headaches, paresthesias, pain, bladder and bowel dysfunction, and impotence.

• The use of absorbable gelatin-based hemostatic agents during the repair of dural defects associated with laminectomy and craniotomy operations, has been associated with fever, infection, leg paresthesias, neck and back pain, bladder and bowel incontinence, cauda equina syndrome, neurogenic bladder, impotence, and paresis.

• The use of absorbable gelatin-based hemostatic agents has been associated with paralysis, due to device migration into foramina in the bone around the spinal cord, and blindness, due to device migration in the orbit of the eye, during lobectomy, laminectomy, and repair of a frontal skull fracture and lacerated lobe.

• Foreign body reactions, “encapsulation” of fluid, and hematoma have been observed at implant sites.

• Excessive fibrosis and prolonged fixation of a tendon have been reported when absorbable gelatin-based sponges were used in severed tendon repair.

• Toxic shock syndrome was reported in association with the use of absorbable gelatin-based hemostats in nasal surgery.

• Fever, failure of absorption, and hearing loss have been observed when absorbable hemostatic agents were used during tympanoplasty


EVITHROM® Thrombin, Topical (Human) for Topical Use Only 

Lyophilized Powder for Solution 

EVITHROM® is a topical thrombin indicated as an aid to hemostasis whenever oozing blood and minor bleeding from capillaries and small venules is accessible and control of bleeding by standard surgical techniques (such as suture, ligature or cautery) is ineffective or impractical. 

EVITHROM® may be used in conjunction with an Absorbable Gelatin Sponge, USP. 

Important Safety Information 

For topical use only. 

Do not inject. 

Apply EVITHROM® on the surface of bleeding tissue only. 

The amount of EVITHROM® required depends upon the area of tissue to be treated and the method of application. In clinical studies, volumes up to 10 ml were used in conjunction with Absorbable Gelatin Sponge. 

Do not use for the treatment of severe or brisk arterial bleeding. 

Do not use in individuals known to have anaphylactic or severe systemic reaction to human blood products.  Hypersensitivity reactions, including anaphylaxis, may occur. 

There is a potential risk of thrombosis if absorbed systemically. 

May carry a risk of transmitting infectious agents such as viruses and theoretically, the Creutzfeldt-Jakob disease (CJD) agent, despite manufacturing steps designed to reduce the risk of viral transmission. 

The most common adverse reactions during clinical trial (reported in at least 2% of subjects treated with EVITHROM®) were prolonged activated partial thromboplastin time, increased INR, decreased lymphocyte count, prolonged prothrombin time and increased neutrophil count. 

None of the patients treated with EVITHROM developed antibodies to human thrombin or to human Factor V/Va. The clinical significance of these findings is unknown. 

For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert.