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.
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.
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.
* 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. Vistasealiseffective in heparinized patients. For complete information including indications, contraindications, warnings, precautions, adverse reactions, and directions for use, consult the product package insert.
 Parekh AK, Barton MB. The challenge of multiple comorbidity for the US health care system. JAMA. 2010;303(13): 1303-1304.
 MedMarket Diligence (2012) Worldwide surgical sealants, glues, wound closure, and anti-adhesion markets, 2010-2017. Report #S190.
 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.