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

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Johnson & Johnson Medical Devices Companies that Ethicon has received 510(k) clearance from the U.S. 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.