Ethicon Receives FDA 510(k) Clearance for VISTASEAL Open and Laparoscopic Dual Applicator Devices

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 provider 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 percent to 68 percent of cases in open surgery procedures experience disruptive bleeding events.³
 
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.
 
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. Through Ethicon’s surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and its commitment to treat serious medical conditions like obesity and cancer worldwide, the company delivers innovation to make a life-changing impact.
 
As the world’s most comprehensive medical devices business, Johnson & Johnson Medical Devices Companies is 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 the organization is working to profoundly change the way care is delivered.  
 
* 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.
 
References
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.