Integra LifeSciences to Acquire DuraSeal(TM) Product Lines From Covidien

PLAINSBORO, N.J., Oct. 28, 2013 (GLOBE NEWSWIRE) -- Integra LifeSciences Holdings Corporation (Nasdaq:IART) announced today it has entered into a definitive agreement with Covidien to acquire the Confluent Surgical product lines, including surgical sealants, adhesion barrier, and, most importantly, DuraSeal(TM). The companies expect to complete this transaction by the end of the first calendar quarter of 2014, subject to receipt of regulatory approvals.
Under the terms of the agreement, Covidien will receive an initial cash payment of $235 million from Integra upon the closing of the transaction. Additionally, Covidien may receive up to $30 million, contingent upon the achievement of certain performance measures related to the transition of the Confluent Surgical business to Integra.
"The addition of the DuraSeal(TM) product lines enables our sales force and distributor partners to provide their customers with a best-in-class dural sealant as they seek to support surgeon's efforts to minimize cerebrospinal fluid leaks upon completion of the surgical procedure," said Robert Davis, President of Integra's U.S. Neurosurgery division. "This acquisition perfectly complements our global Neurosurgery growth strategy aimed at providing a broader set of solutions for surgical procedures in the head. Together with our broad DuraGen(R) product line we are fortunate to have even more options to serve our customers and the individual needs of their patients."
"This transaction allows Covidien to better focus on its global strategic priorities," said Bryan Hanson, Group President, Medical Devices & U.S., Covidien. "Based on Integra's presence in neurosurgery and spine surgery combined with a strong portfolio of clinical evidence, we believe these products will thrive under Integra's ownership. We express our sincere gratitude to our dedicated employees and the clinicians who have partnered with us throughout the years."
Confluent Surgical products include: DuraSeal(TM), DuraSeal(TM) Exact/Xact, VascuSeal(TM) and SprayShield(TM). These products generated approximately $65 million in revenue (unaudited) during 2012 and gross margin comparable to Integra's regenerative medicine product portfolio. Integra expects to provide detailed guidance regarding the financial impacts of this transaction upon closing. Preliminarily, Integra would expect the acquisition to add $57 million to $60 million in revenue in the first full year of the combination, and to then grow 3% to 5% longer term.
"This transaction adds scale to our business, leverages one of our strongest customer call points, and drives accretion to our gross margins," said Jack Henneman, Integra's Chief Financial Officer. "Upon completion of the transaction, we expect this deal to be accretive to both GAAP and adjusted earnings per share in the first year after considering the financing costs of the transaction."
Integra expects that revenues acquired through this transaction would be reported in its U.S. Neurosurgery and International divisions.

DuraSeal™ Sealants vs. Tisseel™ Fibrin Sealant

In-vitro hemostasis test platform

An interesting new idea from Covidien could relieve the need for animal testing, while the pig and rats are used in most western countries, in China the animal of choice are dogs and rabbits. Regardless it is an interesting concept with other potential applications.

This paper appears in: Bioengineering Conference (NEBEC), 2011 IEEE 37th Annual Northeast 
Issue Date: 1-3 April 2011 
On page(s): 1 - 2 
Location: Troy, NY, USA 
ISSN: 2160-7001 
Print ISBN: 978-1-61284-827-3 
Digital Object Identifier: 10.1109/NEBC.2011.5778553  
Date of Current Version: 27 May 2011 

ABSTRACT

To avoid unnecessary preclinical testing of Covidien's hemostatic agent patch product, a test platform is needed to test the “time-to-hemostasis” of blood using the patch. The test platform needs to utilize in vitro testing, providing an alternative to in vivo testing. Understanding how “time-to-hemostasis” is affected by Covidien's various products will help surgeons prevent unnecessary bleeding when performing surgery, aid doctors healing large wounds from military events or other accidents, and will be useful in many other ways to prevent bleeding out that could fatally harm the patient. In order to stop the use of animal testing for this product, Covidien would like to have a bench-top in vitro testing device for their products. This device must be able to accurately simulate blood flow through a wound site, as well as simulate the hemostasis process of closing the wound through blood clotting. Important features of the finished device include accurate simulation of blood flow through a wounded tissue, accurately measure the time-to-hemostasis, and the ability to test multiple types of hemostat products efficiently. The device will provide Covidien with an in-house alternative to in vivo testing, saving time and expenditure when testing hemostats.

Covidien Introduces First FDA-Approved Spine Sealant

NORTH HAVEN, Conn.--(BUSINESS WIRE)-- Covidien (NYSE: COV), a leading global provider of healthcare products, today announced the launch of DuraSeal(TM) spine sealant, the first product approved by the U.S. Food and Drug Administration (FDA) for intra-operative sealing of the dural membrane during spine procedures. Nearly 1.5 million spine surgeries are performed in the U.S. every year, with an estimated 10% of these surgeries requiring dural repair and sealing. Tears in the dura the outermost membrane covering the brain and the spinal cord can result in cerebral spinal fluid (CSF) leaks after surgery, leading to possible medical complications and extended hospital stays. One recent study found that CSF leaks after spinal surgery are estimated to cost an average of $6,479 in additional expense, mainly due to longer hospital and intensive care unit stays.(1)
In a clinical study of more than 150 patients, DuraSeal spine sealant was shown to be superior at achieving an intra-operative watertight seal, compared with the control group, which consisted of conventional methods of dural closure such as sutures or fibrin sealants. DuraSeal spine sealant achieved an intra-operative watertight seal 100% of the time, compared with 64% of the time by the control group. The safety results between the two groups were similar, given the patients' medical conditions and the nature of the complex spinal procedures performed.(2)
The new sealant is a 100% synthetic hydrogel that provides excellent tissue adherence, is absorbed by the body and is easy to apply. Stored at room temperature, DuraSeal spine sealant takes only two minutes to prepare and three seconds to set, which enables surgeons to achieve an intra-operative dural seal quickly.
"DuraSeal is a great example of how we develop solutions at Covidien," said Dr. Michael Tarnoff, Chief Medical Affairs Officer, Surgical Devices, Covidien. "We observe the challenges that surgeons face in the operating room and work with the medical community to come up with innovative products that may optimize patient outcomes, can improve healthcare economics and are intuitive for surgeons and their teams to use."
The DuraSeal spine sealant system was introduced today at the North American Spine SocietyAnnual Meeting in San Francisco and last month at the Congress of Neurological Surgeons in New Orleans. For further information, please visit www.durasealspine.com.
ABOUT COVIDIEN
Covidien is a leading global healthcare products company that creates innovative medical solutions for better patient outcomes and delivers value through clinical leadership and excellence.Covidien manufactures, distributes and services a diverse range of industry-leading product lines in three segments: Medical Devices, Pharmaceuticals and Medical Supplies. With 2008 revenue of$10 billion, Covidien has more than 41,000 employees worldwide in 59 countries, and its products are sold in over 140 countries. Please visit www.covidien.com to learn more about our business.

DuraSeal Spine Sealant Receives FDA Approval

WALTHAM, Mass.--(Business Wire)--
Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that the U.S. Food and Drug Administration (FDA) has approved DuraSeal spine sealant for use in the United States. This is the first product that has been approved specifically as an adjunct to suturing for intra-operative dural sealing in spine procedures.
DuraSeal spine sealant has been shown in a U.S. pivotal study to deliver an intra-operative watertight seal 100% of the time1. In the same study, commonly used sealing methods achieved an intra-operative watertight seal only 64% of the
time. The remaining patients were treated with additional products and/or techniques to achieve a watertight seal.
"DuraSeal continues Covidien`s dedication to scientific, evidence-based innovation that improves patient outcomes," said Dr. Michael Tarnoff, Chief Medical Affairs Officer, Surgical Devices, Covidien.
"There`s a critical need to resolve cerebrospinal fluid leaks within the OR. We cannot continue with the procedure until we`ve dealt with the leak," said Dr. Neill Wright, Associate Professor, Neurological & Orthopedic Surgery, Washington University School of Medicine.
The DuraSeal spine sealant is designed to be a quicker solution than conventional sealing methods, for surgeons who are faced with a dural tear:
* The fast-acting, self-contained sealant gives surgeons the only FDA-approved, easy-to-use solution for sutured dural tears, which occur in nearly 10% of all spinal surgeries.
* The DuraSeal spinal sealant only takes two minutes to prepare for use and three seconds to set, so surgeons can quickly complete an intra-operative dural seal.
* The same formulation was approved by the FDA in 2005 and is currently on the market for cranial procedures. Since its approval, more than 210,000 units have been sold worldwide. DuraSeal Cranial and DuraSeal Xact ABS (spine) are also available in Europe and other international markets.
Covidien expects to launch DuraSeal spine sealant in the next few weeks.

VNUS Medical Technologies purchased for $400 million

Covidien Ltd said on Friday it would acquire VNUS Medical Technologies for $400 million in cash to expand its vascular business.
San Jose, Calif.-based VNUS makes products that treat varicose veins and venous reflux disease, a circulatory condition that causes blood to pool in the veins of the leg. The condition can cause swollen veins and discolored skin.
Covidien, based in Dublin, Ireland, manufactures, distributes and services a diverse range of product lines in four segments: Medical Devices, Imaging Solutions, Pharmaceutical Products and Medical Supplies.
VNUS's products include the VNUS Closure system, which employs a disposable radiofrequency catheter that controllably heats and closes diseased veins.
In a randomized clinical trial, the system was proven to be as effective as vein stripping, an open surgical procedure that has been the historical standard for treatment for venous reflux disease, but with fewer side effects and faster recovery, the company said. Commenting on the merger, Joe Almeida, president, Medical Devices for Covidien, said, "The VNUS product line will be an important addition to our innovative portfolio of vascular intervention products."

Covidien Introduces the SprayShield TM Adhesion Barrier System to the European Marketplace

Covidien (NYSE: COV, BSX: COV), a leading global provider of healthcare products, today announced that its Surgical Devices business unit has introduced the SprayShield TM Adhesion Barrier System throughout Europe. The SprayShield Adhesion Barrier System offers surgeons a unique synthetic, sprayable hydrogel that provides a strong barrier between tissue and organ planes that helps reduce the development of post–surgical adhesions. The SprayShield Adhesion Barrier System, which has received CE–Mark, is indicated for use in both open and laparoscopic abdominopelvic surgical procedures as an adjunct to good surgical technique.
"The SprayShield Adhesion Barrier System represents yet another innovative solution delivered by our BioSurgery team," said Scott Flora, President, Surgical Devices, Covidien. "Like our other recent product introductions, including PleuraSeal TM lung sealant and VascuSeal TM vascular sealant, the SprayShield Adhesion Barrier System gives surgeons a new solution to help address an unmet clinical need," he added.
Adhesions frequently occur after surgery due to tissue trauma that forms connective tissue bridges, or internal bands in the body, that can connect internal structures and organs that normally are separated. Adhesions have been associated with post–operative complications such as pelvic pain, infertility and small bowel obstruction that may require additional surgery to resolve. A long–term comprehensive study of women who had prior pelvic surgery showed that approximately 35% were readmitted an average of 1.9 times over a 10–year period due to adhesion–related complications. Even during routine surgical procedures, the need to remove adhesions extends operating room time and can lead to increased blood loss and other complications.
The SprayShield Barrier technology is a synthetic, absorbable hydrogel delivered by an air–assisted sprayer. The device can be stored at room temperature and prepared in less than two minutes. The SprayShield Adhesion Barrier polymerizes within seconds when sprayed, enabling site–specific application, and is blue in color, allowing the surgeon to see the coverage and thickness of the material upon application. Post–operatively, the SprayShield Barrier continues to separate tissue and organ planes as healing progresses under the gel. After several days, the hydrogel breaks down into water–soluble molecules that are absorbed and cleared through the kidneys.
In addition to Europe, the SprayShield Adhesion Barrier System is available in certain Middle East markets and South Africa. It is not available in the United States at this time.

Vascular Closure - Hemostasis of the femoral artery

Every year, millions of people worldwide undergo a femoral artery catheterization. The early discharge of these patients undergoing elective diagnostic and interventional procedures, such as angiography, percutaneous transluminal coronary angioplasty (PTCA), stenting, atherectomy, and catheter ablation, hinges on the lack of bleeding complications at the access site after the procedure sheath is removed from the femoral artery. The size of the access route, coupled with routine administration of anticoagulants, creates a strong need to stop bleeding at the puncture site as quickly as possible. However, hemostasis must be achieved without producing clotting in the vessels just treated in order to prevent a potentially fatal myocardial infarction or thrombosis. Simple compression – the use of hand pressure, clamps, and/or sandbags – is currently the standard of care for managing femoral vascular access sites following interventional cases. Under this conventional technique, anticoagulation therapy is discontinued for up to four hours prior to vascular closure in order to permit the patient’s clotting capability to return to a normal state.Throughout this period, the introducer sheath remains in place and the patient must remain immobilized to prevent bleeding. Upon sheath removal, direct compression is applied to prevent bleeding and formation of hematomas. While the patient lies flat, a nurse or technician holds direct manual pressure on the site for 20 to 60 minutes until thrombus forms to seal the access site. This monotonous and tiresome task often relies on trained hospital personnel to administer. Use of sandbags and other adjunctive mechanical compression devices like C-clamps may reduce the need for the nurse or other skilled individual to continuously hold initial manual pressure.There is the possibility for these compression devices to slip, necessitating close monitoring of the patient during this critical time to ensure correct compression of the access site. Additionally, these devices have failed to show measurable advantages over hand pressure and may increase patient discomfort. Once hemostasis has been achieved, the patient’s leg must remain motionless for a minimum of six and up to 24 hours (depending on the amount of anticoagulation drug therapy used and the particular procedure) in order to avoid dislodging of the clot, which can lead to internal or external bleeding.

Vascular Closure Products

Morris Innovative - FISH

St.Jude - Angioseal

Medtronic Inc. - EVS vascular stapling system, Clo-Sur PAD

Covidien - VascuSeal

Abbott - Closure S, Perclose A-T, Perclose ProGlide, Prostar, StarClose, Chitoseal

AccessClosure - Mynx

Cardiva - Boomerang

Medafor - MPatch

Sutura - SuperStitch

Vascular Solutions - Duett, Duett Pro, D-Stat

Radi Medical - FemoStop, RadiStop

Covidien Introduces the VascuSeal

Covidien (NYSE: COV, BSX: COV), a leading global provider of healthcare products, today announced that its Surgical Devices business unit has introduced the VascuSeal™ Vascular Sealant System throughout Europe and in select Middle East markets. VascuSeal™ offers surgeons a unique advanced hydrogel that provides an immediate, blood-tight seal that is effective intraoperatively and throughout the critical healing period. VascuSeal™, which is CE-Marked, is intended for use as a surgical sealant during arterial and venous reconstructions to seal suture lines.
Unlike a hemostatic agent, a vascular sealant can seal blood leaks and does not depend on either the time for the blood to clot or the strength of the blood clot to perform successfully. The VascuSeal™ Sealant System offers surgeons a valuable tool to reduce bleeding from the suture line in vascular bypass procedures, and reduces post-operative complications associated with suture line bleeding.
The VascuSeal™ sealant technology is a patented synthetic, absorbable hydrogel delivered by a dual syringe applicator. The device can be stored at room temperature and prepared in less than two minutes. VascuSeal™ sealant polymerizes within seconds when sprayed on the suture line and is blue in color which provides the vascular surgeon visualization of coverage and thickness of the material upon application. Postoperatively, VascuSeal™ sealant continues to seal the suture line as healing progresses under the gel. After several days, the hydrogel breaks down into water-soluble molecules that are absorbed and cleared through the kidneys.
“The VascuSeal™ Vascular Sealant System represents another innovative product in the BioSurgery marketplace,” said Scott Flora, President, Surgical Devices, Covidien. “We expect VascuSeal™ to be well-received by surgeons looking to improve patient outcomes, save time and reduce blood loss during surgical procedures,” added Flora.