Z-Medica QuikClot Interventional Hemostatic Bandages Now Available for Use During Catheterization Procedures

SAN FRANCISCO--(BUSINESS WIRE)--Z-Medica Corporation, a medical device company developing innovative hemostatic agents, today announced the availability of the QuikClot® Interventional™ hemostatic bandage, on display at booth #1338 at the 21st annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium, sponsored by the Cardiovascular Research Foundation. One of the primary applications for the new QuikClot® Interventional™ hemostatic bandage is to control arterial and venous bleeding following cardiac catheterization or other vascular access procedures that traditionally have required considerable manual compression time or clamping which can be painful for the patient.
QuikClot® Interventional™ is a non-invasive, easy to use hemostatic bandage indicated for use in the local management and control of external bleeding from vascular access sites and percutaneous catheters or tubes utilizing sheaths of up to 12 Fr. It is safe to use and proven effective for use on femoral and other arterial and venous bleeds. It contains an inert and inorganic mineral that has no known contraindications and accelerates the body’s natural hemostatic process. For ease of use, the product does not require any advance preparation and is double-packaged in a blister package and a foil pouch for aseptic technique. It includes a 3M® Tegaderm® adhesive bandage for easy application.
QuikClot® Interventional™ is applied in three simple steps and requires no special training. The health care professional removes the hemostatic pad from the packaging and places it into the sterile field using sterile technique. The hemostatic pad is then placed on the puncture site and manual pressure is applied for at least five minutes or until bleeding stops. Finally, without moving or lifting the pad, the 3M® Tegaderm® adhesive bandage is applied over the pad and secured to the skin, while manual compression is maintained. The QuikClot® hemostatic pad may be left in place for up to 24 hours and can be removed by gently peeling away the Tegaderm® bandage and removing the pad. QuikClot® Interventional™ is currently being used in several interventional cardiology and radiology laboratories across the U.S. Recently, Z-Medica Corporation has gathered over 300 documented reports of human use of this product with an overall success rate of 98.2%, meaning that this novel device was able to achieve hemostasis in virtually all cases following arterial and venous catheterization.

CryoLife (CRY) And Medafor In Fight Over Hemostase

CryoLife, Inc. and Medafor, Inc. are parties to an exclusive distribution agreement whereby CryoLife distributes Hemostase, an absorbable blood clotting agent manufactured and developed by Medafor.

On September 18, 2009, Medafor informed CryoLife of its belief that CryoLife has materially breached its duties and obligations under the Agreement and gave CryoLife notice of its intent to terminate the Agreement if the breach is not cured within 30 days. While Medafor contends that a material breach has occurred because CryoLife has pursued regulatory approval to distribute Hemostase in Hong Kong, CryoLife believes a court would find that a material breach of the Agreement has not occurred, and that, in the event a breach has occurred, that CryoLife would be able to cure it within 30 days of CryoLife’s receipt of notice. As such, CryoLife does not believe the Agreement will terminate on October 18, 2009.
The Agreement has a three-year term from its effective date of May 1, 2008 and will automatically renew for an additional three-year period if

CryoLife makes minimum purchases as designated under the Agreement; however,

there is no contractual obligation for CryoLife to make minimum purchases. Per the terms of the Agreement, CryoLife is the exclusive distributor of Hemostase in the U.S. for cardiac and vascular surgery (excluding Department of Defense hospitals) and the exclusive distributor internationally (excluding China and Japan) for cardiac, vascular, and general surgery, other than orthopaedic and ear, nose and throat surgery.

As previously discussed in the Company’s Forms 10-Q for the quarters ended March 31, 2009 and June 30, 2009, CryoLife has filed a lawsuit against Medafor alleging that Medafor has violated the Agreement by, among other things, entering into exclusive distribution agreements with other companies with respect to distribution territories reserved for CryoLife per the terms of the Agreement.

Legally embroiled Medafor's issue with SMI (manufacturer of PerClot) was recently dismissed pending review, the court commenting "As a result, the court dismissed Medafor's trade secret claims ...."

Lifebond - Israel has developed a new surgical sealant

Lifebond out of Caesarea Industrial Park, Israel has developed a new surgical sealant which is apparently stronger than the currently used blood-derived fibrin glues. The LifeSeal SLR staple line reinforcement sealant and LifeSeal Surgery sealant for general surgery are two main products from the company that are based on its proprietary hydrogel matrix technology, in which individual protein molecules tend to cross-link and form fibrin-like networks. The company plans to ask for US and European approval to market the material next year.

LifeBond's technology functions through the rapid and biocompatible in situ cross-linking of structural proteins. As they cross-link, proteins in the physiological environment undergo a process of gelation to form an adhesive hydrogel matrix. The properties of the cross-linking reaction and the hydrogel matrix can be controlled to fit a variety of applications.

LifeSeal GI is comprised of LifeBond sealant provided in a specialized two-component applicator syringe. The mixed sealant is applied to anastomosis staple-line junctures in the GI tract to fortify the attachment and prevent leakage until full function is restored. The applicator thoroughly mixes the two components as they are applied and evenly dispenses the sealant onto the staple-line juncture. The sealant can be applied manually or as a gas-assisted spray.

Application of LifeSeal GI onto the staple line moderates tension on the staple line because it stabilizes the tissue sections in relation to each other and adds adhesive strength to the junction. Furthermore, LifeSeal GI seals off the staple holes and narrows the spaces in between each staple. Thus, leakage, bleeding, and tearing at the staple line can be reduced, especially in diseased and fragile tissue.

LifeSeal Surgical sealant is provided in a variety of specialized two-component applicators. The mixed sealant is applied to a wound site or staple-line juncture to prevent fluid or blood leakage until full physiological function is restored. The applicator thoroughly mixes the two components as they are applied and evenly dispenses the sealant onto the wound site or staple-line juncture. The sealant can be applied manually or as a gas-assisted spray. The precise application method can be altered to optimize sealant use for specific applications.

St. Jude Medical to Showcase Complete Cardiovascular Access, Intervention and Hemostasis Management Solutions at Transcatheter Cardiovascular Therapeu

ST. PAUL, Minn.--(Business Wire)-- St. Jude Medical, Inc. (NYSE:STJ) today announced it will display products and technologies from the company`s portfolio of solutions for cardiovascular healthcare professionals at the 21st annual Transcatheter Cardiovascular Therapeutics meeting in San Francisco. The featured products reflect the company`s continued commitment to developing comprehensive, high-performance solutions which advance the practice of interventional cardiology by improving efficiencies and giving physicians more control. The company`s latest products and technologies for access, intervention, hemostasis management, cardiac rhythm management, and valve replacement will be demonstrated and on display on Sept. 23 and Sept. 24 from 9 a.m. to 5 p.m. and Sept. 25 from 9 a.m. to 2 p.m. at the St. Jude Medical booth (#1704) including:

Hemostasis Management:

From active vascular closure to compression-assist devices, St. Jude Medical has the most complete portfolio of products to aid physicians in achieving hemostasis following cardiovascular interventions. St. Jude Medical presents the eighth generation of the successful Angio-Seal product family with the most advanced design yet - the Angio-Seal Evolution. With the addition of two compression-assist devices following the acquisition of Radi Medical Systems, RadiStop Compression-Assist Device and FemoStop Gold Compression-Assist Device, the company can now offer physicians a full spectrum of closure technology to aid hemostasis. * Angio-Seal Evolution Vascular Closure Device: The new Angio-Seal Evolution device incorporates its repeatedly proven active closure system using a fully bioabsorbable anchor with a new, simpler system for deployment. This next-generation product from the industry-leading Angio-Seal product line was designed to reduce the number of necessary steps for closure and to assist physicians in overcoming procedural variables. The need to manually compact the collagen was eliminated, and only one suture cut is required. The Angio-Seal Evolution has received FDA and CE Mark approval. * Other Products on Display: Angio-Seal VIP, RadiStop Compression-Assist Device and FemoStop Gold Compression-Assist Device.

Irish Medical Tech Breakthrough

An Irish medical technology firm has developed a breakthrough device that will propel the company to tap into a US$1bn market. Its first product will launch in the European market in the first half of 2010.
Dublin-based Vasorum Ltd, which specialises in the interventional cardiology and radiology markets, will present the initial results of its First-in-Man clinical study for its flagship device AstraPlug at the world-renowned TCT (Transcatheter Cardiovascular Therapeutics) in San Francisco today.
The AstraPlug system delivers a miniature medical grade biocompatible stainless steel implant which allows immediate control of blood flow on removing a catheter from the groin following minimally invasive procedures such as angiogram, angioplasty or stent placement.
European market launch for AstraPlug is anticipated in the first half of 2010.
About 10 million patients undergo cardiac and peripheral catheterisation procedures annually. This involves the temporary insertion of the catheter into an artery through a vascular puncture.
While a variety of legacy methods cause significant discomfort and require several hours of bed rest, AstraPlug was able to achieve an excellent average time to haemostasis (30 seconds) in a painless manner in the trial group.
“Results from this First-in-Man study are very encouraging,” explained Dr Niall Mulvihill, Department of Cardiology, St James's Hospital, Dublin.
“AstraPlug achieved excellent results even in patients on anticoagulation and suffering from peripheral vascular disease. The rapid haemostasis, minimal training requirement, lack of necessity to exchange the procedure sheath and excellent patient comfort are clear advantages of using the AstraPlug device,” said Mulvihill.
CEO Dr James Coleman, R&D director Christopher Cummins and Dr Robert Perryman, CEO of AltaScience Limited, founded Vasorum Ltd in October 2005.
The trial included the AstraPlugTM device in both 5F and 6F sizes and comprised both diagnostic and interventional cases. The study has been carried out at St. James's Hospital Dublin, by Mulvihill, Dr Peter Crean, chief Dr med Eberhard Grube and colleagues at the Helios Heart Centre in Siegburg, Germany.
“Vasorum has endeavoured to develop the ideal percutaneous arterial puncture closure device,” explained Coleman.
“We believe that this innovative technology will impact very positively on the clinical management of patients undergoing percutaneous interventional vascular procedures.”
“With the market estimated to hit US$1 billion by 2010, the health-care industry in both the US and Europe is crying out for a device such as AstraPlug which will address both hospital’s need for cost effectiveness and patient needs for a speedy recovery,” Dr Coleman added.

Hemostasis, Control of Bloodloss - War, EMS, Military,First Resonders, Ambulance

Cryolife, Bioglue - Chronic Inflammation and Foreign-Body Reaction

Vascular Solutions and Orthovita to present at UBS Global Life Sciences Conference

MINNEAPOLIS, Sept. 15, 2009 (GLOBE NEWSWIRE) -- Vascular Solutions, Inc. (Nasdaq:VASC) today announced that the Company is scheduled to present at the 2009 UBS Global Life Sciences Conference in New York City on Tuesday, September 22, 2009 at 8:00am (EDT). Howard Root, Chief Executive Officer of Vascular Solutions, will deliver the Company's presentation. To hear the live audio webcast and view the slides of the Vascular Solutions' presentation, go to the investor relations page of the Company's web site http://www.vascularsolutions.com and click on the "IR Conferences" icon a few minutes prior to start time to download any necessary software.

MALVERN, Pa.--(Business Wire)-- Orthovita, Inc. (NASDAQ:VITA), an orthobiologics and biosurgery company, announced today that it will present at the UBS Global Life Sciences Conference in New York City. Antony Koblish, chief executive officer of Orthovita, is scheduled to present on Monday, September 21st, at 1:00 p.m. Eastern Time, at the Grand Hyatt New York, 109 East 42nd Street at Grand Central Terminal, New York, New York. A live webcast of the presentation will be available, and can be accessed for 90 days following the conference, by visiting http://cc.talkpoint.com/ubsx001/092109a_ke/?entity=67_MRUUVNQ.

Thrombin in Children

Please find below another reader supplied paper. Thanks to contributor's for assisting further understanding for our community. If you have further articles you consider valuable inclusions for our Clinical Papers Section of the blog please forward to me for review. Of course you can post your own thoughts directly in the forum, available for direct communication with other users.

Thanks HG

Haemacure presentation

MONTREAL, Sept. 14 /PRNewswire-FirstCall/ - Haemacure Corporation (TSX : HAE) reported today on current activities and released the financial results of its third quarter endedJuly 31.
Current Activities
Haemacure and Angiotech Pharmaceuticals, Inc. started work pursuant to the strategic collaboration entered into inJune 2009, including the shipment of product to Angiotech. This collaboration provides Angiotech with license, distribution and supply rights for Haemacure's all-human fibrin sealant and thrombin products, both of which are in development.
Haemacure is actively preparing for the pivotal phase II/III clinical trials for its fibrin sealant and is seeking additional financing.
"We are very pleased with the strategic collaboration Haemacure entered into with Angiotech, which provides liquidity and an important validation of our company and its product candidates." said Joseph Galli, Chairman and Chief Executive Officer of Haemacure. "In addition, we are in discussion with other parties who need fibrin sealant and thrombin to enable their products." concluded Mr. Galli.
Financial Position
Cash, cash equivalents and investments amounted to$336,598 as at July 31, 2009, as compared to $4.6 million as at October 31, 2008. Haemacure estimates that it has cash, and access to liquidity as a result of the transaction with Angiotech, to enable it to operate until the end of calendar year 2009.
Results
Revenues amounted to $15,390, as compared to $25,593 for the same quarter last year. Revenues were exclusively derived from the sale of legacy fibrin sealant application devices. Operating expenses amounted to $824,634, down from $2 million for the same quarter last year. The decrease was mainly attributable to foreign exchange fluctuation and the major cost cutting measures implemented in February 2009 to preserve cash. The consolidated net loss for the quarter amounted to $798,852, or nil per share, as compared to $2 million, or $0.01 per share, for the same quarter last year.