New Tool Calculates Risk Of Bleeding In Heart Attack Patients

Led by Sumeet Subherwal, M.D., formerly a Barnes-Jewish Hospital medical resident at Washington University Medical Center and now a cardiology fellow at Duke University, and in collaboration with several investigators including Karen Alexander, M.D., a cardiologist at the Duke Clinical Research Institute, the researchers analyzed the medical histories of more than 89,000 patients hospitalized in the United States for non-ST-elevation heart attack. This type of heart attack is the most common and usually results from a partial rather than complete blockage of the heart's arteries.
The patient histories were part of the CRUSADE Quality Improvement Initiative, a national multicenter program that aims to improve outcomes for heart attack patients. The risk assessment tool is called the CRUSADE bleeding score.
"A lot of treatment decisions have to be made very promptly after the patient arrives," says Bach, also associate professor of medicine in the Cardiovascular Division at Washington University School of Medicine. "So we designed a bleeding-risk stratification tool that would require only those variables that can be obtained up front. It's a practical tool that can be used in any hospital setting."
The CRUSADE analysis identified eight factors that could predict the odds that a heart attack patient might suffer a bleeding event. The factors are gender, heart rate, blood pressure, hematocrit (the concentration of red cells in the blood), creatinine clearance (a measure of kidney function), diabetes, peripheral vascular disease or stroke, and congestive heart failure.
The bleeding score calculation assigns points to each factor so that the total score coincides with risk of bleeding evidenced in the CRUSADE cases. The range of possible scores is divided into five categories from very low to very high risk of bleeding.
The bleeding risk score is intended to help guide critical early treatment decisions for clinicians caring for heart attack patients, but the impact of its use on outcomes will need to be tested in clinical trials, says Bach. Potentially, the score will be used in conjunction with other practice guidelines to optimize heart attack treatment and minimize risk.

Full article HERE

Surgical Gel Used to Stop Bleeding Could Confuse Mammograms

The Loyola University Health System radiologist saw a suspicious pattern of white specks, much like grains of salt. The specks were calcium deposits similar to microcalcifications that sometimes are a sign of early breast cancer. But it was too early for the patient's breast cancer to have returned because it had been only a month since her lumpectomy. It turns out the microcalcifications were not from cancer. Rather, they were due to a gel that is sometimes used during surgery to stop bleeding. In a recent article in the American Journal of Roentgenology, Ward and colleagues reported seven cases in which the sealant mimicked malignant microcalcifications in mammograms. The sealant, FloSeal, "is not recommenderd for use on breast tissue," Ward and colleagues wrote. Ward is Medical Director of Women's Health Imaging and an assistant professor in the Department of Radiology at Loyola University Chicago Stritch School of Medicine.

Full article available HERE.

CryoLife Announces Release Date and Teleconference Call Details for 2009 First Quarter Financial Results

CryoLife, Inc. (NYSE:CRY), an implantable biological medical device and tissue processing company, announced today that 2009 first quarter financial results will be released on Thursday, April 30, 2009. On that day, the Company will hold a teleconference call and live webcast at 10:00 a.m. Eastern Time to discuss the results, followed by a question and answer session hosted by Steven G. Anderson, president and chief executive officer of CryoLife, Inc.

To listen to the live teleconference, please dial 201-689-8261 a few minutes prior to 10:00 a.m. A replay of the teleconference will be available April 30 through May 7 and can be accessed by calling (toll free) 877-660-6853 or 201-612-7415. The account number for the replay is 244 and the conference number is 319410.

The live webcast and replay can be accessed by going to the Investor Relations section of the CryoLife web site at www.cryolife.com and selecting the heading Webcasts & Presentations.

Baxter International Inc. continuing partnership with the World Federation of Hemophilia

DEERFIELD, Ill.--(EON: Enhanced Online News)--In recognition of the 20^th anniversary of World Hemophilia Day, Baxter International Inc., in its continuing partnership with the World Federation of Hemophilia, today announced the availability of the “Together, We Care” video podcast (available at www.wfh.org/whd) to help raise awareness of the vital role of comprehensive care in hemophilia management and to call attention to disparities in care around the world. While research shows that comprehensive care reduces risk of death among hemophilia patients by 40 percent, tragically, only about 25 percent of all people living with hemophilia receive adequate treatment.^1,2

“Baxter is proud to contribute resources such as the ‘Together, We Care’ video podcast to encourage a global dialogue around these issues with the goal of improving the standard of care for all people living with hemophilia.”

“Hemophilia is serious, and can be life-threatening, but with a comprehensive care management approach, including treatment and care from a team of healthcare professionals, people with hemophilia can live longer, healthier lives,” said Mark Skinner, president, World Federation of Hemophilia. “We are grateful to Baxter for its support of the ‘Together, We Care’ video podcast, an important educational tool to help ensure that all patients with a bleeding disorder, regardless of where they live in the world, have access to proper management, care and treatment.”

The video podcast provides a forum for the World Federation of Hemophilia’s National Member Organizations, Baxter employees and community members worldwide to help advocate for local care of people living with hemophilia. It spotlights the importance of comprehensive care teams in improving these individuals’ lives through the perspectives of the patient, physician, nurse coordinator and advocacy group representative. The video podcast also builds on Baxter’s long-standing commitment to initiatives aimed at improving access for bleeding disorder patients.

CPC OF AMERICA INC

Below are edited highlights of CPC's 10-Q/A. 

To date, our activities have included the market analysis and development of our MedClose device and counterpulsation units and the raising of development and working capital. We have developed and prepared for market our counterpulsation units, including a stand-alone unit known as the CPCA 2000. In March 2003, we received FDA clearance to market the CPCA 2000 counterpulsation unit as a Class III medical device. We are also engaged in the business of developing a patented internal puncture closure device and technique known as "MedClose". We have not commenced revenue producing operations...........As previously disclosed in our reports filed with the SEC, in April 2007 we received a warning letter from the FDA which expressed, among other things, that:

· The FDA believed the MedClose device was a significant risk device and not eligible for investigation in the U.S. without an IDE approved by the FDA;

· We had violated IDE regulations governing the proper conduct of clinical studies, including our failure to provide the U.S. reviewing institutional review board's and clinical review site with information they needed to conduct the clinical investigation properly;

· We failed to provide accurate information about the investigations to the FDA and failed to provide to the FDA staff access to the sites pertaining to the MedClose; and

· We provide to the FDA certain information and records concerning our clinical studies.

We disagreed with the claims made by the FDA and filed an appropriate response with the agency. Meanwhile, we suspended human clinical investigations of the MedClose device in the U.S. pending further discussions with the FDA. During the remainder of 2007 and the first part of 2008, we engaged in an ongoing dialogue with the FDA for purposes of addressing its concerns and explaining our positions taken. On May 23, 2008, the FDA advised us by letter that our responses were satisfactory and that no further response to the FDA's warning letter was required. Based on the FDA's letter dated May 23, 2008 and subsequent written correspondence and discussions with the FDA staff, we believe the matter to be closed with no prospect of fine or penalty by the FDA. We also believe that we have addressed substantially all of the FDA's concerns over our human clinical trials and we expect to resume human clinical trials in the United States subject to the FDA's review and approval of our investigative device exemption (IDE) application. We submitted an IDE application to the FDA on November 30, 2007, which, if approved, will facilitate a continuance of the US clinical trials that were suspended by us in November 2006. In December 2007, the FDA responded to our IDE application with a disapproval letter. We have since filed three IDE supplements to address deficiencies cited by the FDA, the third of these was submitted on September 5, 2008. On October 8, 2008, the FDA responded to our third supplemental filing with two cited deficiencies. We are presently preparing a fourth supplemental filing for purposes of addressing the FDA's remaining comments. We estimate that the costs of conducting and completing clinical studies of the MedClose device to be between $178,000 to $430,000. We believe that we have sufficient working capital on hand to complete clinical studies. We intend to analyze our options for moving forward with the commercial exploitation of the MedClose, including licensing or sale of the product and our manufacture, marketing and sale of the product directly. If we pursue the manufacture or marketing of the MedClose product, we will, in all likelihood require significant additional capital. In that event we will endeavor to acquire the necessary working capital from the sale of our securities. However, there can be no assurance we will be able to obtain the required additional working capital on commercially reasonable terms or at all...........However, there are no agreements or understandings with any third parties at this time for our receipt of additional working capital and there can be no guarantee that such funds will be available on commercially reasonable terms, if at all. If we are unable to access additional capital on a timely basis, we will be unable to expand or continue our development of the MedClose device and our operating results will be adversely affected..... Full story HERE

Department of Defense Awards CryoLife $1.7 million to Develop BioFoam Hemostatic Technology

CryoLife, Inc., (NYSE: CRY) an implantable biological medical device and tissue processing company, today announced it has been awarded approximately $1.7 million under the Department of Defense (DoD) Appropriations Bill to continue further development of CryoLife's protein hydrogel technology. Preclinical studies of CryoLife's BioFoam(R) Surgical Matrix, a protein hydrogel product under development for organ sealing, are nearing completion. This grant will help fund upcoming clinical studies of BioFoam in the United States. In December 2008, CryoLife received conditional approval from the FDA to conduct the feasibility phase of the Company's BioFoam IDE submission for liver parenchyma sealing. Before beginning the feasibility study, the Company must receive final approval of the study protocol and related documents from the FDA and an additional approval of the same from the U.S. Department of Defense. The Company is in the final review process with the Department of Defense. The Company also filed a CE Mark submission with its Notified Body in December 2008 for BioFoam's use as an adjunct in the sealing of abdominal parenchymal tissues (liver and spleen) when cessation of bleeding by ligature or other conventional methods is ineffective or impractical. The Company also continues to conduct preclinical research with BioFoam for use in wound sealing in trauma surgery. "Over the past four fiscal years the DoD has allocated a total of approximately $5.4 million to CryoLife for the development of protein hydrogel products," said Steven G. Anderson, CryoLife president and chief executive officer. "We are excited about advancing this product through the clinical process.BioFoam, a protein hydrogel biomaterial under development by CryoLife, contains an expansion agent which generates a mixed-cell foam. The foam creates a mechanical barrier to decrease blood flow and minimize pores for the blood to enter, leading to cellular aggregation and enhanced hemostasis. It is easily applied and could potentially be used intraoperatively to control internal organ hemorrhage, limit blood loss, and reduce the need for future operations in liver resections. BioFoam is based on the same technology as BioGlue(R), a CryoLife product approved by the U. S. Food and Drug Administration to control bleeding as an adjunct to sutures and staples in open surgical repair of large vessels. BioGlue is also CE marked in the European Community and approved in Canada and Australia for use in soft tissue repair.

JnJ release Q1 results - edited

We completed our acquisition of Mentor Corporation at the end of January and we are moving full speed ahead on integration of Mentor and Omrix Biopharmaceuticals within our Ethicon Surgical business. We are making progress with the integration of health media and human performance institute as we advance our new wellness and prevention platform. This business is now being reported as part of the Consumer segments financial results. These and our other acquisitions like Dabao Cosmetics and SurgRX are adding important sales and growth opportunities to our business but I would remind you that this quarter and the years results will also reflect the divestiture of our professional wound care business which was sold in the fourth quarter of 2008. Ethicon worldwide sales grew operationally by 9.1% with the US up 18.8% and sales outside the US up 3.7% operationally. The acquisitions of Mentor and Omrix offset by the divestiture of the professional wound care business added approximately two points to the worldwide growth. Sales in the US on a pro-forma basis for our newly acquired aesthetics products from Mentor although lower then 2008 performed better then the estimated market. Strong double digit growth was achieved in meshes and bio-surgical.

Angiotech Pharmaceuticals, Inc. announces License Agreement with Baxter International Inc.

Angiotech Pharmaceuticals, Inc. (NASDAQ: ANPI, TSX: ANP) today announced it has completed an Amended and Restated Distribution and License Agreement with its partner Baxter International Inc. (Baxter). As consideration for the Amended and Restated Distribution and License Agreement, Angiotech will receive $25 million. Angiotech and Baxter initially entered into a Distribution and License Agreement in 2003 relating to certain intellectual property for Angiotech's COSEAL(R) surgical sealant. The Distribution and License Agreement entitled Baxter to market and sell COSEAL worldwide (excluding Japan), from which Angiotech has derived royalty revenue from Baxter. The Distribution and License Agreement also gave Baxter an option for distribution rights in Japan. As a result of this transaction, Baxter will obtain worldwide rights to COSEAL and certain additional fields of use for COSEAL, and expanded worldwide rights to COSEAL derivatives. Baxter will owe no further royalty or milestone obligations to Angiotech relating to the existing formulation of COSEAL or any future products under the terms of the Amended and Restated Distribution and License Agreement.

HemCon Patch

HemCon Medical Technologies offers a more flexible HemCon Patch designed for use for external, temporary control of bleeding during interventional and diagnostic cardiac catheterization, interventional radiology, electrophysiology and dialysis access procedures.

Offering diagnostic and interventional patients a quick, safe and comfortable post-procedural experience, the HemCon Patch delivers a flexible hemostatic solution where rapid arterial hemostasis is critically important to ensure quality care and safety. It stops bleeding and minimizes risk of artery damage. As one of the only hemostatic products to obtain an FDA antibacterial barrier claim, the HemCon Patch provides a barrier against a wide spectrum of micro-organisms, including methicillin-resistant Staphylococcus aureus (MRSA), Enterococcus faecalis (VRE) and Acinetobacter baumannii. This barrier may help to reduce the risk of hospital-acquired infections for both patients and providers. The HemCon Patch is also suited for patients that take anticoagulant medications or suffer from clotting or bleeding disorders.

US Congressional Sting Operation Exposes Gaps in Health System

Thousands of medical research groups that monitor clinical trials on behalf of the drug industry may face tougher regulations in the wake of a congressional sting operation that found gaps in the nation's oversight of experiments on humans.

The sting, detailed at a House Energy and Commerce Committee hearing Thursday, involved the creation of a fictitious company and a fake medical device, a surgical adhesive gel. The sham firm then applied to three for-profit oversight groups -- called institutional review boards, or IRBs -- for approval to begin a clinical trial using their adhesive on human subjects.

Drug and device makers along with hospitals and university research facilities must retain an independent IRB to oversee the methodology and safety issues for human studies. Corporations cannot get Food and Drug Administration approval for their products without an IRB certifying their clinical trials. About 6,350 IRBs are registered with the Department of Health and Human Services.

Lawmakers have raised concerns over whether IRBs routinely approve medical studies for paying clients. The committee leaders are considering whether to introduce a bill to strengthen IRB regulations.

Two IRBs contacted by the GAO's sting operators -- Argus IRB of Arizona and Fox IRB of Illinois -- rejected the Adhesiabloc proposal because of unanswered safety questions.

"We realized it was a terrible risk for the patient … It is the worst thing I have ever seen," an Argus IRB reviewer said, according to a slide shown at the hearing.

Coast IRB LLC of Colorado Springs, Colo., did approve a study for the fictitious adhesive gel, "Adhesiabloc." Five months after approving the study for abdominal surgery patients, Coast learned that neither Adhesiabloc nor its maker, Device Med-Systems of Virginia, existed.

Coast CEO Dan Dueber said in an interview that the congressional case was illegal entrapment. At the hearing, Mr. Dueber testified, "The GAO perpetrated an extensive fraud against my company. You pulled the wool over our eyes -- congratulations." Because the product was fake, it was never used.

As part of the sting, the committee also created a sham IRB to see whether the Department of Health and Human Services, which registers IRBs, would certify their fictitious group.

The committee, working with the Government Accountability Office, Congress's investigatory arm, named the CEO of the fake IRB Truper Dawg, after a staffer's three-legged dog, now deceased. Other fake names included "April Phuls" and "Timothy Wittless," which lawmakers said should have signaled irregularities to HHS. The department registered the IRB.

At Thursday's hearing, the toughest complaints were reserved for HHS. Rep. Joe Barton of Texas, the committee's ranking Republican, asked one HHS official: "Do you have any sense of outrage?" Referring to Coast, he continued, "What steps are being taken right now to decertify these charlatans?"

The director of HHS's office that registers review boards, Jerry Menikoff, said at the hearing that his bureau had only recently received the committee information about Coast, and would look into the matter.