Cryolife Q2 '09 - Edited

Product revenues which consists primarily of BioGlue and HemoStase increased 5% in the second quarter of '09 compared to the second quarter of '08 and increased 6% in the first half of '09 compared to the first half of '08. We had a very difficult prior year quarterly comp for BioGlue as the second quarter of last year was by far our best quarter during 2008.

BioGlue revenues were 12.4 million and 24.1 million for the second quarter in the first six months of '09 compared to 13 million and 24.9 million for the corresponding periods in '08. BioGlue revenues in the second quarter of '09 did improve over the first quarter of '09 with an increase of 5%.

Excluding the effects of changes in foreign currency exchange rates year-over-year which reduced BioGlue revenues by 331,000 and 639,000 in the second quarter and first six months of '09, BioGlue revenues would have been 12.7 million and 24.8 million.

HemoStase revenues for the second quarter and first six months of '09 were 1.5 million and 2.6 million. HemoStase was added to our product portfolio in the second quarter of '08.

Tissue processing and product gross margins were 63 and 64% for the second quarter and first six months of '09 compared to 66 and 65% for the corresponding periods in '08. We expected to see this decrease in gross margins as HemoStase sales which carry a lower gross margin than our recent aggregate gross margins continue to grow. And with some pricing pressure that we've seen as a result of the economy and it's effect on hospital purchasing patterns.

Tissue processing and product gross margins were 63 and 64% for the second quarter and first six months of '09 compared to 66 and 65% for the corresponding periods in '08. We expected to see this decrease in gross margins as HemoStase sales which carry a lower gross margin than our recent aggregate gross margins continue to grow. And with some pricing pressure that we've seen as a result of the economy and it's effect on hospital purchasing patterns.

Once we receive final IDE approval, our clinical study will evaluate BioFoam as an adjunct on cessation of bleeding by ligature or conventional methods is ineffective or impractical on liver parenchyma. This is a two part investigation including a feasibility phase followed by a pivotal phase. Both phases will be prospective, multi-center, randomized and controlled.

The feasibility phase of the investigation will be conducted at a maximum of two investigational sites. And we'll enroll 20 eligible subjects. The pivotal investigation will include a total of 164 eligible subjects, 82 subjects and each treatment group enrolled across a maximum of 10 investigational sites.

We believe that we can obtain commercial approval in approximately two to three years. We think the annual worldwide market opportunity for a product like BioFoam used for the sealing of abdominal parenchymal tissues is over a 100 million. We continue to evaluate other potential uses for BioFoam including its clinical utility in the treatment of traumatic injuries and in cardiovascular surgery.

Hemostat IFU and Brochure Downloads

For your information currently including J&J, Baxter, Vascular Solutions, Orthovita, SMI, Cryolife, further materials are welcomed along with updates (please send to hemostatguy@gmail.com) , all materials provided are and sent must be freely available online and from a verifiable email address. You may download or share by clicking on the thumbnails below..........Please Do view the sidebar Disclaimer also displayed below this post as all information is subject to change and is not for clinical use, always review the company/product information directly. No liability is accepted by this Author.

Disclaimer: All data and information provided on this site is for informational purposes only. I make no representations as to accuracy, completeness, currentness, suitability, or validity of any information on this site and will not be liable for any errors, omissions, or delays in this information or any losses, injuries, or damages arising from its display or use. All information is provided on an as-is basis.

Orthovita schedule Q2 date

Orthovita, Inc, a leading orthobiologics and biosurgery company, will hold a conference call on Thursday, August 6, 2009, at 8:30 a.m. Eastern Time, to review and discuss its financial results for the second quarter 2009 and update full year guidance. Antony Koblish, President and Chief Executive Officer, and Nancy C. Broadbent, Senior Vice President and Chief Financial Officer of Orthovita, will host the call.

The telephone number to join the conference call from within the U.S. is (888) 815-2919, and from outside the U.S. is (706) 643-3675. The conference identification number is 18137278. Participants should dial in ten minutes prior to the scheduled start time for the conference call.

A replay of the conference call will be available for two weeks beginning August 6, 2009, at 11:30 a.m. Eastern Time, and ending August 20, 2009, at 11:59 p.m. Eastern Time. You may listen to the replay by dialing within the U.S. (800) 642-1687 or by dialing from outside the U.S. (706) 645-9291. The replay identification number is 18137278.

Vascular Solutions - Q2

Net revenue from hemostat products (primarily consisting of the D-Stat(r) Dry, D-Stat Flowable and D-Stat Radial products) was $6.4 million during the second quarter, an increase of 6% over the second quarter of 2008. "The two principal reasons for our sales growth in hemostat products were the exit of a competitor's patch product from the market and the growing sales of our new 'Wrap' version of the D-Stat Dry," commented CEO Mr. Root.

Blood Transfusion and Blood Conservation in Cardiac Surgery - Clinical Paper

Another Reader supplied article Perioperative Blood Transfusion and Blood Conservation in Cardiac Surgery - Society of Thoracic Surgeons and Society of Cardiovascular Anesthesiologists.

You may view or download by clicking on the thumbnail.

Thrombin - Presentation

Courtesy of a reader....

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Clinical Papers

Dear Reader,

I am inviting submissions for inclusion under the new label of "Clinical Papers" as per the paper below. If you have an article you feel would be useful or of interest please feel free to submit to me directly at hemostatguy@gmail.com

EMS, Surgical, Topical, Sealant, Glue and intravenous articles are all welcomed!

Clinical Benefits and Risks of Topical Hemostats: A Review

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ADVTX Announces New Treatment for Bleeding After Nuclear Exposure

Fibrinoplate-S a viable alternative to platelet transfusion for survivors of near-lethal doses of radiation

ANAHEIM, Calif.--(BUSINESS WIRE)--Advanced Therapeutics & Co. (ADVTX) announced today that Fibrinoplate-S™ has shown efficacy in reducing the bleeding in animals exposed to extreme doses of radiation. Survivors of a nuclear event or a dirty bomb explosion will have similar damage from the ionizing radiation of such bombs.

“Acute radiation can severely damage the bone marrow,” Richard Yen, Ph.D., M.D., CEO of ADVTX explained. “While existing medications can boost the production of red cells and white cells from the recovering bone marrow, there is no effective treatment for low concentrations of platelets except through platelet transfusion. Donor platelets, however, may not be available or adequately screened for pathogens during times of distress.”

Viable Alternative to Platelet Transfusion

ADVTX Fibrinoplate-S, a suspension formulation of human albumin spheres coated with a coagulation factor (fibrinogen), mimics the action of activated platelets. Random clots have not been observed even as bleeding improves after the administration of Fibrinoplate-S.

In preclinical trials, Fibrinoplate-S reduced bleeding within 2 hours after a bolus intravenous administration in test subjects with less than 1% of the normal platelet count. The beneficial effects last at least 24 hours. There is no need to match the recipients’ blood types. Fibrinoplate-S can be given to a large number of patients quickly.

Availability

ADVTX can scale up its production of Fibrinoplate-S quickly. Government agencies may include Fibrinoplate-S in their emergency response plans by submitting a “pre-EUA” (pre-Emergency Use Approval) to the US FDA. Licensing outside the United States is available. Visit www.ADVTX.com.

Baxter Q2 - Edited

In the second quarter, BioScience revenues totaled $1.4 billion, which represents a 2 percent increase over the prior-year period. Excluding foreign currency, BioScience sales advanced 13 percent, reflecting strong double-digit gains across several core franchises, which offset weak sales of the company's FSME vaccine, primarily in Germany. Key drivers of this performance include robust growth of antibody therapies and other specialty plasma therapeutics, strong sales of recombinant therapies, including ADVATE [Antihemophilic Factor (Recombinant), Plasma/Albumin-Free Method] for the treatment of hemophilia, as well as biosurgery products.....

Advancing Innovation and Expanding Product Offering -

Initiation of a Phase III study following successful completion of a Phase II study evaluating TISSEEL fibrin sealant as a hemostatic agent in vascular surgery. These studies are being conducted for submission to the Food and Drug Administration (FDA) to support a broad hemostasis indication for this product in the United States.

Robert L. Parkinson, Jr.

Without getting into some specific rates, let me say this. In most developed markets around the world there continues to be some opportunity to convert from plasma-derived Factor VIII to recombinant forms. A great example would be Japan, which still has a fairly high—I believe it's around 30% of their usage is still in plasma-derived Factor VIII but that is converting fairly rapidly to recombinant forms, which is one of the reasons why our ADVATE is doing so well in Japan.

In other developed markets, Western Europe and the U.S., you know, we're getting in the areas of diminishing returns, I think, in terms of use of plasma-derived Factor VIII and the opportunity to upgrade to recombinant forms. Although there does seem to continue to be some residual buying. Germany is a good example in Europe, which still uses quite a bit of plasma-derived Factor VIII.

I think the real opportunity that you alluded to in your question is what we call rest of world. Okay? And first of all, in emerging developing markets around the world, for the first time hemophilia is being treated to some meaningful degree, obviously with plasma-derived Factor VIII, so the first opportunity is just patients that previously weren't treated are not being treated with plasma-derived as those economies develop and as they allocate more of their national budgets to health care spending.

All of that plasma-derived adoption, of course, represents opportunity longer term to upgrade to recombinant forms, which is why we're re registering products like RECOMBINATE and ADVATE in China and so on. Most usage in China today is plasma-derived Factor VIII and there are many patients in China that aren't being treated.

So those are examples of the long-term opportunity, frankly, that are quite exciting. First of all, adopting plasma-derived Factor VIII and then over time setting the stage for upgrade conversions to recombinant forms.

So the big opportunity is really the rest of the world. There are selective residual opportunities—I mentioned Japan, Germany, and some of the other developed markets—for continued conversion from plasma-derived to recombinant forms.

CSL, Baxter Sued Over Accusations of Blood Monopoly

July 16 (Bloomberg) -- CSL Ltd. and Baxter International Inc. were sued by a Missouri hospital over allegations they conspired to fix and raise prices for blood plasma products.

The companies used key words to encourage each other to increase supply only incrementally to keep pace with demand and not to increase supply to the extent the companies actually compete for market share, lawyers for Pemiscot Memorial Hospital, based in Hayti, Missouri, said in a complaint filed yesterday. The lawsuit was filed in Philadelphia federal court.

“As a result of the conspiracy, prices for blood plasma products were higher than they otherwise would have been,” Marc Machiz, an attorney for Pemiscot, said in the complaint. “Beginning in 2005 and continuing through the present, prices for blood plasma proteins have increased substantially.”

Baxter and Melbourne-based CSL are the world’s largest makers of blood plasma products. Last month CSL abandoned a $3.1 billion bid for Talecris Biotherapeutics Holdings Corp. after regulators blocked the plan.

The deal would have helped CSL overtake Deerfield, Illinois-based Baxter as the leader in the $15 billion global market for blood plasma-derived medical treatments such as immunoglobin, used to treat patients with weakened immune systems.

FTC Lawsuit

The U.S. Federal Trade Commission earlier sued to stop CSL’s proposed acquisition over claims the deal would leave the two largest companies with 80 percent of the U.S. market for blood plasma products.

Baxter spokesman Chris Bona said the company wasn’t aware of the lawsuit and declined further comment. Robin Gilliland, an outside spokesman for CSL, said the company hasn’t seen the complaint and has no comment.

Pemiscot’s complaint seeks to represent purchasers of blood plasma proteins in the U.S. from Oct. 1, 2004, to the present. The complaint is also seeking unspecified damages.

The FTC said last month that the plasma protein industry showed “troubling signs of coordinated behavior,” according to Pemiscot’s complaint. The FTC’s complaint describes signals between the two companies suggesting that increasing production of blood plasma products could hurt their ability to reap significant profits, according to Pemiscot’s complaint.

Zymogenetics - Conference Call and Webcast Information

ZymoGenetics 2009 Second Quarter Financial Results Conference Call will be held on August 3, 2009 at 4:30 p.m. Eastern Time and may be accessed at www.zymogenetics.com or by dialing: 877-407-0778 (International: 201-689-8565). Participants should dial in to the call approximately 10 minutes prior to the scheduled start time to register. A live audio webcast and slide presentation can be accessed by going to: www.zymogenetics.com. The webcast will be archived for 60 days. For replay, please visit www.zymogenetics.com

J&J Q2 - Edited

........our medical device business saw strong growth in orthopedics and surgery and excluding the impact of additional competitors in the drug eluting stent market, the MD&D segment grew nearly 6% operationally for the quarter..........Ethicon endo-surgery achieved operational growth of 6.3% in the second quarter of 2009, with the U.S. sales growing 1% and sales outside the U.S. growing on an operational basis by 10.7%.

Harmonic technology business achieved strong double-digit operational growth due to the global success of recently launched products and the underlying strength of this platform. Additionally in the U.S., strong growth for the realized gastric band and the newly acquired [N-Seal] products contributed to the results. This was partially offset by lower sales in the U.S. for advanced sterilization products, or ASP, which had been impacted by tighter capital budgets in the hospitals...........

Source: SeekingAlpha

CryoLife Announces Release Date and Teleconference Call Details for Q2

ATLANTA, July 13 /PRNewswire-FirstCall/ -- CryoLife, Inc. (NYSE: CRY) ,an implantable biological medical device and cardiovascular tissue processing company,announced today that 2009 second quarter financial results will be released on Thursday, July 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 chi executive officer of CryoLife, Inc.

To listen to the live teleefconference, please dial 201-689-8261 a few minutes prior to 10:00 a.m. A replay of the teleconference will be available July 30 through August 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 327576.

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

FDA Reevaluates Safety of Plasma-derived Biologic Products

June 16, 2009 — The US Food and Drug Administration (FDA) Transmissible Spongiform Encephalopathies Advisory Committee has decided that no changes to blood-monitoring practices are required at this time. The committee met Friday to evaluate the risk for variant Creutzfeldt-Jakob disease (vCJD) in plasma-derived factor VIII products used for blood-clotting disorders.
Concern for patients was first sparked by a February announcement by health authorities in the United Kingdom reporting a vCJD infection in a person with hemophilia treated with a plasma product.
The FDA is now reevaluating whether current blood-donor policies are sufficient to maintain the safety of plasma-derived biologic products. The decision is anticipated to have international implications, because an estimated 50% of the world's plasma supply is provided by the United States.
Jay Epstein, director of the FDA's office of blood research and review, asked the committee if the UK announcement has "changed the landscape in a fundamental way" and should prompt changes in the United States.
The advisory committee voted unanimously that no changes are required at this time. The 15 voting members concluded that the risk for vCJD to patients who receive US-licensed plasma-derived coagulation factor VIII products is likely to be extremely small.
Committee chair Nick Hogan, MD, from the University of Texas Southwestern Medical School, in Dallas, said, "There is very little change to the modeling and epidemiological data, so there is very little reason to change this."
But during the open public hearing, some voiced concerns about the difficulty of reporting vCJD in many parts of the United States. Without thorough reporting, they question the accuracy of current data.

More Data Needed

The fatal neurodegenerative disease is acquired through infection with the agent that causes bovine spongiform encephalopathy. vCJD is typically acquired by consuming beef products from infected cattle. The first human cases of vCJD were reported in the United Kingdom in 1996. By May 2009, 211 definite or probable clinical cases of vCJD had been reported worldwide, with 168 of these in the United Kingdom.
At the open public hearing, some also raised concerns about inadequate animal surveillance. While countries such as Japan reportedly test every cow, this does not happen in many places, including the United States.
International health authorities have also been concerned about the risk for a secondary epidemic through human-to-human transmission. In the case that prompted the announcement in the United Kingdom, a 70 year-old man had been treated 11 years earlier with a plasma-derived factor VIII product. The product was reportedly developed from pooled plasma containing at least 1 donation from a person who later died of vCJD.
Postmortem examination of the 70-year-old's brain identified no neuropathological changes suggestive of Creutzfeldt-Jakob; however, his spleen revealed abnormal accumulations of prion protein typical of the disease.

Risk Likely Small

Mark Skinner, president of the World Federation of Hemophilia, said that he agrees with the advisory committee's decision. "While the risk may not be zero, it certainly is very small," he said at the meeting.
He suggests that current donor-deferral measures appear to be effective, but a donor screening test could still be useful. Mr. Skinner recommended that product warning labels should be updated to include vCJD among risk factors.
The committee discussed donor-deferral measures and product labeling at length but did not vote on these issues.
The FDA is considering the input from the advisory committee and will issue a final decision after its review.

Glues tailored to specific tissues

Surgical adhesives, which can be used to seal tissues after an operation or to repair wounds, are becoming increasingly important parts of a doctor's toolkit. However, their one-size-fits-all nature means that existing adhesives, or glues, work well in some cases but not in others.

Images showing the interface between a surgical glue (green) and tissue samples (red, blue and black) from the heart, lung, liver, and duodenum. The glue works best with duodenum tissue (note smooth interface), and worst with lung tissue (pockmarked with holes).

MIT researchers aim to change that with glues tailored to specific tissues. In a recent issue of Advanced Materials, they identified for the first time how one kind of glue material bonds to tissue and how that adhesion varies depending on the tissue involved, from the intestine to the lung. They then showed how by adjusting certain properties of the materials it was possible to create a range of adhesives optimized for specific tissues and applications.

"The delineation of tissue-specific mechanisms for material adhesion leads the way for tailoring materials to individual needs and applications. This exciting work may well change the clinical use and continued evolution of soft-tissue sealants and adhesive materials," said Elazer R. Edelman, principal investigator and MIT's Thomas D. and Virginia W. Cabot Professor of Health Sciences and Technology.

Adhesive sealants could improve patient care and reduce healthcare costs by cutting medical complications after surgery, such as leakage through incisions, and improved wound healing, according to Natalie Artzi, a postdoctoral associate who led the research in Edelman's lab.

Although there is already a billion-dollar market for such adhesives, "they haven't reached their true potential," Artzi said. Existing materials have limitations that often force doctors to compromise between adhesion strength and tissue reaction. For example, said Artzi, for a given tissue, the material may be adhesive but release toxins that could affect healing. Alternatively, the material could be quite tissue compatible, but degrade quickly, becoming non-adhesive. If the glue doesn't work, a doctor must switch to sutures or staples.

The problem, according to the MIT team is that while surgical adhesives rely on intimate interactions between the adhesive and the tissue in question, the properties of the target tissue have been largely ignored in designing adhesives. Instead, "one general formulation is proposed for application to the full range of soft tissues across diverse clinical applications," Artzi and colleagues wrote in their Advanced Materials paper.

The new work characterized a variety of interactions between one kind of glue (hyrogels composed of polyethylene glycol and dextran aldehyde, or PEG: dextran for short) and tissue from a rat's heart, lung, liver and duodenum (the first section of the intestine). The team found, for example, that the glue worked well with tissue from the duodenum, but poorly with that from the lung.

They then went on to "identify the functional groups in the material that are responsible for adhesion with tissue functional groups, and created a model to optimize adhesion for each tissue," Artzi said. In particular the paper explains how variation of chemical reactive groups in the material could be matched to the variability in the density of respective reactive groups on different tissues to regulate tissue-material interaction.

The team will use these findings to "develop a platform of adhesive materials" for specific tissues. Although it could take three to five years before the work translates into a product, "the concept is there," she concluded.

In addition to Edelman and Artzi, co-authors of the paper are Tarek Shazly (co-first author with Artzi and a graduate student in MIT's Department of Materials Science and Engineering), Aaron B. Baker (a postdoctoral associate in Edelman's lab), and Adriana Bon, now at the Universitat Ramon Llull (Spain).

The work was supported by the MIT-DuPont Alliance and the National Institutes of Health, as well as the Philip Morris External Research Program.

New Ultra-Thin Surgical Patch Has Endless Possibilities

Throughout the decades, surgeons have typically used stitches and staples to close up wounds. They may even use sheets several millimeters thick coated with fibrin, a protein that makes blood clot and is glue-like but which can cause unwanted sticking to nearby tissue.

Now, Japanese scientists have revealed a new, cutting edge surgical ‘nano-sheet’ they have developed that is one thousand times thinner than Cellophane that can patch up internal wounds before dissolving inside the body.

This transparent adhesive sheeting is made from a substance derived from crab shells and a viscous gum from algae and is only 75 nanometers thick. A nanometer is one-billionth of one meter.

"This is the world's thinnest adhesive plaster," said Toshinori Fujie, a researcher involved in the joint project by Tokyo's private Waseda University and the National Defense Medical College.


"We know food Cellophane clings on to the surface of various objects. We have made a sheet ultimately thin... so that it is highly flexible and can stick to organs well with no glue," he told AFP.

The experiment, which was repeated several times, consisted of using the new nano-sheet to patch a six-millimeter-wide hole in a dog’s lung.

The sheet proved to have the strength to stand up under the pressure of the dog’s respiration and allow the wounds to heal within a month without a visible trace, according to Fujie.

Researchers hope to launch human clinical trials in three years.

The sheets might also prove to be useful in treating external wounds in the future as well.

"Organs repaired with this sheet do not have scars, unlike after stitches," Fujie said. "We believe this could also be true on the skin."

If the tests show that it is effective externally, it could open up a world of applications such as being applied to wounds from surgery in breast cancer patients, he said.

"Some people also want to use this for treating bed sores. The next application will definitely be on the skin," he said.

Fujie says that the inventors have been exploring all possibilities, even cosmetic uses such as stretching out wrinkles or holding skin conditioners in place.

"As this is transparent on the skin, you could be wearing a face pack while working in the office," he said.

Analyst predicts - "high-strength, elastic glue without toxicity concerns would revolutionize the market"

Approximately 70 million surgical and procedure-based wounds are created each year in surgeries worldwide that offer potential for adjunctive products for surgical closure and securement. Some 23 million of these wounds are created during surgical procedures in the United States. Although it is possible that healing of all these wounds would be improved through use of adjunctive products for surgical closure and securement, use of the most advanced of these products has been limited to a fraction of these procedures. For example, there are approximately 3 million procedures which receive sealant products around the world, generating $1.6 billion in sales in 2007. We forecast much greater usage of sealants once clinical efficacy is proven in a broad range of procedures. New sealant products are also being launched. In addition to improvements in adjunctive treatment of bleeding, new procedure-enabling devices for soft tissue repair and securement have been introduced. These products have expanded the total market for securement and closure of soft tissues with bioresorbable materials.

This field is expanding rapidly as new devices allow the surgeon to perform closure more quickly and with improved outcomes for patients. A significant premium is possible when new products and devices enable complex securement procedures to be performed under minimally invasive protocols with significant time-savings in the operating room. New technologies and new biomaterials allow improved tissue repair, and it is possible to revalue segments of this market based on significant improvements in clinical practice. We expect this market segment to triple in value over the next decade.

The total market potential by 2013, driven by procedure volumes, for hemostats, sealants, and glues, addressable by currently available products, nearly $4.5 billion for hemostats and sealants, and more than $1.3 billion for skin wound closure using high-strength glues. The introduction of a high-strength, elastic glue without toxicity concerns would revolutionize the market further and lead to even higher sales potential.

Source: MedMarket Diligence, LLC

Thrombin involved in Myocardial Ischemia-Reperfusion Injury

Several lines of experimental evidence specifically implicate thrombin to be involved in myocardial ischemia-reperfusion injury. Cardiopulmonary bypass increases thrombin generation progressively, but reperfusion after myocardial ischemia induces an additional distinct and rapid increase in thrombin generation. Clinical studies have shown that thrombin formation during cardiac surgery, especially during myocardial reperfusion, is involved with myocardial damage and impaired hemodynamic recovery. Therefore, strategies to improve thrombin control during cardiopulmonary bypass might be beneficial..........article available HERE

FDA Public Health Notification: Paralysis from Absorbable Hemostatic Agent

Dear Surgeon:

This is to remind you of a rare but devastating adverse event that can occur with the use of an absorbable hemostatic agent, a device used to promote coagulation and stop internal bleeding during surgical procedures. Unfortunately, these events continue to occur despite specific advice and warnings in the device labeling. We ask that you take action to minimize the risk in your patients and help spread the message in this announcement.

Nature of Problem

Since 1996, FDA has received reports of over 110 adverse events related to absorbable hemostatic agents. Eleven of the events resulted in paralysis or other neural deficits. The last reported paralysis occurred in October, 2003. The common thread in all 11 events was an absorbable hemostatic agent that was used on or near a bony or neural space and left inside the patient. When wetted, the material swelled and exerted pressure on the spinal cord or other neural structures, resulting in pain, numbness or paralysis. In some cases, blood pooled behind the implanted absorbable hemostatic agents, forming a hematoma that exerted pressure on neural tissues and caused a range of neural deficits.

Although these events are rare, they can have serious consequences. These consequences are preventable.

Recommendations

FDA recommends that users of absorbable hemostatic agents review the device labeling, especially the contraindications, warnings and precautions.

If you use an absorbable hemostatic agent on or near bony or neural spaces:

• use the minimum amount necessary to achieve hemostasis; and,
• remove as much of the agent as possible after hemostasis is achieved.

This will reduce the likelihood of neural and other soft tissue damage from swelling of the absorbable hemostatic agent, and/or migration and swelling of fragments of the agent.

Reporting Adverse Events to FDA

FDA requires hospitals and other user facilities to report deaths and serious injuries associated with the use of medical devices. If you suspect that a reportable adverse event was related to the use of an absorbable hemostatic agent, you should follow the reporting procedure established by your facility.

We also encourage you to report adverse events related to absorbable hemostatic agents that do not meet the requirements for mandatory reporting. You can report these directly to the device manufacturer. You can also report to MedWatch, the FDA’s voluntary reporting program. You may submit reports to MedWatch by phone at 1-800-FDA-1088; by FAX at 1-800-FDA-0178; by mail to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD 20857-9787; or online.

Getting More Information

If you have questions about this notification, please contact Ms. Quynh Hoang, Office of Surveillance and Biometrics (HFZ-510), 1350 Piccard Drive, Rockville, Maryland, 20850, Fax at 240-276-3356, or by e-mail at phann@cdrh.fda.gov. You may also leave a voice mail message at 240-276-3357 and we will return your call as soon as possible.

FDA medical device Public Health Notifications are available on the Internet. You can also be notified through email on the day the safety notification is released by subscribing to our listserv. To subscribe, visit: http://service.govdelivery.com/service/subscribe.html?code=USFDACDRH_10.

Sincerely yours, David W. Feigal, Jr., MD, MPH Director Center for Devices and Radiological Health Food and Drug Administration Issued: 4-2-2004