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.

Clottocytes: Artificial Mechanical Platelets

While to some Robert A. Freitas Jr.'s clottocyte technology may resemble science-fiction recent developments in the hemostasis field lend his ideas more credibility.............The artificial mechanical platelet or clottocyte may allow complete hemostasis in as little as ~1 second, even in moderately large wounds. This response time is on the order of 100-1000 times faster than the natural system. Our baseline clottocyte is conceived as a serum oxyglucose-powered spherical nanorobot ~2 microns in diameter (~4 micron3 volume) containing a fiber mesh that is compactly folded onboard. Upon command from its control computer, the device promptly unfurls its mesh packet in the immediate vicinity of an injured blood vessel — following, say, a cut through the skin. Soluble thin films coating certain parts of the mesh dissolve upon contact with plasma water, revealing sticky sections (e.g., complementary to blood group antigens unique to red cell surfaces) in desired patterns. Blood cells are immediately trapped in the overlapping artificial nettings released by multiple neighboring activated clottocytes, and bleeding halts at once.......................................Read more HERE

Who else is interested in Nanotech? ........Hemcon, Alltracel

HemCon's acquisition of Alltracel gives access to Alltracel's joint venture with Elmarco and its proprietary nanotechnology manufacturing process called Nanospider®. HemCon will seek to leverage this process to aggressively grow its market share in acute wound care products developed from chitosan.

Elmarco is a specialist R&D and manufacturing company that has developed, in conjunction with the Technical University of Liberic, a novel proprietary & patented process for spinning polymers into nano-scale fibres for a range of industrial, chemical, micro-electronic and bio-medical applications. This proprietary technology branded Nanospider", represents a major breakthrough in the mass production of nanofibre materials and is now deployed in a number of markets including medical products.
NANOPEUTICS headquartered in Liberic in the Czech Republic and operating internationally has been assigned the relevant woundcare and Nanospider(TM) intellectual property and patents and has already been in advanced discussions including successful product testing with a number of existing consumer and professional woundcare companies.

Nanoparticle Laden High-Tech Gauze Looks To Save Lives

Nanoparticles are one of the hottest fields of studies. These tiny molecules promise to revolutionize everything from medicine, to computing, to power, to water purification. The diverse uses being discovered are only limited by the difficulties in bringing this incredibly promising technology to market.
Now the scientific community is enthralled by a perhaps unexpected new use of the particles -- high-tech gauze. By using a special gauze fabric, permeated with Kaolin clay which is rich in aluminosilicate nanoparticles, scientists have discovered they can dramatically inducing clotting that is nothing short of a medical miracle.
The gauze bandage is easy to apply and greatly improves clotting in hard to apply regions such as the neck or groin. This makes it ideal for the battlefield. In recent conflicts, such as the Iraq war, many of the casualties have been due to blood loss. The new gauze could soon be saving lives.
Richard McCarron, head of trauma and resuscitative medicine at the Naval Medical Research Center in Maryland stated, "We are currently testing bandages because hemorrhage is a leading cause of death in military trauma patients. The recent tests with Combat Gauze indicate that it decreased blood loss and improved survival."
Z-Medica, a medical products company located in Connecticut, manufactures the high tech gauze. Z-Medica CEO Ray Huey says the new gauze has already saved two lives. Huey describes his company's start, stating, "In 2002, following the September 11 attacks, the military was looking at new technologies to stop bleeding."
The company easily won the Navy's test of high-tech medical products, according to Huey, when Z-Medica debuted its first product, QuikClot, a special powder dumped on wounds to induce clotting. The powder is currently in use in Afghanistan and Iraq. However, despite saving lives QuikClot had some nasty side effects. During the clotting process, the powder heated up enough to cause burns, which many of the soldiers complained of. While burns were better than dying, Z-Medica went back to work looking for a better solution.
A leading materials researcher Galen Stucky led a team of several graduate students and collaborated with Z-Medica to solve the problem. Stucky's solution was to instead use a material frequently used in medical testing -- Kaolin Clay. The clay's nanoparticles trigger clotting.
Graduate student April Sawvel explains, "Kaolin clay has been used since the 1950s as an activating agent for a clotting test that medical doctors routinely perform. We tested it against the original granular QuikClot and discovered that it worked just as well, but without the large heat release associated with the original QuikClot formulation."
While some nanoparticles are thought to possibly be hazardous, there is little known risk from aluminosilicate nanoparticles, which have been frequently which mankind has been in contact with since its early days. Further, the nanoparticles are trapped by the clot at the site of the injury, so should have little chance of traveling into the body.
Having found the new material the team found that it was much easier to use it, when it was added to gauze, instead of a powder. Huey describes, "We immediately started looking at ways to impregnate gauze with this material. We very quickly prototyped some material. When I say very quickly, I mean within less than two weeks."

The video below shows the original Quikclot.

Wound-Sealing, Self-Assembling, Nanoscale Technology

A super-stealthy MIT (Massachusetts Institute of Technology) spinoff is poking its head out today to announce that it has finalized a licensing agreement with the Institute. The pact gives Arch Therapeutics rights to a family of clear liquids developed by research scientist Rutledge Ellis-Behnke that stanch or prevent bleeding after an injury or during surgery.

Ellis-Behnke and his colleagues had started out working with the liquids, which are packed with tiny protein fragments, or peptides, as potential aids to the regeneration of damaged neural tissue; they discovered in the course of brain surgeries on lab animals that some of the peptides stopped bleeding—within just 15 seconds. It turned out that what was happening was the nanoscale peptides were self-assembling into a biodegradable gel that sealed the wound on contact.

Around the same time as that work was published in 2006, Ellis-Behnke founded Arch—which then went by the perhaps-too-literal Clear Nano Solutions—with healthcare investment veteran Terrence Norchi and Steve Kelly, a serial entrepreneur and founding CEO of Myomo, another MIT spinoff. (Both Myomo’s founders and Ellis-Behnke have received grants from MIT’s Deshpande Center for Technological Innovation.) The company still has yet to ink any venture financing deals; in an article in Mass High Tech written shortly after the company’s founding, Kelly was identified as the sole investor in the firm.

It’s still early days, but Arch materials might eventually be used in the operating room, on the battle field, or even in first-aid kits. Says former Cleveland Clinic head and Arch advisor Floyd D. Loop in a press release: “Discovering ways to control something so fundamental as bleeding has potentially huge implications for the medical field.”
I had trouble viewing the 2006 Pdf full description at its web location so I have made it public hosting it at http://www.adrive.com/ and it is available HERE.

Cryolife BioGlue for Abdominal Aortic Aneurysm Repair

10% of people given fibrinogen have HCV

The Yomiuri Shimbun
About 10 percent of the 7,400 or so patients who were administered the blood product fibrinogen were infected with hepatitis C, a Health, Labor and Welfare Ministry study team announced Tuesday.
The team has been investigating patient records kept at medical institutions to which fibrinogen was shipped. The product was made by Green Cross Corp., a predecessor of Mitsubishi Tanabe Pharma Corp.
An estimated 10,000 people are thought to have been infected with the hepatitis C virus after the blood product fibrinogen was used in surgical operations involving about 280,000 people. However, the results of the investigation suggest this percentage of infection, 3.6 percent, could be lower than the true figure, medical sources said.
In its interim report, the study team found 99 people infected after being treated with fibrinogen have died from hepatitis-related diseases.
Fibrin glue, used as a surgical adhesive, was the most common use of fibrinogen among patients, making up about 40 percent of cases. Direct intravenous injection of fibrinogen as a hemostat agent in operations, including parturitions, accounted for 30 percent of treatments involving the product.
The survey results prompted the ministry to renew its call for people who have had surgery to have hepatitis checkups.
Out of 6,609 medical institutions to which Green Cross delivered the product, 644 institutions that kept individual patients' records of administration of fibrinogen were surveyed at the end of February. Of them, 475 institutions provided valid responses.
According to the survey, 7,406 patients were administered fibrinogen, and 741 of them were found to have been infected with HCV. Of them, 12 also had been infected with the hepatitis B virus, while 40 others had been infected with HBV alone.
Hospitals are unsure whether 4,908 of the 7,406 patients have hepatitis. The number of people found to have been infected likely will further rise as the investigation progresses, the medical sources said.
Of patients administered fibrinogen, 1,817, or 24.5 percent, have already died. Of them, 99 died from hepatitis-related diseases.

Entegrion achieve FDA approval

Entegrion, Inc., a privately owned life sciences product development company specializing in technologies for hemorrhage control, resuscitation, and tissue repair, announced that it has received 510(k) market approval from the U. S. Food and Drug Administration (FDA) for its hemostatic medical textile technology. The first application of the technology is Stasilon FR – hemostatic wound dressings for first responders. This market includes EMS workers, police officers, emergency personnel and fire fighters. The Stasilon FR – hemostatic wound dressing was approved by the FDA for use by medical professionals under prescription and “over-the-counter” by consumers to control bleeding resulting from “minor cuts and abrasions” as well as “lacerations, punctures and incisions.” Pending acceptance of an amendment to the FDA approval, a second version of the technology will be implemented as Stasilon OR – hemostatic surgical pads.
Entegrion 510K available HERE

CryoLife to Distribute FDA-approved Hemostatic Agent Under Private Label

ATLANTA, April 17 /PRNewswire/ --
CryoLife, Inc. (NYSE: CRY), a biomaterials, medical device and tissue
processing company, announced today that it has signed an exclusive
three-year agreement with Minneapolis-based Medafor, Inc.

Under terms of the agreement CryoLife will distribute Medafor's microporous polysaccharide hemostatic agent for use in cardiac and vascular surgery in the U.S. and for cardiac, vascular and general surgery, other than orthopaedic and ear, nose and throat surgery, outside the U.S. (excluding Japan and China). CryoLife expects to begin distributing Hemostase MPH in the U.S. in the second quarter of 2008, except to approximately 41 hospitals for which Medafor will retain distribution rights until no later than December 31, 2008. Outside of the U.S., CryoLife expects to begin distributing Hemostase MPH in Canada, United Kingdom and Germany in the second quarter of 2008, with distribution in other markets beginning in 2009. Department of Defense hospitals are excluded from CryoLife's territory under the distribution agreement, but Veterans' Administration Hospitals are included. The unique, absorbable powder hemostat, which received CE Mark approval in 2003 and FDA pre-market approval in September 2006, will be distributed by CryoLife under the private label name Hemostase MPH. Hemostase MPH is developed using Medafor's exclusive, licensed Microporous Polysaccharide Hemospheres technology (MPH(R)), which yields a plant-based, flowable powder engineered to rapidly dehydrate blood, enhancing clotting on contact. When used as directed, this highly effective hemostatic agent facilitates the formation of a resilient, natural clot within just a few minutes. Available in a convenient ready-to-use applicator, Hemostase MPH, unlike many hemostatic agents, does not require additional preparation steps in the operating room or special storage conditions thereby saving valuable operating room time and resources. Pre-clinical evaluations have shown that Hemostase MPH does not promote infection and absorbs within 24-48 hours of application at the wound site, compared to other surgical hemostats which can take 3-8 weeks or more to fully break down. "Hemostase MPH gives surgeons the ability to quickly control active surgical bleeding, making it the perfect complement to CryoLife's BioGlue(R) product line, which is much stronger and provides both tissue reinforcement and sealant capabilities," stated Steven G. Anderson, president and chief executive officer. "Hemostase MPH also allows us to compete in the surgical hemostat market, which we believe totaled approximately US$380 million in the U.S. in 2007." Gary Shope, Medafor's chief executive, said, "We are pleased to be working with CryoLife as a major distribution partner. CryoLife is a world leader in its chosen areas, and its strength in sales, marketing and distribution in the cardio and vascular fields should provide great impetus to Medafor's market penetration." The agreement allows for a three-year extension at the option of CryoLife if certain minimum purchases are met.

Orthovita Introduces VITASURE™ Absorbable Hemostat

Orthovita, Inc. (NASDAQ:VITA), a spine and orthopedic biosurgery company, announced today that it has obtained certain rights to distribute an absorbable hemostat product developed by Medafor, Inc., a Minneapolis-based medical device company. The product is approved for use as a hemostat in certain surgical procedures under a pre-market approval granted by the U.S. Food and Drug Administration in 2006 and a CE Mark granted in 2003. Orthovita plans to rebrand the product as VITASURE™ Absorbable Hemostat.

VITASURE’s hemostatic mechanism of action is based on Medafor’s exclusively licensed microporous polysaccharide hemosphere technology. Through this technology, VITASURE acts as a molecular sieve to instantly extract fluids from blood, creating a powerful osmotic action that causes the particles to swell and concentrates serum proteins, platelets, and other formed elements on its surface. The VITASURE particles and their coating of compacted cells then create a matrix for the formation of a tenacious fibrin clot. The VITASURE particles are fully absorbed and enzymatically cleared within 24-48 hours.
Under its distribution agreement with Medafor, Orthovita has the non-exclusive right to sell VITASURE in the spine and orthopedic field in the United States, and certain territories outside of the United States. Medafor has responsibility for manufacturing and maintaining regulatory approvals for the product. The initial term of the agreement is scheduled to expire in December 2013 and Orthovita has the right to renew the agreement for an additional three year period if certain purchase obligations are met during the fifth year of the agreement.