Study: Closure devices cut complications after cardiac procedure (VIDEO)

The use of vascular closure devices significantly reduced complications and the need for transfusions in obese and overweight patients undergoing transfemoral percutaneous coronary intervention (PCI), but the benefit over manual closure was not seen in lean and normal-weight patients or in those treated with a glycoprotein IIb/IIIa inhibitor, researchers reported.

The benefit was also counterbalanced by a small increase in risk of retroperitoneal bleeding, Hitinder S. Gurm, MD, of the University of Michigan Cardiovascular Center in Ann Arbor, and colleagues, wrote online in the Annals of Internal Medicine.

Vascular closure devices (VCDs) are designed to prevent arterial bleeding, especially after PCI performed by the transfemoral route, which is still the most common route in the U.S.

The devices permit closure of the arteriotomy site using sutures, plugs, or metallic clips, but the role of these devices in preventing vascular complications remains controversial, the researchers noted.

"Most randomized trials evaluating VCDs have been small and underpowered, and the largest meta-analysis on the subject raised concerns that these devices may be associated with an increase in vascular complications," they wrote. "These devices are commonly used in clinical practice, and a recent large observational study suggested that they may be associated with a reduction in bleeding complications."

The newly published study is among the first to compare the efficacy of VCDs to manual closure in the real-world PCI practice setting, with the focus on specific subgroups with the highest risk for complications.

Researchers collected data on 92,000 patients who had PCI procedures at 32 Michigan hospitals participating in the Blue Cross Blue Shield of Michigan Cardiovascular Consortium (BMC2) between 2007 and 2009.

Of the 85,048 PCIs that met study inclusion criteria, 28,528 (37%) used VCDs.

A main study endpoint was vascular complications, including acute thrombosis, loss of limb, retroperitoneal bleeding, need for surgical repair, pseudoaneurysm, or hematoma requiring transfusion or arteriovenous fistula. Other endpoints included transfusion or in-hospital death.

Using propensity score-matched analysis, the use of VCDs was found to be associated with reductions in vascular complications (OR 0.78, 95% CI 0.67-0.90, P=0.001) and post-procedure transfusions (OR 0.85 CI 0.74-0.96, P=0.011).

"These findings were consistent across many prespecified subgroups except for patients with a BMI less than 25 kg/m2 and those treated with platelet glycoprotein IIb/IIIa inhibitors, in whom the benefit of VCDs over manual closure was attenuated," the researchers wrote.

When specific subtypes of vascular complications were evaluated, VCDs were associated with fewer hematomas (OR 0.69 CI 0.58-0.83, P<0 .001="" 0.38-0.76="" 0.54="" 1.12-2.20="" 1.57="" also="" an="" associated="" bleeding="" but="" ci="" in="" increase="" odds="" of="" or="" p="0.009).</span" pseudoaneurysms="" retroperitoneal="" the="" they="" were="" with="">

"Our sudy supports the conclusion that VCDs are associated with reduced vascular complications and transfusions," Gurm and colleagues wrote, adding that the benefit of these devices was evident only in obese and overweight patients in whom manual control of access site is usually difficult.

The study also confirmed that VCD use is particularly beneficial in patients treated with bivalirudin and that its use was associated with a significantly increased risk for retroperitoneal bleeding, which negated any benefit in patients who received GP IIb/IIIa.

"Our data suggest that physicians contemplating VCD use should carefully weigh this increased risk for retroperitoneal bleeding against the expected reduction in pseudoaneurysms and hematomas," the researchers wrote. "The decision to use these devices needs to be individualized for each patient."

BioCer Launch of HaemoCer Plus versus Arista, Perclot and unknown other as presented at EACTS in Vienna

Clearly demonstrated without question German technology continues to impress as "THE" device developer in the powdered plant based starch market. In the video you see from left to right Arista, Perclot, Unknown and the radical new polysaccharide agent HaemoCer Plus.

Woman's face catches on fire during surgery

A woman's face caught on fire during routine surgery in the US.
Kim Grice, 29, was undergoing surgery to have cysts removed from her brain when her face erupted in flames.
Grice was airlifted to a Burn Unit with burns to her face and neck.
Grice's father, Ted Grice, told a local newspaper his daughter's face had "caught on fire" during surgery.
"The doctors and the hospital are not telling us what happened," he said. "They said they had never seen anything like it before and they are terribly sorry that it happened."
Grice's mother said she was in shock.
"This is not what happens with a routine outpatient surgery."
According to ABC News, however, "flash fires"are not uncommon.
Between 550 and 650 surgical fires occur each year in the US alone. More than half of surgical fires happen inside a patient's airway or on the patient's upper body, while a quarter of surgical fires happen on other parts of the body.
About 70 per cent of "flash fires" are ignited by electrosurgical tools commonly known as Bovies, devices that use a high-frequency electric current to cut tissue or stop bleeding, reported MSNBC.
Twenty per cent of fires are sparked by hot wires, light sources, burrs or defibrillators while about 10 per cent are sparked by lasers.

BioCer Release Test Data on "PURE"-ity of Latest Hemostat Innovation HaemoCer Vs. Perclot

A year ago Cryolife CEO Steve Anderson was embroiled in the meltdown of the CRY/Medafor relationship as the distribution agreement for first generation polysaccharide hemostat Arista came to a very bitter and public disintergration.......more HERE. Following this debacle CRY have entered into an agreement with merchant Starch Medical a San Diego based company with manufacturing facilities for Perclot (generation 2 of the polysaccharide powders) based in Beijing, China.http://www.docstoc.com/docs/60831472/PerClot-Arista Our 2009 Poll indicates concern, results HERE.

Now it's Q2 one year later and newly released test reports commissioned by German based BioCer, manufacturers of HaemoCer (conducted by a third party laboratory) offer compelling information supporting the contention their PURE (Polysaccharide Ultra-Hydrophilic Resorbable Engineering) process is much more than marketing hype. The report comparing CRY's Chinese Perclot with German made HaemoCer is available HERE or by clicking the thumbnail below.

Meanwhile video of HaemoCer shows the latest polysaccharide plant based hemostats formation of a powerful adhesive gelled matrix in comparison to generation 1 product Arista by Medafor Inc.

Perclot Vs. Haemocer

Small wonder! 

Unethical Device Sales Activities Exposed - Corporate Goals 1, Patient Safety 0

The healthcare giant was charged by the US Securities and Exchange Commission with violating the Foreign Corrupt Practices Act by bribing public doctors in several European countries - and paying kickbacks to Iraq - to illegally obtain business. The FCPA forbids US companies from bribing foreign government officials (read here).

Specifically, various Johnson & Johnson (JNJ) units paid bribes to public doctors in Greece who chose J&J surgical implants; public doctors and hospital administrators in Poland who awarded contracts to J&J, and public doctors in Romania to prescribe J&J meds. The subsidiaries - including DePuy and Janssen Pharmaceutica - also paid kickbacks to Iraq to obtain 19 contracts under the United Nations Oil for Food Program, according to the SEC complaint (pdf).

To settle charges, J&J agreed to pay $48.6 million in disgorgement and prejudgment interest, and another $21.4 to settle parallel criminal charges that were announced by the US Department of Justice. Meanwhile, J&J is also paying $8 million to resolve an investigation by the United Kingdom Serious Fraud Office into its DePuy unit (see this).

Why did the docs agree? The doctors and administrators working for public entities in Greece, Poland, and Romania, who ordered or prescribed J&J products, were rewarded with cash and inappropriate travel, among other goodies. And J&J subsidiaries, employees and agents used slush funds, sham civil contracts with doctors, and off-shore companies in the Isle of Man to carry out the bribery.

The charges are not a huge surprise, however. Last summer, the feds announced they have begun paying closer attention to interactions between the pharmaceutical industry and foreign governments (background). And several months ago, at least five big drugmakers received letters as the federal government seeks to uncover any violations of the FCPA.

Four years ago, by the way, the healthcare giant made a “voluntary disclosure” to US authorities about improper payments, which were made by unspecified foreign subsidiaries in connection with the sale of medical devices in a pair of unnamed countries. And the worldwide chairman of medical devices and diagnostics retired (read this). In this disclosure, the SEC noted that J&J also conducted an internal probe, according to an SEC statement.

"The Justice Department “will be intensely focused on rooting out foreign bribery in your industry. That will mean investigation and, if warranted, prosecution of corporations, to be sure, but also it will involve investigation and prosecution of senior executives,” Breuer told the crowd, adding that individuals will be held accountable, according to The Legal Times.

“I don’t care if you’re a physician and I don’t care if you’re the clerical worker. It has to do with what you do. But if you do it, your MD degree is not going to be a shield,” Breuer said. Overall, he said, the Justice Department is pursuing more than 120 FCPA investigations in cooperation with the FBI and the Securities and Exchange Commission.

And Tony West, an assistant attorney general and chief of the department’s Civil Division, noted that he recently told the Senate Judiciary Committee that enforcement will not be limited to companies."

BioCer Introduce Latest Plant-based Hemostasis and Coated Hernia Repair Technologies to China

BAYREUTH, Germany, March 21, 2011 /PRNewswire/ -- BioCer Entwicklungs GmbH, a Bayreuth, Germanybased medical device manufacturer, are pleased to announce their attendance at the China Medical Equipment Fair (CMEF) Shenzhen, China 15th-19th April 2011. HaemoCer(TM) an Absorbable Polysaccharide Hemostat (APH) and Ti0(2)Mesh(TM) Hernia repair system will be on exhibit at the BioCer booth.

HaemoCer(TM) APH technology is delivered in a powder format developed to meet the challenges of problematic bleeding in surgery. Utilizing Biocer's Polysacharide Ultra-hydrophilic Resorbable Engineering (PURE) process modifies plant-based polymers to create a highly absorptive, biocompatible agent which enhances and accelerates the natural clotting cascade. The PURE technology format of HaemoCer(TM) APH contains no thrombin, collagen, or other human or animal components, and is resorbed within days.

TiO(2)Mesh(TM) is an implant utilizing a biocompatible coating for surgical Hernia repair. Ti0(2)Mesh(TM) combines multiple requirements, specifically addressing the needs of the laparoscopic surgeon. TiO(2)Mesh(TM) offers a complete solution to the laparoscopic surgeon and coincides with the advance and rapid growth of minimally invasive surgery in China.

Heinz-Josef Schmies, Managing Director of BioCer Entwicklungs Gmbh commented, "The introduction at the CMEF of HaemoCer(TM) APH and its proprietary, integrated PURE technology offers Asian-Pacific medical professionals an opportunity to examine directly the latest advance in polysaccharide hemostats. TiO(2)Mesh(TM) which encompasses a cutting edge coating technology combined with all the requirements of the ideal Hernia repair mesh offers a complete solution to unmet needs. We anticipate surgeons and patients in China and Asia-Pacific will benefit from these advanced technological innovations in Hernia repair and Hemostasis."

BioCer Entwicklungs GmbH is a privately-held medical device company and welcomes CMEF visitors to their booth H26, hall 2. For further information, distribution inquiries, and licensing options, please visithttp://www.biocer-gmbh.de/en/.

German Plant-based Hemostatic Innovation HaemoCer Receives CE Approval

BAYREUTH;Germany, December 16, 2010 /PRNewswire/ -- BioCer Entwicklungs GmbH, a Bayreuth, Germany-based medical device manufacturer, are pleased to announce the CE approval of HaemoCer(TM), an Absorbable Polysaccharide Hemostat (APH). Introduction of HaemoCer(TM) APH will commence this month in the European Union and other selected international markets.

HaemoCer(TM) is an absorbable, surgical hemostatic technology created via a Polysacharide Ultra-hydrophilic Resorbable Engineering (PURE) process. PURE processing utilizes sophisticated, plant-based polymer crosslinking that creates ultra-hydrophilic, biocompatible, polysaccharide compounds. The PURE technology format of HaemoCer(TM) is a powder; alternate novel product formats are planned for release Q2 2011. A family of customized, single-use application instruments will enhance the delivery of HaemoCer(TM) particles to the wound site for the control of capillary, venous and arteriolar bleeding in both open and minimally invasive surgical procedures. There is no thrombin, collagen, or other human or animal components in HaemoCer(TM) particles.

Heinz-Josef Schmies, Managing Director of BioCer Entwicklungs Gmbh commented, "In conjunction with clinical trial results due Q1 2011, the introduction of HaemoCer(TM) APH and its proprietary, integrated PURE technology represents the next generation of polysaccharide hemostatic agents. Complete production of HaemoCer(TM) is conducted in Germany and has been warmly received by multi-disciplinary surgical specialists. Our technology has been favorably received in multiple international markets and fields."

BioCer Entwicklungs GmbH is a privately held medical device company and develops novel materials and uses them to create new or modified medical devices and manufacturing technologies. BioCer Entwicklungs current solutions incorporate ceramic, polysaccharide, polymer and other composite materials developed with leading Bavarian scientific expertise in collaboration the University of Bayreuth. The proprietary, patent-pending technology platform for HaemoCer(TM) and PURE processing will focus on the worldwide, hemostasis, wound care, hernia repair and orthopedic marketplaces. For information, distribution inquiries, and licensing options, visit http://www.biocer-gmbh.de/en/ Contact:info@biocer-gmbh.de

Kraig Biocraft Laboratories Announces Application for Trademark of Spider Silk ...

LANSING, MI, Oct 05, 2010 (MARKETWIRE via COMTEX) -- Kraig Biocraft Laboratories, Inc.(KBLB 0.15, +0.03, +22.92%) announced today that that it has filed intent to use applications with the US Patent and Trademark office seeking registration of numerous marks for the purpose of branding recombinant silk fibers.
"The Company views branding of our recombinant silk to be just as important as it is with any other product line. It is anticipated that the proposed marks will enhance product marketability and distinguish our advanced technology from other fibers in the marketplace," said Kim Thompson, the Company's CEO and founder. "This is just the beginning of the Company's efforts to further distinguish itself in the market place as we move toward the commercialization of our technology."
The intent to use applications included seven separate proposed marks including Spiderpillar(TM) and Monster Silk(TM).
The Company recently announced the successful development of recombinant spider silk based fibers using genetic engineering. 
The Company will also hold a shareholder press conference on Friday, October 8, 2010 at 4:30 p.m. EDT and will issue a reminder press release the morning of the conference call, which will include the phone number and access code instructions.

Reporting Adverse Events to MedWatch

Chinese hospital compensates patients hurt by fake Roche drug 

Eight arrested in China over fake rabies vaccines 

Avastin officially hits Chinese market after fake drug incident

Austrian authorities destroy more than 22000 fake medications sold online

Air/Gas Embolisms with Pressurized Spray Devices for Hemostasis

EU Lacks Transparency In Adverse Event Reports

The regulatory considerations for the US are often cited as so rigorous that they delay valued technologies reaching the market. However weak EU vigilance and a systemic vision for EUDAMED lacking transparency earmarks all EU individuals as easy victims for massive medical device testing and product failure.
In todays world of outsourcing of Medical Device production to manufacturing wild west territories such as India and China concerns should be creating a greater need for vigilance and freedom of public access. And yet Eudamed state:

Who can access Eudamed?

Eudamed is a secure web-based portal acting as a central repository for information exchange between national competent authorities and the Commission and is not publicly accessible. Eudamed is currently being used by a number of Member States on a voluntary basis and will be obligatory as from May 2011.

However the public are not to be informed, it would seem reasonable for a patient or physician to have available adverse event reports (proven or not). It seems EU citizens will not have this visibility.......WHY???
Fundamentally the EU lacks transparency for both patients and physicians in terms of adverse event reports, it also lacks clearly defined regulation of notified bodies and along with this does not indicate clear packaging notification of origin of country production. A company registered anywhere in the world may not be required to specify their product is produced, packaged and sent from India, China or Timbuktu. 

All of this also begs the question of "What events happen in Mexico, Yemen and beyond?". The case for Global Harmonisation is an issue often discussed but will ultimately be driven by a disaster.

The following Belgian Document (French initially, but English follows) highlights major concerns.

Transfusion may do more harm than good..........

Watch the full episode. See more Need To Know.

"There was...crap in that stuff. This stuff was manky, it was filthy, it was dirty ... but they still stuck it in the arms of children"

Patients have called for the inquiry into how people were given infected blood by the Scottish NHS to have a wider remit, as hundreds of pages of evidence were published.
Campaigners hailed the release yesterday of the preliminary report by Lord Penrose, who is chairing the probe, as a milestone.
It included a list of issues that he will investigate during the next year, among them the use of commercial blood products after it was realised internationally that they carried a risk of Aids and the acceptance of blood donations from prisoners.
Hundreds of people in Scotland were given contaminated blood in the 1970s and 1980s either as treatment for blood clotting disorders or through blood transfusions.
The plight of those who caught HIV or hepatitis C as a result is acknowledged in the opening of the preliminary report.
It says: “It would have been impossible for any person involved in this inquiry to have been unaware of and to have remained untouched by the physical, mental and emotional suffering of the individuals and families affected by these serious and potentially fatal diseases.”
Campaign groups including Haemophilia Scotland said that after years of frustration they were pleased to have such a substantial document.
However, they expressed concern that many of the victims and their families who want to be core participants with legal representation when the inquiry progresses to oral hearings will be disappointed.
About 70 patients and their relatives applied to Lord Penrose to be core participants, but so far it is understood about 14 have been accepted.
In addition, Bruce Norval, who has hepatitis C after receiving contaminated blood, complained the inquiry would not explore other infections – in addition to hepatitis C and HIV – to which haemophiliacs given clotting agents may have been exposed.
He said: “One thing that needs to be highlighted is that haemophiliacs are due a public, truthful account of the full toxic potential of the clotting agents we were treated with from childhood. At the moment, the remit would not fully allow for that.
“What we are trying to get is an understanding why this small group of people, which was 500 strong, are now down to half that number, with more dying on a monthly basis.
“There was all kinds of crap in that stuff. This stuff was manky, it was filthy, it was dirty and they knew it, but they still stuck it in the arms of children.”
The inquiry will examine how patients affected were tested for infections and informed about the results. According to the report, almost two-thirds of patient witnesses said they did not know they were being tested for hepatitis C or HIV and a number describe finding out they had hepatitis C years after tests were carried out.
Lord Penrose has been given accounts of doctors dismissing the illness as “nothing to worry about”, while one witness with HIV said the doctor who told his family was “quite blase”.
The report was released after the inquiry team analysed more than 80,000 documents and took more than 100 statements from patients and relatives.
Solicitor Advocate Patrick McGuire, of Thompsons solicitors, the recognised legal representative of families and sufferers, welcomed the report.
He said: “The document … is clearly very well reasoned and therefore a clear measure of the amount of work that has been put in by Lord Penrose and his team and for that I would personally like to thank him.”
He added that it was subject to consultation and he would be discussing some issues with Lord Penrose.
Lord Penrose said: “It is important to emphasise that I have not reached any conclusions on matters of fact or provided any recommendations at this stage and the list of topics that I have included for further investigation at the public hearings is not definitive.
“I am now inviting comments on these topics from interested individuals and organisations by the end of October.”

What is Recombinant - Molecular Engineering?

Cardiac Catheterization - Closure market threatened as Trans Radial access gains US acceptance

Hats Off! The Best Bleed Video yet!

Congratulations to the team who have created this Hemostasis video............finally a little levity!

Cryolife may have problems beyond continued supply of Hemostase

A new non-clinical video comparing Hemostase (AKA Arista) with PerClot indicates Cryolife may have problems beyond continued supply of Hemostase. The video indicates a much stronger absorptive capacity for PerClot manufactured by SMI. The non-clinical video available HERE on Youtube appears to be an internal SMI validation of their product. Meanwhile the Medafor rejected proposal and (what appears to be imminent divorce) of the Medafor-Cryolife marriage is being thrashed out publicly in a curiously tabloid fashion.

Recently Medafor CEO Gary Shope stated "we no longer believe that CryoLife can be viewed as a trustworthy partner" and on March 18, 2010 after notifying CryoLife that it was treating the EDA as terminated, Medafor notified CryoLife that it would not fulfill their order.

Gary Shope, CEO of Medafor, has also stated, "Over the past six months, CryoLife has repeatedly breached our contract in China, Europe, Brazil and the U.S. CryoLife has also continued to insist that it is entitled to distribute HemoStase in China and Japan, despite the clear terms of the EDA to the contrary . As such, we were highly concerned about whether CryoLife was going to honor our agreement in the future, and had no choice but to insist it provide us assurance, as required by law. CryoLife ignored our request, effectively repudiating the contract and allowing us to cease all performance under the agreement.” Under the agreement, CryoLife had the exclusive right to sell the MPH product into cardiac and vascular surgeries in the United States (excluding Department of Defense facilities) and into cardiac, vascular and general surgeries in the rest of the World (except China and Japan ) excluding ENT, orthopedic, neurosurgery and topical applications.

Both Cryolife and Medafor have made no secret of their mutual dissatisfaction with each other, Cryolife has created a site dedicated to public laundering of their difficulties HERE and includes the following:

Frequently Asked Questions

Why did CryoLife acquire a stake in Medafor? How much of Medafor does CryoLife now own? What were the terms of the proposal CryoLife made most recently to Medafor? What was the breakdown between cash and stock? What has been the reaction of Medafor’s board to the recent CryoLife proposal? Why has CryoLife chosen to make its communications with Medafor’s board public? Is the proposal that CryoLife made to the Medafor board and that it has now withdrawn available to Medafor shareholders? What can Medafor shareholders who wish to sell their shares to CryoLife do? Why did CryoLife purchase additional shares from some investors but not make its proposal available to all? How has Medafor failed to help HemoStase reach its full potential? What will CryoLife do differently? How did CryoLife arrive at its most recent proposed acquisition price? Does CryoLife’s Medafor stake give CryoLife any additional powers outside those of a normal shareholder? Why did CryoLife withdraw its offer? What are CryoLife’s next steps? When does CryoLife plan to communicate with Medafor shareholders? Why did CryoLife file a lawsuit against Medafor? Why is Medafor claiming that CryoLife repudiated its distribution agreement and what is CryoLife’s response? Why would Medafor continually attempt to put revenues at risk and expose itself to additional litigation with this fourth attempt to terminate the agreement? Why would Medafor decline to ship product for additional revenue? Who can shareholders contact if they have questions? While Medafor respond on their website HERE

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 ...."

SMI Presentation Offers Plant Sourced Surgical Bleeding Solution.

SAN JOSE, Calif. - SMI (Starch Medical Inc.) is pleased to announce participation at the European Association of Cardio-Thoracic Surgeons congress (www.eacts.org/) in Vienna, 18-21 October to showcase their advanced PerClot® Chinese manufactured hemostatic products. SMI is currently seeking further representation in select markets within the EU (lang@starchmedical.com), Asia-Pacific and Middle East (phil@starchmedical.com) for PerClot, and welcome enquiries at their EACTS booth number 56.

An SMI Marketing Partners Conference will also be conducted on Sunday, 18 October at 19:00. The Conference will include a clinical review of PerClot® applications and new product developments.

About SMI.

SMI (Starch Medical Inc.) is a San Jose, CA based medical device company engaged in the design, manufacture and sale of innovative, absorbable surgical hemostats synthesized from Absorbable Modified Polymers (AMP™), a proprietary, patent pending technology. SMI has organized a global distribution network for the marketing and sales of PerClot® Polysaccharide Hemostatic System (PHS), which launched in the 4th Quarter, 2008.

About AMP Technology.

Absorbable Modified Polymer (AMP™) technology is a proprietary engineering process that modifies plant starch into ultra-hydrophilic, adhesive forming hemostatic polymers. AMP™ materials are biocompatible, absorbable polysaccharides containing no animal or human components. Utilizing this purified plant source material is critical to minimizing the risks of infection and bleeding-related complications during surgery.
AMP™ particles have a molecular structure that rapidly absorbs water from blood, creating a high concentration of platelets, red blood cells and coagulation proteins at bleeding site, which accelerates the physiologic clotting cascade. The AMP™ blood interaction rapidly produces a gelled matrix that adheres to and forms a mechanical barrier with the bleeding tissue. AMP™ particles are readily dissolved by saline irrigation and are totally absorbed within several days.