Air/Gas Embolisms with Pressurized Spray Devices for Hemostasis

New F.D.A.: Transparence and Flexibility

WASHINGTON — During the Bush administration, the Food and Drug Administration was mostly a place of black-and-white decisions. Drugs were approved for sale or they were not, and the agency’s staff was expected to publicly support those decisions.
But as Thursday’s landmark decision on the controversial diabetes medicineAvandia makes clear, things have changed under the Obama administration. Certainty, staff unanimity and even the approval status of big-selling medicines are no longer so black and white.
Presented with what seemed to be a choice between keeping Avandia on the market or withdrawing it, the Obama administration decided on an unusual middle path — allowing sales, but with tight restrictions. Even more unusually, the agency admitted that many of its top scientists disagreed, some passionately. Competing memorandums were posted immediately on the agency’s Web site.
And the agency’s three top officials co-wrote a highly unusual explanation of their action in The New England Journal of Medicine.
Some of these changes have been in the works for years, but they have accelerated under the Obama administration, driven by increasingly sophisticated measures of drug safety and growing skepticism about whether the F.D.A. is making the right decisions and making them appropriately.
“I think that F.D.A.’s credibility really depends on being able to explain its decisions well,” said Dr. Joshua Sharfstein, F.D.A.’s principal deputy commissioner. “We can’t expect people to think that F.D.A. has decided, therefore it’s the right answer.”
Some of the changes have been driven by people like Dr. Steven Nissen, a cardiologist at the Cleveland Clinic whose 2007 analysis of Avandia’s heart risks stunned doctors, patients and legislators, who asked why the F.D.A. had not done anything similar. When the agency revealed it had done an almost identical analysis a year earlier and found the same result, the controversy intensified.
“You have these third-party analysts setting the agenda for the agency in ways that never happened before,” said Daniel Carpenter, an F.D.A. historian at Harvard.
For the F.D.A., the Nissen analysis presented major challenges. It demonstrated that the agency no longer had a monopoly on the information needed to make drug and device safety decisions. Data from crucial clinical trials are increasingly being posted on public Web sites. And academics are using sophisticated techniques to test whether popular medicines are safe.
In March, for instance, a team of academics found that a children’s diarrhea vaccine contained harmless but apparently extraneous pieces of pig virus. Blindsided, the F.D.A. had no idea what effect the particles would have. While the agency studied the problem, the commissioner, Dr. Margaret Hamburg, asked its maker to stop selling — a request she had little power to enforce.
Two months later, the agency allowed sales to continue.
Like the vaccine finding, the Nissen analysis flummoxed the agency because the science behind it was controversial. Dr. Nissen combined the results of many clinical trials to suggest that Avandia substantially increased heart risks. Other studies suggested that there were higher risks.
None of these studies met the rigorous standards that the F.D.A. demands when approving new medicines, but they were among the only information available to explore whether popular medicines contribute to common problems like heart attacks.
The agency was torn about how to interpret the studies, a problem it rarely faced until recently. “In the past, we would approve the drug after a couple of efficacy trials and that was it,” Dr. Janet Woodcock, chief of the F.D.A.’s drug center, said in an interview. “We didn’t know too much more about the drug. It was simpler.”
Now, sophisticated analyses present the F.D.A. with a complex picture. “It’s good for public health that we’re learning more, but it creates a more complex environment in which to regulate,” Dr. Woodcock said.
It is an environment in which top agency officials are in some ways at sea. The agency has no systems or standards to follow in deciding which studies deserve their attention or should lead to changes in a drug’s status. And since new tests are being created constantly, creating such a standard would be an ever-evolving process.
Dr. Lynn Goldman, dean of the School of Public Health and Health Services at George Washington University, said the F.D.A. was being forced to become more comfortable with studies done in academic rather than regulatory settings. “They have to get used to a less controlled environment,” Dr. Goldman said.
And the agency’s decision to create a unique distribution program for Avandia is not one it can repeat often or doctors and pharmacists — who must learn a new system for each program — will give up.
“We have to get some standardization,” Dr. Woodcock said, “or we’ll burn out the system.”

ENTrigue sell Gell into ENT - with Hemcon help

SAN ANTONIO, Sept. 23 /PRNewswire/ -- ENTrigue Surgical, Inc. ("ENTrigue"), a San Antonio, Texas-based company that designs, develops, manufactures and distributes medical devices used for Ear, Nose and Throat surgical procedures, announced today the first clinical experience with its Ventera™ sinus dilation systems.  The Company also announced that it will launch its Synaero™ Hemostatic Gel at the American Academy of Otolaryngology Annual Symposium and Exhibition ("AAO Meeting") in Boston, Massachusetts, September 26-29, 2010 attended by ENT surgeons from around the world.
The Ventera™ sinus dilation systems include a single-use balloon delivered by one of several reusable instruments utilizing ENTrigue's proprietary SerpENT® articulating technology and does not require the use of a guide wire or cannula for delivering the balloon into various sinuses.  The initial clinical cases were performed by Dr. Amin Javer, a world renowned rhinologist and Director of the St. Paul's Sinus Center in Vancouver, Canada.  ENTrigue is in an early-launch phase with the Ventera™ systems in Canada and plans to launch the systems to various European markets over the next few months.  The Ventera™ technology is not presently available for sale in the United States.
Dr. Javer remarked, "The Ventera systems offer an elegant and intuitive approach to sinus dilation.  I am excited about the potential these systems offer as minimally invasive tools for managing sinus disease."  
The Company's new Synaero™ product is a hemostatic gel used to control mucosal bleeding related to sinus surgery and was co-developed with HemCon Medical Technologies Inc., a leading global developer and manufacturer of hemorrhage control products headquartered in Portland, Oregon.  The Synaero™ Hemostatic Gel, as well as the Ventera™ sinus dilation balloon and related instruments, will be on display at the ENTrigue booth at the AAO Meeting.  
ENTrigue also announced the addition of John T. Treace to its Board of Directors.  Treace is Sr. Vice President of Global Marketing and US Sales at Wright Medical Technology, Inc. in Arlington, Tennessee, and served as Director of Marketing for Medtronic ENT for several years prior to Wright.  He joins current Board members Fred Dinger, President & CEO; Donald Gonzales, M.D., Chief Medical Officer; Richard Emmitt of The Vertical Group; and Anthony Natale, M.D. of Prism VentureWorks

Focused on Latest Clinical and Diagnostic Advances in Coagulation

BEDFORD, Mass., Sept. 23 /PRNewswire/ -- Instrumentation Laboratory (IL), today announced it will host the 2nd IL Asia Pacific Hemostasis Forum on Wednesday, October 13, 2010 at the Grand Hyatt Nusa Dua, in Bali, Indonesia.  The event will run from 8:00 am to 12:00 pm, local time.  The forum will focus on the latest clinical and diagnostic advances and trends in hemostasis.  All healthcare professionals, practicing in the Asia Pacific region are welcome to attend.  
Professor Karmel Tambunan, MD, PhD, from the Division of Hematology and Medical Oncology at the University of Indonesia, Jakarta will serve as Scientific Chairman of the Forum.  In addition, several prominent experts in the field will present key information and lead discussions during the Forum, including Professor Ismail Elalamy, MD, a Hematologist at the Hopital Tenon, Paris France;  Associate Professor Tatsuya Atsumi, MD, PhD, from the Graduate School of Medicine at Hokkaido University, Sapporo, Japan;  and, Associate Professor Chris Ward, from the Department of Haemotology and Transfusion Medicine at the Royal North Shore Hospital, Sydney, Australia.
Topics will include new approaches and developments in the diagnosis of Heparin-Induced Thrombocytopenia (HIT), as well as new and emerging markers for Antiphospholipid Syndrome (APS) and associated clinical challenges.
"We are so honored to have some of the leading clinicians from around the world sharing their expertise on HIT and APS management and diagnostics," said Santiago Ramos, Regional Manager for North East Asia.  "The Forum will address many of the key issues facing clinicians today and will provide new information to help them deliver the very best patient care."
About HIT
HIT is a severe immune reaction to Heparin that can result in the paradoxical development of a thrombotic event.  One of the most common of all adverse drug effects, due to the sheer volume of patients receiving Heparin therapy (over 12 million patients annually in the US alone), it has a significant impact on anticoagulant management in hospitals worldwide.  If left untreated, patients with HIT may develop serious sequelae, including pulmonary embolism, myocardial infarction, or death.
Registering to Attend
Through October 1st, 2010, individuals can register to attend this Forum, by contacting Carol Lee, at wbj@werfen-china.com

Z-Medica Signs Distribution Agreement With Biomedica

Z-Medica Corporation, a medical device company developing innovative hemostatic agents, today announced that it has signed an exclusive distribution agreement with Biomedica, a leading Central European medical device distributor, for the hospital and Emergency Medical Services (EMS) markets in Austria, Hungary and Switzerland. Biomedica has strong relationships in the fields of cardiology, cardiac surgery, orthopedics and trauma and general surgery, among other specialties.
QuikClot® products received CE Mark from the European Union in November 2009 and the company has been negotiating distribution agreements with a series of best-of-breed medical device distributors such as Biomedica in European markets since then.
“We are very pleased that we have signed this distribution agreement with Biomedica because of their strong relationships, local sales presence and customer support in Austria, Hungary and Switzerland,” said Brian Herrman, Chief Executive Officer, Z-Medica. “Their focus on cardiology, orthopedics and trauma will be key to getting QuikClot into the hands of surgical practitioners and first responders for the first time in this region, so that they and their patients can benefit from QuikClot’s ability to achieve hemostasis safely and rapidly.”
QuikClot is a surgical gauze impregnated with kaolin, an inert mineral with no known contraindications, and can achieve hemostasis in severe bleeding situations in as little as three minutes. QuikClot is widely used throughout several clinical specialties, including cardiology, interventional radiology, critical care, dermatology, emergency medicine, orthopedics and OB/Gyn, and after months of testing against 12 other hemostatic products in the marketplace, the military version of the kaolin gauze (“Combat Gauze”) was chosen as the exclusive product for use by all US Military Forces in 2008. It continues to be the exclusive product used by all USA military forces for first line treatment of bleeding hemorrhage.
“We are very pleased to add QuikClot to our product portfolio,” said Dr. Stefan Marenzi, Managing Director of Biomedica. “We believe that the product will be well-received by our clients across several different specialties.”

St. Jude Says Data Reveals Excellent Sealing Performance Of Angio-Seal

(RTTNews) - Medical devices companySt. Jude Medical, Inc. (STJ: News ) Tuesday said subset data results for the Angio-Seal Evolution Vascular Closure Device Registry reaffirmed the excellent sealing performance of the Angio-Seal Evolution vascular closure device in patients undergoing routine diagnostic and interventional cardiac catheterization procedures.
The Angio-Seal Evolution device is designed to enable physicians to quickly and effectively seal femoral artery punctures made during minimally invasive catheter-based procedures.
The company noted that the results validated the exceptional performance of the device after being successfully deployed in 99.7% of procedures and with hemostasis achieved in 97.8% of these procedures by the device.
This new subset analysis strengthens those findings by demonstrating no significant difference in deployment success or hemostasis for patients with challenging conditions that might negatively impact device performance, such as obesity and scar tissue at the vascular access site, the company added.

Outsourced Big Pharma and Device Industry.......The Wild West of Blood, Yippee-I-aye!

The financial crisis of the past 18 months has put increasing pressure on drug and pharmaceutical companies to look more closely at their return on investment for R&D. This has led them to narrow the range of projects they believe will bring the best returns.
There has also been a change in the way these companies operate. About a third of the compounds they use now originate from outside the company, a figure that was previously close to zero.
"Within a few years, this could be as high as 70%," says Julian Remnant, director of life sciences for Deloitte. "They are finding the best science is coming from external laboratories."
In parallel, there is a huge push to look at the cost base of R&D. Pharma want these costs to be predictable, something that is hard to achieve when the research is carried out internally. Outsourcing, in contrast, can be done at a fixed cost.

Currently, blood products in China are totally divided into 9 categories from the type of product which is less than the developed countries. Besides, only several manufacturers can produce all the types at the same time. In recent years, the size of the market developed with an annual growth rate of 15%-20%. In 2007, the scale of China blood product market broke through 6 billion RMB Yuan mainly because of the annual growth of the human serum albumin market which takes 80% of China blood market. However, the demands of China blood product market can’t be well satisfied all along. An important reason is the short collection of the plasma raw materials caused by the policy factors. Domestic blood product manufacturers are small-scale enterprises basically, which has holdups including funds, technology, raw materials, and so on. Compared to the global blood product market, China has a very small proportion. However with the sustained economic development and the enormous population, China market has tremendous potential. 

Changing processes
Alongside this trend, the pharmaceutical industry is also in a state of flux as it shifts its base from chemical molecule-based products to biological ones, bringing with it different manufacturing techniques, a lot more clinical trials and an increase in costs that an industry already facing pressure to reduce prices is finding hard to sustain.
"There is a huge push to look at the cost base of R&D. Pharma want these costs to be predictable, hard to achieve when research is carried out internally."
This combination has led some companies to look at the option of outsourcing key functions to more cost-effective parts of the world, notably India, Southeast Asia and Latin America.
"The processes for biological trials are a lot more stringent," says Swetha Shantikumar, an analyst with Frost & Sullivan. "A lot more data needs to be gathered, and the costs of this are high in Europe or the USA. Yet there is cheaper manpower and similar facilities in some of the emerging markets."
On top of this, many common drugs will soon be reaching the end of their 20-year patent protection, and companies are hoping to jump in on this and start manufacturing them cheaply, a task that may prove too expensive in western countries. Add to that a desire for cheaper generic drugs and it is clear why some companies have looked to outsourcing.
"Healthcare costs are hitting the roof," says Shantikumar. "They want more generic drugs cheaper, so there is more pressure to outsource."
Patient pools
The governments of China and India are aware of this and are setting up facilities that are compliant to western standards to attract western drug companies, while the government in Brazil is setting up similar infrastructure so it too can get a share of the pie.
"India has the advantage that the gene pool of patients is very similar to the West, so clinical trial results will be similar," says Shantikumar. "This makes the approval process quicker."
The patient profile in some of these countries is wider than in the West, which can be an advantage for clinical trials. For example, China has a massive population and, particularly in rural areas, a lower standard of healthcare. This results in a large number of ill people and thus a ready audience for clinical trials.
It's a process that also benefits the Chinese people as the government is keen to set up more rural hospitals. Setting up combined facilities that can carry out clinical trials and act as local hospitals is seen as a way to let the West partly fund their creation.
"The financial crisis in the West has led to a lot of people heading back to their own countries."
"Western companies want to participate in the growth in healthcare in these markets," says Remnant. "There is also a lot of scientific talent in these markets."
The cost per patient for conducting clinical trials in these countries is significantly less than in the West. It is also seen as a long-term investment to be in growing markets for healthcare. Having facilities in these countries makes it easier for launching and selling products to their markets and in some cases regulations insist that the trials of drugs have to be carried out locally for the drug to be made available.
Developing countries are also able to capitalise on what is becoming known as the brain gain. Over the years, many of their top scientists and medical staff have been lured away from these countries by the higher earning potential of the West. Setting up research laboratories and more medical facilities on home soil is encouraging some to return to their countries.
"They are coming back and bringing knowledge with them," says Shantikumar. "Also, the financial crisis in the West has led to a lot of people heading back to their own countries."
IP and compliance
One big drawback for international companies, notably China, has been IP protection. Counterfeiting of almost every product has been a major problem in many Southeast Asian countries and has put off international companies from investing in these areas. But the situation is improving and the Chinese government in particular is making big strides to tackle this issue.
"The government wants to improve the situation so foreigners will be comfortable in investing," says Shantikumar. "Previously, there were a lot of security issues. The Indian IP system is stronger than China's but both are trying to improve."
"China has a massive population and a lower standard of healthcare. This results in a ready audience for clinical trials."
India has a language advantage over China when it comes to attracting western companies because far more of its population speak English.
A disadvantage for all these emerging outsourcing locations is that physicians are not as familiar with the clinical trial process as they are in the West, but that situation is improving.
"There are also disadvantages because of lax regulations," says Aparna Krishnan, senior research analyst at IHS Global Insight. "If they work with local industry, there is a danger of supplies being contaminated because standards are not adopted. This is the main worry. It makes more sense for them to set up their own facilities so they can maintain standards."
Remnant agrees: "There are quality issues. The level of compliance is not as high as in the West."

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.

Blood Banking & Blood Products Market to Reach US$36 Billion by 2015

San Jose, CA (Vocus) September 7, 2010
The global market for blood banking and blood products is exhibiting a healthy trend. New infections continue to take a toll on the population across the world, fueling the demand for blood banking and blood products. Regulatory, and healthcare bodies across the world are adopting stringent policies relating to blood safety. As an extension to this, manufacturers are working on developing improved, safer, and advanced blood-banking technologies for the collection, processing and delivery of blood products, further adding fuel to market growth.
The US constitutes the largest regional market for blood banking and blood products, as stated by the new market research report on Blood Banking & Blood Products. In the United States, while 2% of the population receives transfusions annually, another 15% undergo transfusion at least once in their lifetime. On an average, around 50-70 million units of blood, and blood components are transfused in developed countries every year. The developed markets are characterized by increased levels of public awareness, sophistication of blood collection technologies, and governmental support. While developed countries bank blood resources to suffice about 80% of their needs, blood supplies in the developing countries just suffice 40% of the requirements.
Increasing population in developing countries such as India and China, puts pressure on demand for blood on the blood bank segment. Governments of these countries are focused on enhancing healthcare delivery, which includes the blood bank segment. Resultantly, Asia-Pacific is projected to emerge as the fastest growing regional market over the analysis period.
Though blood and blood products provided by blood banks are free from viruses, bacteria, and other disease causing microorganisms, safety has become the main issue the world over. Risks involved in blood transfusion have also become a major issue in the blood banks, and blood products industry. Many companies are now visualizing blood decontamination as a step towards blood safety and availability. Though the process does not do away with the traditional blood screening, and donor exclusion programs, it is expected to prevent infected transmission. New processes are being developed to make blood supply safer. Areas such as blood filtration, and pathogen passivation methods are witnessing development. The need for safe, and suitable blood has been the driving force behind the blood banking, and blood products industry.
The global Blood Banking & Blood Products market is dominated by Blood Components and Plasma Products. The market for blood components and plasma products comprise of whole blood & cellular components, and plasma fractions. Equipment, blood tests, and other consumables are forecast to witness a compounded annual growth rate of more than 4.0% during the analysis period.
Leading blood banks profiled in the report include AABB, America’s Blood Centers, American Red Cross, Canadian Blood Services, Japan Red Cross Society, Lifebank Corp., New England Cord Blood Bank Inc., New York Blood Center, National Blood Foundation, among others. Major players profiled in blood bank technology and supplies space include Beckman Coulter Inc., Becton, Dickinson and Company, CSL Behring LLC, Daxor Corp., Fenwal Inc., Haemonetics Corp., Talecris Biotherapeutics, and ThermoGenesis Corp. Key players in plasma fractionation includes Baxter International, Bio Products Laboratory, CSL Ltd., Grifols, Kedrion, Octapharma, Sanquin, and others.
The report titled “Blood Banking & Blood Products: A Global Strategic Business Report” announced by Global Industry Analysts Inc., provides a comprehensive review of the blood banking and blood products market, current market trends, growth drivers, impact of recession on the industry, segment market analysis and potential, new product introductions/innovations, recent industry activity, and focus on major and niche global as well as regional market participants. The study analyzes market data and analytics in terms of value sales for global as well as regional markets including the US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World. Product segments analyzed include Blood Components and Plasma Products (Whole Blood & Cellular Components, and Plasma Fractions), and Whole Blood & Cellular Components.
For more details about this comprehensive market research report, please visit –http://www.strategyr.com/Blood_Banking_and_Blood_Products_Market_Report.asp

HemCon Medical Technologies Will Appeal Patent Judgment

PORTLAND, Ore.--(BUSINESS WIRE)--HemCon Medical Technologies, Inc., announced today that it will appeal a permanent injunction entered by a US District Court in New Hampshire based on a patent held by Marine Polymer Technologies, Inc. The injunction enjoins further manufacture, use and sale of HemCon’s HEMCON® BANDAGE, CHITOFLEX® DRESSINGS, HEMCON® DENTAL DRESSINGS and any other products which are no more than colorably different from those products. HemCon intends to file a motion for an emergency stay of the injunction during the pendency of the appeal."HemCon will urge on appeal that the Marine Polymer patent is not infringed and/or is invalid, and ask the appellate court to overturn or vacate the judgment. We firmly believe that the lower court made the wrong decision and we are hopeful that the Court of Appeals will correct this and find that HemCon’s products do not infringe the patent or that the patent is invalid,” said John W. Morgan, HemCon's President and Chief Executive Officer.
Marine Polymer sued HemCon in 2006, alleging that HemCon had violated its patent covering a biocompatible chitosan compound. Marine Polymer’s patent describes a chitosan compound that is derived from the sterile culturing of marine micro algae.
HemCon uses a chitosan compound to manufacture highly effective bandages that have been used in battlefield conditions by the U.S. military, among others. HemCon does not use chitosan that is derived from sterile culturing of micro algae, as described in the Marine Polymer patent.
HemCon has separately initiated a proceeding to reexamine the validity of the patent through the US Patent & Trademark Office. In 2009, HemCon filed a request with the Patent Office to reexamine, and possibly invalidate or limit, Marine Polymer’s patent in light of prior publications about chitosan. The Patent Office granted the Request for Reexamination in November 2009. On April 1, 2010, the Patent Office issued a first office action, rejecting all claims of Marine Polymer’s patent. Marine Polymer has filed a response canceling some patent claims and arguing that the remaining claims are valid as originally issued.