BB&T Executive Editor and Staff Reports

Health and Human Services Secretary Mike Leavitt said the first FDA staff would be sent to China, India, Europe and Latin America before the end of 2008, according to a recent Associated Press report.

Saying "we're making steady progress to better safeguard our supply of food and medicines, though much work remains," Leavitt added, "In the past year, we've upgraded labs and equipment, hired additional staff, and begun implementing product safety agreements with key trading partners, including China."

He noted, "Increasing our presence overseas will provide greater protections to American consumers at home and benefit our host countries as well. Opening these offices will mark a key milestone in the globalization of our efforts to enhance the safety of imported food and medical products."

FDA Commissioner Andrew von Eschenbach said, "The globalization of the food supply and medical product manufacturing has demanded that we do things differently. Through our Beyond our Borders initiative, we won't have to send our experts to another country to work with foreign governments and regulated industry to improve our oversight — we'll have staff living there and working on the ground 365 days a year."

The AP report noted that the first overseas office would be in China, with the U.S. government recently securing formal approval for such an office from the Chinese government.

The first FDA staff will be in place in Beijing this year, with additional staff to be posted to that office in 2009. Staff is also scheduled to be posted in Shanghai and Guangzhou next year. The department said it anticipates having a total of eight U.S. nationals at FDA offices in China.

FDA plans to establish its second overseas office in India, with staff first posting to New Delhi yet this year and at least one additional office to follow in 2009. Plans at present are for 10 U.S. nationals to be posted in India.

The U.S. government is in the process of pursuing India's formal approval for offices in that country.

In both nations, FDA staff is expected to work closely with local authorities as well as industries that ship food and medical products to the U.S. to improve safety efforts. Their activities will include providing technical advice, conducting additional inspections, and working with government agencies and private-sector entities interested in developing certification programs.

FDA also will be opening offices in Europe and Latin America before the end of 2008, with a fifth office in the Middle East to follow soon in early to mid-2009.

New UK agreement for med-tech trials

The development of new medical technologies such as hip and knee replacements, pacemakers and coronary stents get a boost in the UK last month, as a new agreement was reported that makes it easier to get approved trials in patients under way.

Launched jointly by the UK Department of Health and the Association of the British Healthcare Industries (ABHI), the model Clinical Investigation Agreement (mCIA) was welcomed by the medical technology industry as timely and helpful.

The mCIA covers all medical technology trials involving patients in National Health Service (NHS) hospitals that are funded by industry.

According to the Department of Health, "it removes much of the previous bureaucracy, which was a significant barrier to the efficient start-up of such trials in the UK."

Previously it was necessary for site-by-site reviews and local legal agreements to be drawn up before industry-sponsored trials could begin. The announcement of the new accord said the mCIA meets the UK government's requirements for transparency about research involving NHS patients, "and ensures that all medical technology industry-sponsored clinical trials are registered and published."

Experience with use of the new agreement will be reviewed after one year.

The agreement is "closely aligned," the Department of Health said, with the revised model Clinical Trial Agreement (mCTA) for pharmaceutical and biopharmaceutical industry-sponsored research in NHS hospitals that was published in 2006, and the Tripartite clinical trial agreement for pharmaceutical and biopharmaceutical industry-sponsored research in NHS hospitals, managed by contract research organizations (CRO-mCTA) published last year.

Peter Ellingworth, chief executive of ABHI, said the association "welcomes the launch of the model Clinical Investigation Agreement which has been the result of a great deal of work by the Department of Health, the medical devices industry and NHS stakeholders. The new agreement for both regulatory and post-market medical device studies will fulfill the need for a document that has the confidence of all parties in order to streamline the administrative process of getting approval for clinical investigations underway at NHS sites."

He added that the agreement "should ... help with the goal of making the UK a world-class environment in which to conduct clinical research on innovative medical technologies."

Public Health Minister Dawn Primarolo said, "The model Clinical Investigation Agreement is the first time that all UK health departments, the NHS and representatives from industry have agreed [to] standard contract requirements for medical technology industry-funded clinical trials."

She added that the mCIA was developed "to enhance the UK clinical research environment for the benefit of NHS patients."

John Jeans, industry co-chair of the Ministerial Medical Technology Strategy Group, said the group "fully supports the principle of the model Clinical Investigation Agreement for medical device companies carrying out clinical investigations in collaboration with the NHS. This document should serve as another step [toward] enhancing the UK environment for medical device research and development."

UK tabs angioplasty as 1st heart attack treatment

The National Infarct Angioplasty Project (NIAP) final report issued by the UK Department of Health says that primary angioplasty is set to become England's first line of treatment for heart attacks, potentially saving hundreds of lives each year.

The NIAP study has concluded that is both feasible and cost-effective to offer angioplasty as an emergency treatment for 97% of the population.

Currently, thrombolysis, the injection of clot-busting drugs, is the most common treatment for heart attack patients in the UK.

The Department of Health said angioplasty is "widely believed to provide superior outcomes, provided that it can be delivered quickly."

According to the NIAP report, clinical evidence shows that using angioplasty as the main treatment for heart attack patients will:

• Save around 240 more lives a year.

• Reduce complications from treatment of heart attack.

• Reduce reoccurrence of heart attack.

• Prevent around 260 strokes a year.

• Decrease the length of stay in hospital for primary angioplasty patients.

The report estimates that 97% of people in England can receive the treatment within acceptable treatment times (120 minutes from call for professional help to delivery of the angioplasty treatment).

Thrombolysis will still be used to treat the 3% or so of patients who would most likely miss the 120-minute window, or who for health reasons couldn't have an angioplasty.

NIAP is an observational study set up by the Department of Health in collaboration with the British Cardiovascular Society and British Cardiovascular Intervention Society.

1st implantation in Japan for DuraHeart LVAS

Terumo Heart (Ann Arbor, Michigan) said the first DuraHeart Left Ventricular Assist System (LVAS) was implanted last month at the University of Tokyo Hospital.

Its parent company, Terumo Corp., said it would continue its efforts toward an early application for approval for manufacture and sales in Japan.

Terumo's LVAS is a third-generation LVAS combining a centrifugal pump with a magnetically levitated impeller. The product received the CE mark in Europe in 2007 and began its U.S. pivotal trial in July.

The Mag-Lev centrifugal pump technology was developed by Dr. Akamatsu, former professor of the faculty of engineering at Kyoto University (Kyoto, Japan), in collaboration with NTN.

The development base was moved to the U.S. in 2000 to continue product development and commercialization efforts.

Accord reached on cancer research

InteRNA Technologies (Bilthoven, the Netherlands) and VU University Medical Center (VUmc; Amsterdam, the Netherlands) reported the signing of a framework research agreement to develop microRNA (miRNA)-based diagnostics and therapeutics for cancer using InteRNA's proprietary library of miRNAs.

InteRNA will apply its lentiviral-based miRNA overexpression library in multi-parametric, high-throughput screening assays to identify the biological role of individual miRNAs and therapeutic targets in leukemia, colon, prostate, and head and neck cancer.

In addition, diagnostic miRNA profiles will be developed through next-generation sequencing, in combination with InteRNA's small RNA bioinformatics pipeline, miR-Intess, on diverse patient sample sets provided by VUmc.

Cardiak plans sale of cardiac business

Cardiak (Oxford, UK), a company that has developed and pre-clinically tested a fully implantable heart-assist device, is on the block. Following discussions with its shareholders and advisors, the company's board of directors is now seeking a sale of its assets via a bid process.

The akpulsor heart-assist device has a number of novel features such as low trauma implantation (with favorable risk/benefit profile, the company said); no direct contact with the blood, avoiding the requirement for anticoagulant therapy; and no leads passing through the skin, limiting the risk of infection.

Cardiak originally was a spin-out company from Imperial College London and the Royal Brompton & Harefield NHS Trust.

The board said this sale represents "an excellent opportunity to purchase an innovative technology" comprising:

• An intellectual property portfolio that includes three key patents filed in many key territories covering a novel axial shift impeller pump and its associated use as an extra aortic counterpulsation device.

• A number of prototype implantable extra-aortic counter-pulsation devices, power supplies and driver systems which have demonstrated excellent hemodynamic performance in direct comparison with the current performance standard for counter-pulsation; the intra-aortic balloon pump.

• Technical details and specifications relating to the akpulsor device and the driver technology

• Cardiak brand image, Internet domains and trademarks.

The board said the assets "would be well-suited to integration into a company seeking a complementary/line extension product to an existing range of cardiovascular devices or looking to access the Class III heart failure market."

Progress on two fronts in NHS

The UK Department of Health reports that National Health Service (NHS) staff in England is making "excellent progress" in two key priority areas – to reduce waiting times to 18 weeks and cut Clostridium difficile infections.

Department of Health statistics for August show that nationally the NHS has met its commitment to ensure that 90% of patients who require admission to a hospital and 95% of patients not needing admission, start treatment within 18 weeks of referral from their general practitioner. This means that the operational standard has been met five months ahead of the year-end 2008 deadline, the department said.

The median referral to treatment time waited by patients who were admitted for treatment has come down from 18.8 weeks in March 2007 to eight weeks in August this year and the median referral to treatment time waited by non-admitted patients has fallen from 7.4 weeks in August 2007 to 4.3 weeks in August 2008. And the number of patients waiting longer than six weeks for a diagnostic test has decreased by 97% since April 2006.

In addition, the latest Health Protection Agency quarterly figures – covering the periodfrom April to June 2008 — on C. difficile infections show a big drop in the key over-65 age group, in which cases have dropped by 18% from the previous quarter and 38% since the same quarter in 2007.

Overall, figures show a 21% decrease on the 2007/08 average and mean that the NHS is well on its way to delivering its target, Health Secretary Alan Johnson said.

Johnson noted, "Twelve years ago it was common for patients to have to wait two years for an operation and in recent years, C. difficile infections were a significant challenge. Achieving our 18-week commitment nationally five months early is great news for patients in England who can now expect much faster access to NHS care."

He added, "It is immensely rewarding to see such a significant reduction in C. difficile following our investment in a comprehensive package of measures to drive down infections."

Self-referrals okayed in the UK

UK Health Secretary Alan Johnson has unveiled a program under which more people should have the freedom to self-refer for services such as physiotherapy and podiatry, which he said will further empower patients and could help cut waiting times.

While some allied health professionals (AHPs) already take on self-referrals, many do not, and Johnson's announcement will give the go-ahead across the profession.

As part of a package of improvements to AHP services, he also noted the intention to collect new data on these areas to support the improvement of services. "We will also introduce quality measures, which will lead to improvements in the overall standard of these services for patients and the public."

Research carried out by the Department of Health in partnership with the Chartered Society of Physiotherapy showed that self-referral to musculoskeletal physiotherapy resulted in patients accessing services more quickly, as well as being more likely to complete their course of treatment and turn up for follow-up appointments.

The research also showed that self-referral resulted in a lower level of work absence for patients and a high level of satisfaction from patients, general practitioners and physiotherapists.

"I am giving the green light to physiotherapists, podiatrists and all AHPs that they can accept patients who self-refer," Johnson said. "Self-referral will help both vulnerable members of society and those with busy lives by providing quicker access without the unnecessary hoop jumping of going to see a doctor first."

bioMérieux opens hub in Middle East

bioMérieux (Marcy L'Etoile, France), a leader in the field of in vitro diagnostics, has reported the opening of a subsidiary in the United Arab Emirates. A hub for its operations in the Middle East, bioMérieux's 39th subsidiary will be based in Dubai.

Active in the region for more than 25 years, bioMérieux said it has established a leading position in the United Arab Emirates diagnostics market through its exclusive distributor, Al Hayat Pharmaceuticals, with which it will continue to work closely.

"This new subsidiary will be the hub for our Middle East commercial team. With 20,000 healthcare professionals in Dubai HealthCare City and international centers of excellence such as Harvard Medical School and Mayo Clinic, there are exciting opportunities in the UAE health economy," said bioMérieux CEO Stéphane Bancel. "[Our] solid business model allows us to continue our international expansion, a key factor for future growth and sales diversification."

Dubai HealthCare City, where the bioMérieux subsidiary is located, has the goal of becoming the leading center in the region, filling a gap in healthcare services in the zone between Europe and Southeast Asia.

bioMérieux said it will bring its expertise as a world leader in diagnostics for healthcare associated infections (HAI) to local hospitals and universities to build HAI management programs.

The Dubai subsidiary also will provide field support to bioMérieux's customers and distributors in the region. Emphasis will be placed on training and a bioMérieux training center is planned, which will provide training on optimal product use and high-level scientific conferences on key pathologies.

bioMérieux provides reagents, instruments and software used for diagnosing infectious diseases and providing what it terms "high medical value results for cardiovascular emergencies and cancer screening and monitoring." It has a presence in more than 150 countries through 39 subsidiaries and a network of distributors.

Regulatory approvals

A sampling of regulatory approvals in Europe reported in the past month:

• St. Jude Medical (SJM; St. Paul, Minnesota) said it has received the CE mark for its SJM Confirm implantable cardiac monitor (ICM), a compact device designed to detect atrial fibrillation (AF) and other abnormal heart rhythms.

Described by the company as being about the size of a computer thumb drive, the SJM Confirm ICM is the smallest implantable cardiac monitor available. It is implanted subcutaneously in the upper chest region and can be implanted in an outpatient procedure under local anesthesia.

The device features a sensing algorithm designed to aid in better signal detection, thus enabling physicians to program the monitor to better sense small and wide-ranging signals. Electrodes on the monitor sense cardiac activity and a continuous loop recorder stores information about the heart's activity.

St. Jude said the electrodes are positioned on opposite sides of the device, which is designed to provide better contact with the subcutaneous tissue for more accurate sensing of cardiac signals.

• InfraScan (Philadelphia), a device firm specializing in brain injury diagnostic products, reported receiving the CE mark for the Infrascanner handheld brain hematoma detector. The company said it plans to launch international sales this fall.

The Infrascanner is a small, completely portable device, which can detect the presence and location of a brain hematoma based on differential NIR light absorption of a hematoma and normal brain tissue.

InfraScan will present the results of a pivotal, 400-patient, multi-center study to the FDA later this year to support its 510(k) application and a subsequent U.S. launch of the device.

It said a pilot study with an earlier Infrascanner prototype involving more than 300 patients demonstrated high sensitivity for detecting bleeding in the brain and for rapidly detecting the onset of delayed hematomas.

• Bovie Medical (Melville, New York) reported receiving the CE mark for its SEER tissue resection device intended for initial use in liver oncology surgery, allowing for the sale of the device in the European Union (EU) and all countries recognizing the CE mark.

The company said it would immediately begin shipping the SEER to customers in the EU through its established network of distributors.