BB&T

Reform of the French healthcare system was placed on a fast track for legislative approval that turned into a six-month marathon of debate punctuated by several street demonstrations.

But by the end of June, Health Minister Roselyne Bachelot won approval of the Hospital-Patients-Health-Regions (HPST; H pital, patients, sant , territoire) law that restructures the country's healthcare system and gives new executive powers to both hospital directors and regional health system directors.

The French parliament split along party lines in approving the final text, assuring victory for President Nicolas Sarkozy's Union for the Presidential Majority with a 174 to 154 vote in the Senate and a comfortable 179 to 117 result in the National Assembly.

More than 10,000 amendments were proposed and debated, with the final law expanding to 135 articles from the original 33 articles proposed by Bachelot.

Yet, despite the sound and the fury, and in spite of being weighted down with an additional 102 amendments, few changes of substance were made to the government's plan for reform.

And to assure that Sarkozy delivered on his provocative promise to bring American-style management to French hospitals with a "super-CEO," in a rare legislative stunt his health minister introduced an amendment at the last possible minute to reassert the decision-making power for hospital directors over internal medical committees, erasing with a single stroke weeks of debate and compromise driven by pressure from the medical community.

This 11th-hour amendment, approved without debate in the final vote, requires hospital directors to merely "discuss" significant decisions with various hospital committees and removes a more restrictive Senate text requiring directors to "seek the opinion" of internal groups, such as medical directors, nurses and patient care committees.

The Senate took up the cause of the medical community that sponsored several street demonstrations during debates, including for the first time in recent memory a participation by the great "Mandarins," the heads of leading French medical institutions.

These demonstrations offered charming moments on national television as prestigious doctors and surgeons were taught the basics of protesting and given practical instruction on what to wear to a demonstration, for their good health.

"This law is not founded on the healthcare needs of the population, it is the only needs of management that have prevailed," said Deputy Marisol Touraine, who led the Socialist Party's opposition throughout the legislative marathon.

She said opposition parties will seek a revocation of the HPST law from the Constitutional Council, though no one expects this maneuver will have any meaningful effect.

"French hospitals today reflect perfectly what can go wrong with French bureaucracy," said Guillaume Sublet, head of Economic Intelligence and Regulatory Affairs with Nextep Consulting & Health Economics in Paris.

"The government made it clear from the beginning that the paralysis, even sclerosis, in decision-making must be the priority," he said, adding that the newly empowered super-CEOs no longer need to reconcile the diverse and often conflicting opinions of a half-dozen committees to move a project forward.

"Now, for good or for ill, the quality of decision-making will depend heavily on the intelligence and competences of the individual hospital directors," Sublet said.

Also receiving new executive powers will be the directors for the restructured Regional Hospital Agencies. The new name of these organizations, Regional Health Authorities, reflects the shift in the government's reform from a hospital-centric model to one focused on a system for patient care that integrates and coordinates service delivery by both public and private clinics across a given area in "territorial hospital communities," as well as coordinating services of diverse state agencies and the statutory health fund.

The four pillars of the HPST law address modernizing health establishments, enhancing access to high quality care, initiating new public health awareness and prevention programs, as well as creating the new health authorities.

Alma IT and Medicsight in collaboration

Medicsight (London), a developer of computer-aided detection (CAD) and image analysis software that assists in the early detection and diagnosis of disease, reported that it has signed a non-exclusive, software license and distribution agreement with Alma IT Systems (Barcelona, Spain), a developer of advanced digital medical imaging tools across Europe and South America.

The agreement will give Medicsight access to Alma's large installed base of radiology customers in key markets.

Medicsight's ColonCAD API 4.0 software will be integrated into Alma's latest Colon viewer, a 3-D visualization workstation which interprets computed tomographic colonography (CTC) image data.

Alma is one of Spain's market leaders in medical imaging technology. It is anticipated that the new product will be offered to both clinicians and PACS customers via the ALMA 3-D workstation and server-based client platforms.

Reimbursement for hyperthermia in Netherlands

BSD Medical (Salt Lake City) said comprehensive reimbursement has been established in the Netherlands covering the use of hyperthermia and radiation therapy to treat both superficial and deep cancerous tumors. BSD is a provider of systems designed to deliver both superficial and deep hyperthermia.

The Dutch Healthcare Authority has released a reimbursement schedule for 2009 that integrates hyperthermia treatment into the radiotherapy general code structure and for the first time authorizes comprehensive reimbursement for both superficial and deep hyperthermia treatment when used in combination with radiotherapy.

The new reimbursement schedule provides a payment of e10.861 (about $15,289) for a series of four superficial hyperthermia treatments and a payment of e15,104 (about $21,262) for a series of five deep hyperthermia treatments.

The new reimbursement covers the treatment of recurrent breast cancer, head and neck cancer, melanoma and cervical cancer.

Explosive growth in Europe for Edwards

Edwards Lifesciences (Irvine, California) has opened a new European headquarters in Nyon, Switzerland, to serve the company's growing Europe, Middle East and Africa (EMEA) operations.

On the edge of Lake Geneva, the new center supports the rapid adoption of catheter-based implantation of heart valves that saw the number of European centers practicing this less-invasive alternative to open heart surgery increased a staggering four-fold in a single year.

Even as the first clinical studies of one-year evidence of safety and effectiveness for transcatheter aortic valve implants (TAVI) were being presented, adoption by cardiac surgeons exploded.

Where Edwards supported 30 medical centers practicing TAVI in April 2008, one year later there were 125 centers using Edwards devices. The number of implants jumped from 160 to 2,250 in the same period.

Patrick Verguet, Edwards' corporate VP for EMEA, said the new headquarters "will help us accommodate our significant regional growth in heart valves and critical care, and allow us to continue benefiting from a favorable business climate."

The company has forecast TAVI sales to double this year over 2008 reaching $100 million.

"People say there is no reward for innovation until you get to the United States, but the rapid acceptance of our products here in Europe shows a different story, and Europe is becoming a bigger piece of the Edwards' pie," CEO Mike Mussallem told BB&T.

Surgeon training in the procedure is a critical step toward greater adoption and the new Nyon center features a state-of-the-art facility where surgeon's serving as proctors teach and coach their peers in wet labs and on simulators for this delicate procedure that is indicated only for patients, typically older than 75, who are denied open-heart surgery due to co-morbidities and fragile health.

The Europe center is also expected to play a pivotal role in the roll out and continuing development of new Edwards technologies that significantly include a transfermoral delivery system for a new valve the Sapien XT.

ConforMIS receives CE mark for iDuo bicompartmental knee

ConforMIS (Burlington, Massachusetts), which develops and commercializes personalized, minimally invasive medical devices for the treatment of osteoarthritis, reported receipt of CE-mark certification for its iDuo bicompartmental knee resurfacing implant and companion iJig instrumentation.

The company said the iDuo is the first and only patient-specific, bicompartmental resurfacing implant on the market. It is designed for patients whose arthritic damage is limited to either the medial or lateral compartment of the knee, in addition to the patellofemoral compartment.

Each iDuo is custom-designed and manufactured from an individual patient's CT scan using ConforMIS' iFit technology, allowing for an entirely personalized fit.

The iDuo resurfaces only the affected areas, preserving more bone than is true in traditional knee replacement surgery. The iDuo also preserves the anterior and posterior cruciate ligaments, which helps to maintain natural knee kinematics.

"The extent of tissue and bone conservation with the iDuo helps patients retain their future surgical options," ConforMIS said in a statement.

"We are pleased to be the first and only company to bring the clinical advantages of our personalized bicompartmental solution to the European market," said Chairman/CEO Dr. Philipp Lang. "Together with our already approved iUni unicompartmental knee resurfacing system, surgeons now have the ability to treat their patients with resurfacing solutions that are far more bone conserving and minimally invasive than a traditional total knee replacement."

The iDuo surgical procedure features patient-specific instrumentation called iJigs that are designed from the same imaging data as the implant. The iJig cutting and placement guides eliminate manual sizing during surgery and provide tactile guidance to precisely place the implant, "significantly reducing the number of bone cuts required for the surgery, simplifying the steps, and increasing the reproducibility of surgical results," the company said.

The first iDuo surgery in Europe was performed by Joachim Grifka, MD, and Franz Xaver K ck, MD, at the department of orthopedics at University Hospital Regensburg (Bad Abbach, Germany) on June 18.

"We are very pleased that, thanks to the iDuo, we are now able to offer our patients an alternative to a total knee replacement," said Grifka, chair of the department of orthopedic medicine at the University of Regensburg.

K ck added, "Due to the fact that the iDuo requires only the damaged parts of the cartilage to be removed, the healthy cartilage and bone tissue can be saved. Only a very small bone resection is required to perform the surgery."

FDA to hold conference in Israel on approval process

The FDA has unveiled plans to hold a three-day seminar for Israeli medical device companies in early September focused on guiding those companies through the FDA approval process.

The conference, titled "The Regulatory Pathway to Medical Device Marketing in the U.S.," will be held in Tel Aviv from Sept. 8-10 and will include the participation of numerous FDA officials as well as Israeli medical device companies and entrepreneurs.

FDA officials speaking at the recent ILSI Biomed Conference in Tel Aviv announced the meeting. Richard Kotz, acting branch chief of the FDA's Office of Surveillance and Biometrics, said, "Last summer, I met with a lot of Israeli medical device firms and it became clear to me that Israel is a major player in the medical device world. Our participation in this year's Biomed Conference [provides] the medical device community in Israel with the beginning knowledge of what is required to get devices through the FDA approval process."

The September seminar is expected to focus on issues of device classification, effectively targeting the correct patients, avoiding common pitfalls of clinical trials and examining the FDA's role in bringing medical devices to market.