For a decade Jim Tobin has been at the helm of Boston Scientific (Natick, Massachusetts). Throughout his tenure, he's faced unique situations and challenges, such as the med-tech industry's meteoric rise following the bursting of the bubble, and Boston Sci's highly controversial commitment of $27 billion to buy Guidant (Indianapolis).

Tobin, who is nearing his 65th birthday, said in late June that he was retiring from the company. The board of directors appointed Ray Elliott, former CEO of orthopedics powerhouse Zimmer Holdings (Warsaw, Indiana), to take the posts of CEO/president of the interventional technologies company, as of mid-July.

"From my point of view I have been here now for 10 years and that's enough," Tobin said during a teleconference to investors and media. "I believe and have always believed that 10 years is sort of a natural limit as to how long a CEO can expect to be effective and I've reached that. Beyond that personally, it's the right thing to do too."

Questions regarding the quick transition, which is poised to happen in about three weeks, prompted speculation on Tobin's health, which he denied was an issue.

"This has actually been in process since last November," Tobin said of his retirement. "I asked that there be as short a period between the announcement and when the transition occurred to minimize the period of time when it would seem as if I was a lame duck in the position. So three weeks is about right, from my point of view."

He added, "This place is like a video game you know, there's something happening practically everyday, the shorter period of time there is someone running it in a lame duck status, the better off everybody's going to be. So that's what it is. There are no health problems or that sort of thing."

Tobin gave Elliott a stamp of approval and added that he was leaving the company in more-than-capable hands.

Elliott, 59, has more than 35 years of experience leading healthcare and consumer products companies. He led Zimmer for 10 years, joining the company as president and later adding the titles of chairman and CEO.

Prior to joining Zimmer, he served as president/CEO of Cybex International (Medway, Massachusetts), a medical rehabilitation and cardiovascular products company.

Elliott began his career in the healthcare industry with American Hospital Supply, now Baxter International (Deerfield, Illinois), where he served for 15 years in sales, marketing, operations, business development and general management positions, leading to his appointment as president of all the Far East divisions, based in Tokyo.

He also has served on a number of boards, including the Advanced Medical Technology Association (AdvaMed; Washington), where he was chair of its orthopedics sector. He was a member of the Boston Scientific board of directors from 2007 until earlier this year. In addition to serving as president/CEO of Boston Sci, he will rejoin the board.

"Included in that is his international experience, which for Boston Scientific is crucial because we're more or less 40% non U.S. and that number is only going to increase as the years go by," Tobin said. "On top of that, [Elliott] has extensive knowledge in the cardiovascular industry which at this point is where at least 80% of our sales are concentrating. So 25 years with two of the world's leading healthcare companies, international experience, broad experience in leadership roles. That adds up to the right guy from in my point of view."

One of Elliott's first priorities will be to help the company tackle the warning letter it received from the FDA back in 2006, which prevents Boston Sci from winning approvals of new products. The company received the letter one day after it emerged victorious in its bid to snag Guidant, beating out industry colossus Johnson & Johnson (New Brunswick, New Jersey).

The FDA cited Boston Sci's management for not properly tracking complaints over certain products, including its wildly popular Taxus stent, as well as Vaxcel catheters, Leveen needle electrodes and the Enteryx device used in surgery to treat acid reflux.

"We must complete the work and satisfy ourselves without a doubt that we are ready to take on and maintain the final actions required to lift the corporate warning letter," Elliott said. "It goes without saying that these actions need to meet the FDA's view of the goal, but in any event that's one problem that needs to go away and stay away."

Elliott added that there were other conditions that Boston Scientific would face and that would create challenges for the company in the future.

"The financial crisis has had some limited impact on us — cash is more scarce and we do have some obligations coming due but not until 2010 and 2011," he said. "As we continue to integrate prior acquisitions, including Guidant, it's tough to take on more complexity and more debt. Our current stock is certainly underappreciated, depressed and less valuable as currency to attract new businesses."

Elliott said that the company needed to look to developing its other businesses beyond drug-eluting stents and cardiac-rhythm management market. "The first order of business for me each day at 7 a.m. is to review sales from around the world and begin the process of asking why or why not," he said.

'Smart card' proposed to track radiation dosages

The International Atomic Energy Agency (IAEA; Vienna, Austria) is proposing the use of a "Smart Card," or equivalent electronic collection system, as part of, or supplement to, an electronic medical record (EMR) that will document the amount of radiation an individual receives over his or her lifetime.

The need for this type of documentation is critical, those at the IAEA say, given the increasing use of ionizing radiation, especially computed tomography (CT), and the highly negative downstream results of frequent, accumulated dosages: ionizing-produced cancers.

Addressing this trend, one likely to grow even more rapidly, the IAEA held a meeting in Vienna in late April to propose the Smart Card method for documenting the accumulation of radiation dosage over an individual's lifetime; this, the organization said at the time, will be followed a report on the proposal in September and a follow-up meeting in January with a range of representatives from the "e-health" community and the various associations involved in the delivery of radiological procedures.

The need to track the accumulated doses of radiation a person is receiving is backed by authoritative concerns about the overall increase in radiological procedures worldwide.

IAEA cited the most recent estimates from the UN Scientific Committee on the Effects of Atomic Radiation (UNSCEAR) that the estimated collective dose to the world's populations from medical diagnostic and dental X-ray examinations is 4 million man Sv a year (man Sv [Sievert] being a unit defining a dose to a population in biological terms). This is the result of an estimated 4 billion diagnostic X-ray exams — overall an increase of more than 17% over the last 10 years in the collective global dose being delivered.

Drilling down into these basic statistics are two factors of special concern: the greater increase of dosages in the developed countries where X-ray machines are more prevalent and their use driven by robust reimbursement; and "defensive" medicine (this latter attracting increasing attention in the U.S.), thus adding to the total doses provided by new scanning procedures and, especially, via CT.

"During the last 100 years, improvements in technology have resulted in dose reductions for radiographic examinations by a factor more than 10-fold," the IAEA says, in a review of the April meeting. But this same reduction is not the case for CT, it says: "Since its introduction in 1972, CT technology has improved substantially, making it possible to obtain better quality CT examinations. However, patterns of use have been continuously changing, with increased utilization, and the percentage contribution of medical radiation dose from CT has continued to increase."

To produce its 3-D views, the average radiation dose of a CT scan is equal to about 500 chest X-rays, according to IAEA, and the precision of CT images is a factor encouraging increasing CT use. But the organization cites a November 2007 report in the New England Journal of Medicine, estimating that up to 50% of all scans done today are not justified medically.

An alternative terminology for the Smart Card is "Smart Access," IEAE says, because its intent is to provide consistency and greater unification of care for the patient "without affecting the diagnostic or clinical purpose."

Swiss HQ supports Edwards' growth in Europe

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 vice president 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 also is expected to play a pivotal role in the rollout and continuing development of new Edwards technologies that include a transfermoral delivery system for a new valve, the Sapien XT.

Study results boost SpineJack

On the heels of convincing clinical evidence for restoration of vertical compression fracture (VCF), Vexim SAS (Toulouse, France) said it would begin a soft release of its novel SpineJack implant, building to a formal European market launch at EuroSpine in Warsaw, Poland, in November.

With distribution deals in place for the major markets of Europe and a series of clinical trials underway, Vexim is the most advanced of three companies introducing a new generation of devices for treatment of VCF that push beyond the pain relief of balloon kyphoplasty with implants that can restore the vertical height of a crushed vertebrae and provide longer-term correction of this debilitating condition.

Medtronic (Minneapolis) holds a lock on the expanding VCF market, estimated at $600 million globally, thanks to the acquisition of Kyphon (Sunnyvale, California), the pioneer in VCF treatment, for $3.9 billion in 2007.

Vexim released the first-year follow-up results for a pilot study of 20 patients last month and said it has enrolled another 100 patients, who received a total of 256 SpineJack implants, in a pan-European study that will measure clinical outcomes at 12 months.

The European study includes eight centers in Germany, France, Spain, Portugal and Turkey where the pilot study was conducted at six centers in France.

Vexim received the CE mark for SpineJack in May 2008, but said it delayed commercial release of the implant until it could gather clinical evidence to support the claim of efficacy for a controlled, morphological restoration of the cortical ring and endplates) while preserving the spinal joint.

"The evidence show we are not only treating the pain, we are treating the fracture," said Vincent Lefauconnier, the company's chief commercial officer. "All of us are after pain relief, which is the first measure of efficacy," he said.

"Our objective has been to develop a more comprehensive approach to treating these pathologies, with full anatomical restoration of the vertebra," Lefauconnier said.

"Kyphon/Medtronic has created a great awareness that VCF is a condition that can be addressed," de la Grange said. "We are grateful for this pioneering work," he said, adding, "We feel SpineJack is taking treatment to the next generation."

SpineJack is a 5 mm, expandable titanium device measuring 25 mm in length that is implanted in a minimally invasive procedure, typically through two skin incisions. Once inserted and expanded to the required height, bone cement is injected into the vertebra in order to fixate the restored structure, "like putting a cast on a broken arm," said Lefauconnier.

Looking to Israel on universal healthcare

Everybody has an opinion on healthcare reform. And as the debate accelerates, international allies have stepped up to offer advice. Specifically, representatives of Israel spoke out last month about how that country's successful universal healthcare system is worth examining for reference, if not as a model.

"If you ask me if Israeli healthcare hook, line and sinker can serve as a model for U.S. healthcare, I'm sorry that my short answer to your question would have to be no," said Bruce Rosen, MD, director of the Smokler Center for Health Policy Research at Myers-JDC-Brookdale Institute (Jerusalem). "There are too many structural and cultural differences. In fact, I don't think any one country's healthcare system as a whole can serve as a model for any other country. On the other hand, looking into the healthcare of other countries can be very helpful particularly at terms of ferment and possible change such as what you're going through right now in the U.S."

Rosen was one of three speakers in a teleconference, "Healthcare in Israel: A Model for the U.S.?" sponsored by The Israel Project (TIP; Jerusalem), an international non-profit organization devoted to educating the world about Israel.

TIP reports that 100% of Israelis have full healthcare coverage. All citizens are required to join one of four healthcare funds but may also elect to purchase other forms of supplementary healthcare. The country's system is based on regulated competition among those four government-funded health plans compared with hundreds in the U.S. In Israel, the government pays for or subsidizes unaffiliated and even competing healthcare funds and medical research initiatives. It's illegal in Israel to turn down any healthcare applicant for any reason. On average, Israel spends about $2,000 per citizen on healthcare financed through taxes, compared to $6,000 in the U.S.

Another huge difference: "Most of our doctors are salaried, so we don't have those perverse fee-for-services incentives," Rosen said.

But one of the biggest efficiencies behind Israel's healthcare system, he said, is that every doctor uses electronic healthcare records.

"The basic philosophy in Israel is that the government ought to take care of financing to ensure access and equity so the nine governmental sectors, most non-profit, ought to take care of most of the healthcare delivery, that ensures responsiveness and choice," Rosen said. "Our government also plays an important regulatory role to make sure that the insurers and hospitals are really offering what's in the best interest of the population. They should do so while containing costs. This leaves a lot of room for innovation on the part of the providers."

Stephen Zuckerman, senior fellow in the Health Policy Center at The Urban Institute (Washington), provided an American perspective on the Israeli system and how some of its attributes could be copied in the U.S.

"One thing that Bruce points out is that the basic philosophy is that the government ought to take care of financing and leave the non-governmental sector to take care of healthcare delivery," Zuckerman said. "In fact, I think that is exactly what the U.S. is going to do."

He added, "Whether or not the financing is going to be sufficient to lead to universal coverage as the Israelis guaranteed remains to be seen, but I think the basic idea that the government is going to have to provide subsidies to low-income populations either through an expansion of our own Medicaid programs or through vouchers or tax credits or other types of subsidies that would be available to purchase private health insurance seems to be a given if we're going to really move forward and expand coverage in the U.S."