Medical Device Link The Online Information Source for the Medical Device Industry.

As sexually-transmitted diseases (STDs) are on the rise in the younger population, Chembio Diagnostics is emphasizing the importance of rapid, point-of-care testing. Using its Dual Path Platform technology, the company is developing next generation rapid STD tests. Testing will begin on the products early next year. The rapid tests include an oral fluid HIV test, a screen and confirm point-of-care test for syphilis, and an oral fluid hepatitis C test. According to the Centers for Disease Control, about 19 million new cases of STD infections occur each year and about half of them occur in people between 15 and 24 years of age. Standard syphilis tests can require up to two weeks for results, while a rapid test could reduce the chances of a patient potentially spreading a disease. “Individuals in high-risk groups should be diagnosed at the point of care so as to provide the best chance for behavior modification, other prevention strategies and, where appropriate, treatment,” says Larry Siebert, CEO of Chembio. New technology for diagnosing syphilis allows doctors to start treatment right away. Chembio presented information about one of its new rapid testing products at the 18th Society for Sexually Transmitted Disease Research Congress in London, England.

The issue of one size doesn’t fit all, how this relates to the treatment of patients, and where comparative effectiveness fits in was debated yesterday by panelists during a media event held by Cook Medical in New York City. “There are many who believe in the promise that comparative effectiveness takes us to this promise land of providing treatments that are cost effective,” said Phil Nowell, global leader of Cook Medical’s Aortic Intervention strategic business unit. Although the main goal for Congress and policy makers is deliver data that helps doctors and patients make informed decisions, yesterday’s panel of speakers proved yet again that there are still a lot of unanswered questions surrounding the matter.

“In the financial industry, I think it’s added a new layer of uncertainty for the public and private companies,” said Amit Bhalla, director at Citigroup Investment Research (New York City). “In concept, comparative effectiveness is great—who doesn’t want more data? The question is how it’s going to be implemented: Is it going to be truly clinical effectiveness, or is it going to be cost effectiveness?”

For physicians, the one-size-fits-all approach doesn’t work. Neal Cayne, MD, expressed concern that if only devices that are more cost effective and proven medically effective than others are reimbursed, he could be limited in what devices he can use on patients. “There is clinical judgment when you’re making decision about patients,” said Cayne, the director of the endovascular surgery program at NYU Langone Medical Center. “I’m really concerned that I might not have the best treatment [option] for the patient.” Aside from potentially inhibiting innovation, Cayne’s point is amplified by the fact that comparative effectiveness and the direction of the economy could change the kind of healthcare people receive in the United States. “It’s hard for me to look at a patient with a problem that I know I can fix and the technology is out there, and my hands are tied. It’s very frustrating, and hopefully we can somehow adjust the monetary problem and have the care available for the individual patient that we need. But it’s not going to be easy to do.”

The Senate healthcare bill introduced by Sen. Harry Reid reduced the medical device fee from $38 billion to $20 billion, according to Minnesota Public Radio. You can see how the fees are broken down by downloading The Joint Committee on Taxations’s estimated revenue effects of the bill here.

Minnesota Public Radio says that some politicians believe that the fee is still too high. Minnesota governor Tim Pawlenty and Rep. Erik Paulsen want the fee completely eliminated. As we’ve chronicled on this blog, Minnesota, home to many medical device manufacturers, is just one of the states with leaders that have actively opposed the tax.

UPDATE: Medtronic chairman and CEO Bill Hawkins commented on the revised medical device industry fee proposal today. In a statement on Medtronic’s Web site, Hawkins thanked the Minnesota congressional delegation for minimizing “the negative effects such a tax could have on the medical device industry.”

He also said: “While we are encouraged by this progress, we should not lose sight that this approach will come with a cost to our healthcare system. This tax, though reduced, will invariably impact our investment decisions on new therapy development, jobs, and global competitiveness. Most importantly, this can serve to diminish patient access to new, live-saving medical technologies. While we will work our level best to minimize these impacts, they are real, and they should not be overlooked.”

In a popular episode of ABC’s “Grey’s Anatomy,” Dr. Izzie Stevens cuts her fiancé’s LVAD wire to move him up the heart donor list. It turns out that the LVADs (left ventricular assist devices), which are used to help the heart pump blood until a patient receives a transplant, have the potential to be more than temporary pumps, according to research presented at the American Heart Association’s meeting yesterday in Orlando, FL. One such device doubled the two-year survival rate among heart failure patients. A smaller, quieter, and more durable pump allows patients to avoid having a second major surgery to replace devices that need repair. Plus, researchers are starting to believe that these devices don’t need to be synchronized with the heart. They say that a simple, continuously operated pump offers similar if not better results.

“We had a sense that these smaller devices were going to have better long-term outcomes, and this trial proves it,” Alfred A. Bove, MD, president of the American College of Cardiology, said in an e-mailed statement. He was not involved in the research. “These devices have come a long way in five years. I expect that technology will continue to move things forward and they will be even better five years from now.”

Several medical device firms won Clios (advertising awards) in the inaugural year for healthcare ads.

GE earned two silver Clios with television spots for medical equipment. In one, a doctors uses a travel-sized electrocardiogram in a rural India. In the other, a man falls (literally) for a women when she reads his x-rays in a small Chinese village.

Another silver Clio went to NuvaRing’s ad for a contraceptive vaginal insert. The ad features synchronized swimmers to illustrate repetition of swallowing birth control pills.

The print campaigned for Vibe hearing aids from Siemens also won a silver. The device comes with interchangeable covers in different bright colors and patterns.

A complete list of the winners in the Healthcare Clios can be found here.

After taking into account feedback from payers this year and health reform issues such as comparative effectiveness and economic pressures, ECRI Institute (Plymouth Meeting, PA) has created a list of the top seven technologies that industry should keep its eye on in 2010.

1. Genetic testing. Aggressive marketing has sparked interest in some tests without supporting evidence. In addition, there are gaps in monitoring the quality of the tests.

2. Electronic health and medical records, and personal health records. Clarity related to the roles of these types of electronic records as well as responsibility for verifying patient data, access, and costs need to be established.

3. Premium computed tomography (CT) and ultrahigh field magnetic resonance imaging. Questions have been raised concerning the benefits that each imaging technique offers and when they make a difference.

4. Orthopedic physician preference items. Payers and hospitals are working to figure out how much reimbursement and payment should be made to certain devices, along with whether there is clinical evidence that demonstrates the benefit of one brand over another.

5. Radiation oncology’s competing modalities. ECRI names proton beam therapy, Cyberknife radiosurgery, intensity-modulated radiation therapy, accelerated partial-breast irradiation, and accelerated whole-breast irradiation as modalities to keep watching.

6. Robotic-assisted surgery. There have been undeniable improvements to surgical robots, however payers are taking different approaches to coverage and reimbursement.

7. Therapeutic hypothermia. This technique uses technologies to rapidly cool a patient’s core temperature following a life-threatening situation. Barriers for adoption include a lack of proper equipment in ambulances and a lack of knowledge about the technique.

Sign up for a free download of ECRI’s list, along with an analysis of the technologies here.

FDA Commissioner Margaret Hamburg recently called CDRH “clearly troubled” and said that a formal review of the 510(k) process is underway. At the Reuters Health Summit in New York City, she said that people in the medical industry have voiced concern over the confusion related to 510(k) procedures and that this confusion was also negatively affecting investors. “I was hearing from investors that unless there was a more explicit definition of standards and expectations, that it was increasingly unattractive to them to be investing in the medical device area,” she said. “We are working on some important issues that will benefit industry and benefit the ultimate outcome of our regulatory procedures.”

Hamburg also mentioned that FDA is currently in the process of hiring a new head of CDRH.

Today Covidien is launching a spine sealant in the United States. What’s significant about this sealant, which seals the dural membrane during spine surgeries, is that it’s the first product of its kind approved by FDA. Out of the almost 1.5 million spine procedures performed annually in the United States, about 10% require dural repair and sealing. (The dural membrane is the outermost membrane on the brain and spinal cord.) The sealant is made of a synthetic hydrogel that adheres to tissue and is absorbed by the body.

“DuraSeal is a great example of how we develop solutions at Covidien,” says Michael Tarnoff, MD, Coviden’s chief medical affairs officer in the surgical devices division. “We observe the challenges that surgeons face in the operating room and work with the medical community to come up with innovative products that may optimize patient outcomes, can improve healthcare economics, and are intuitive for surgeons and their teams to use.”

Edwards Lifesciences says that its Edwards Lifesciences Fund will grant $4.6 million in 2009 (more than $14 million since the fund’s inception in 2004). Some of this funding will go toward the University of California, Irvine, to support the development of the Edwards Lifesciences Center for Advanced Cardiovascular Technology.

“Recognizing that the economy has caused many challenges, our fund is awarding more grants for programs that provide basic needs such as food, shelter and clothing this year,” said Michael A. Mussallem, Edwards Lifesciences’ chairman and CEO in a press release. “I’m proud that during these tough times, we have been able to increase both the amount of funding and the number of organizations that receive grants from The Edwards Lifesciences Fund.”

Edwards Lifesciences was recently featured in an MD&DI cover story. Read the article here.

Michael Mussallem, AdvaMed chairman and CEO of Edwards Lifesciences, has accepted that the medical device industry must contribute to the U.S. healthcare reform. According to Reuters, Mussallem said at a health summit: “We’re not huge fans of it, but I think at this point we very much believe that this is something that we need to do that’s our contribution to healthcare reform to help pay for this big bill.”

But the Advamed chairman also says that he hopes the tax will be less than the $40 billion that the Senate is proposing.

Mussallem recently sat down with former president Bill Clinton to discuss the device industry’s role in reform. Read the transcript here.