Volcano Corp. has signed an agreement with Siemens Healthcare that allows Siemens to resell Volcano-branded devices. Volcano is best known for its intravascular ultrasound (IVUS) platform, including the s5i IVUS system. The technology allows physicians to examine diseased blood vessels from inside the artery and obtain detailed measurements of vessel and lumen size as well as plaque area and volume. Siemens plans to offer the s5i IVUS system (as well as other Volcano systems and accessories) along with its own Artis brand of x-ray systems.
MD&DI named Volcano Corp. as one of its outstanding OEMs for 2008. There are still a few days left to nominate a company for MD&DI’s Manufacturer of the Year for 2009. Click here to make a submission.
The New Jersey Inventors Hall of Fame has honored Glenbrook Technologies Inc., a 26-year-old x-ray inspection technology company headquartered in Randolph, NJ, with its Invention Advancement Award for 2009.
The award recognizes Glenbrook’s x-ray imaging technology, which produces highly magnified fluoroscopic images that reveal tiny anatomical details, and displays them on a video monitor in full motion, using very low levels of radiation. This capability is not available in any of today’s other radiological imaging modalities.
This technology is now used by most major medical device manufacturers in the United States, for development and production, as well as for preclinical and research studies, to ensure the quality of medical implants.
Glenbrook is only the fifth recipient of the Invention Advancement Award, granted to individuals or organizations in New Jersey that advance inventive, innovative and entrepreneurial activities, making a positive impact on people’s lives. Previous winners were the New Jersey Commission on Science and Technology (1999), the University of Medicine and Dentistry of New Jersey (2000), the New Jersey Technology Council (2001) and the Biotechnology Council of New Jersey (2002).
The New Jersey Inventors Hall of Fame is based at Stevens Institute of Technology. The Invention Advancement Award, and the Hall of Fame’s other awards, will be presented at a dinner held at Stevens Institute on Thursday, Oct. 22, 2009.
As the aging population demographic grows with healthcare costs, there is a need for companies to develop technologies that are more effective and less expensive than drugs. This is especially the case in the field of neurostimulation, which presents a big growth opportunity for device companies. In a study released today by Scientia Advisors (Cambridge, MA and Palo Alto, CA), the firm estimated growth in the neurostimulation market at 16% since 2007. It projects growth rates of 14–23% for certain technologies in this area through 2012. According to Harry Glorikian, managing partner at Scientia, the firm expects that as devices begin to show more safety and efficacy, doctors will recommend implants over drugs (or their use in conjunction with drugs) to their patients. The biggest opportunities in neurostimulation should come through small devices that are more user friendly with longer battery life and better feedback mechanisms, according to the study.
Scientia expects the fastest growth to occur in three key areas:
1. Deep Brain Stimulation. This technology treats 6% of the 6 million U.S. patients who have disorders such as Parkinson’s, tremors, and dystonia. Emerging treatments include epilepsy, depression, and muscular disorders.
2. Spinal Cord Stimulation. This method treats chronic pain. Scientia estimates that when this technology is used with conventional drug therapy, pain is decreased by 50%.
3. Sacral Nerve Stimulation. Scientia cites this technology as a last resort treatment for serious bladder or fecal incontinence. It estimates that 13 million people in the United States have severe incontinence. In the past 12 years, nearly 50,000 patients have been treated with sacral nerve stimulation worldwide.
Yesterday we wrote about Medtronic’s lobbying efforts, but AdvaMed also kept itself busy on Capitol Hill. AdvaMed spent $380,324 in the second quarter of the year lobbying for healthcare reform and other issues. Near the top of the list were issues such as product liability lawsuits, comparative effectiveness, and increased regulation of medical devices made in foreign countries. The group also sought support for its position on a bill designed to update the U.S. patent system (the pharma and medical device segments don’t want patent infringement penalties softened). In addition, AdvaMed spent some time lobbying the Department of Health and Human Services.
Medtronic Inc. spent more than $1 million lobbying Congress in the second quarter, according to a recent disclosure form, reports the Associated Press. The AP says that the company lobbied on the health care reform bills, particularly in comparative effectiveness discussions.
It also lobbied on efforts in the House to make it easier for patients to sue medical device companies via personal injury lawsuits.The medical device industry has argued that overriding the decision would allow state courts to second-guess government medical experts at FDA.
Medtronic lobbyists also advocated their position on a bill aimed at updating the U.S. patent system. The pharmaceutical and medical device industries have argued that reform efforts must not weaken patent protections on medical products by reducing infringement penalties. The reform effort has largely stalled in Congress.
And finally, Medtronic lobbied on legislation that would increase the regulation of medical devices manufactured in foreign countries by charging additional user fees for FDA inspections, according to a form filed July 20 with the House clerk’s office.
Whether they like it or not, bees may play a critical role in fighting cancer. That’s because researchers at Washington University School of Medicine (St. Louis) have found a way to harness bee venom toxin and use it to kill tumors. In high enough concentrations, the toxin, called melittin, can destroy virtually any cell it comes into contact with. Scientists were banking on that kind of power when they attached melittin to nanosized spheres that delivered the toxin to tumor cells in mice. The researchers are calling the spheres nanobees. These drug-delivery devices are continuing to pop up and make us rethink future treatment.
The Associated Press has reported that Daniel Schultz, head of CDRH, is resigning his post. In a letter to agency staffers, Schultz said that he and FDA Commissioner Margaret Hamburg agreed that his resignation “would be in the best interest of the center and the agency,” according to the Associated Press.
Earlier this year, nine scientists wrote a letter to Obama’s transition team that alleged that the device approval process was corrupted. The letter, coupled with growing complaints about the 510(k) process, have led to increased scrutiny of CDRH methods. This month’s Washington Wrap-Up column takes a closer look at Schultz’s role in the 510(k) process.
In a written statement, Stephen J. Ubl, president and CEO of AdvaMed, said about the resignation: “As CDRH director, Dan was instrumental in crafting the historic agreement in 2007 reauthorizing medical device user fees, which has provided FDA’s device program with a stable source of funding to help meet its regulatory responsibilities. In addition, he launched CDRH’s Postmarket Transformation Initiative, which is designed to improve the collection, analysis and utility of the agency’s multiple sources of postmarket medical device data.”
Very interesting perspective on the Medical Device Safety Act (MDSA) from Richard Epstein in Forbes.com this morning. Epstein explains that the unintended consequences of Congress passing such an act, using the Levine v. Wyeth pharmaceutical case as an example. In short, the drug in question in the Levine case, Phenergan is no longer on the market.
Epstein’s speculation is that Wyeth removed the drug (and there are no generic options) because it is unsure how to provide a warning in a way that will protect them from suits after the fact. His conclusion is that if MDSA passes, many medical devices, regardless of thier true medical value, will simply dissappear because device companies won’t be able to fight the slurry of lawsuits that are sure to follow every mishap.
Recent studies published by the CDC and The Journal of Clinical Virology have found that current rapid flu tests aren’t sensitive enough and fail to detect the H1N1 virus more than half of the time. The CDC study found that three rapid tests detect 40% to 69% of H1N1 cases, while the tests were able to detect 80% of seasonal flu cases. It’s important to point out here that these tests don’t specifically detect the swine flu–they simply indicate whether the flu is present. However, there is concern over whether a false negative reading (due to the low sensitivity of the tests) could make doctors decide against prescribing antiflu medications.
The CDC has developed a swine flu test, using instruments manufactured by Life Technologies Inc. (Carlsbad, CA). Although this test can be used in all 50 states to detect the H1N1 virus, it is much more expensive than rapid flu tests. DxNA (St. George, UT) is working on a polymerase chain reaction test that can provide detection of the swine flu within 45 minutes. The company requested that FDA grant an emergency use authorization for the test. DxNA hopes to have it approved for use by the winter.
Details of FDA commissioner’s Margaret Hamburg plan to reinvigorate the agency are not completely clear yet, but Hamburg let industry know what it can expect: stronger, more aggressive enforcement of the rules and regulations that enhance the safety of food, drugs, and medical devices.
“Companies must realize that if they are crossing the line, they will be caught, and if they fail to act, we will,” she said.
Among the new guidelines:
• When FDA inspectors find significant problems at a medical device firm, the company will generally have no more than 15 days to respond.
• FDA warning letters will go out much more quickly with review by its lawyers limited to only significant legal issues.
• FDA will work more closely with local, state and international officials, who often have more authority to take action more quickly than FDA.
• FDA will prioritize enforcement follow-up after warning letters are sent or a product is recalled.
• FDA will no longer issue multiple enforcement letters before taking action.
• Finally, FDA will create a “close-out” process and issue a “close-out letter” indicating violations corrected.
