In response to ongoing talks with FDA pertaining to a patient inquiry, Edwards Lifesciences is voluntarily stopping shipments of a heart valve device and removing the product from its Web site. According to Reuters, Senator Charles Grassley released a letter on Wednesday that questioned the use of a version of the company’s Myxo ring. The letter probes whether a surgeon at Northwestern University’s teaching hospital is implanting the device into patients without proper approval. The surgeon in question is apparently the inventor of the device, and a recipient of royalty payments. In a statement, Edwards says that it will be fully responsive to the Senator’s questions.
YouTube ads may earn medical device companies business, but right now, they’re earning a few industry giants bad publicity. Nonprofit organization the Prescription Project filed a petition with the FDA opposing ads for products made by Abbott Laboratories, Medtronic, and Stryker. The group says that the three companies are violating FDA rules by running advertisements without necessary disclosures about usage instructions and warnings related to the devices.
Perhaps incidents like these will push the agency to clear up any confusion that may exist about Internet ads. Prescription Project suggests that the FDA issue a guidance about how agency regulations apply to online device promotions.
The Cleveland Clinic has announced plans to publicly disclose all business relationships that its 1800 doctors and scientists have with drug and device makers, the New York Times reports. The medical center is making its financial ties available on its Web site, www.clevelandclinic.org. In an era with an increasing need for transparency, this seems to be a big step. The center is the first major medical establishment to kiss and tell about potential conflicts of interest. Critics might say that Cleveland Clinic’s disclosure is an effort to make up for past misdeeds—a few years ago, news reports surfaced about improper financial ties of some of its doctors. But currently, less than 25% of the center’s staff has anything at all to disclose.
“We’re trying to be about transparency in everything we do,” says Dr. Delos Cosgrove, a cardiothoracic surgeon and the center’s chief executive.
We’ll have to wait to see whether other major medical centers follow suit.
Medegen announced that it has won its case in the United States Court of Appeals for the Federal Circuit in Washington, DC. The appellate court’s decision reverses a judgment issued by a district court judge in the Central District of California of patent noninfringement entered in favor of ICU Medical Inc.
Medegen argued that the decision inappropriately narrowed the definition of key terms of one of its patents (U.S. Patent No. 5,730,418). The patent covers a number of Medegen’s needleless connectors, including the use of positive displacement technology, which reduces the occurrence of common vascular access device-related complications. The case is now returned to the lower court with the appellate court having interpreted key claim language as Medegen had requested.
The strengthening of the U.S. dollar could spell trouble for exporters of medical devices. It’s already showing in some of the strongest medical device firms. St. Jude Medical cut its fourth-quarter and fiscal 2009 outlook this week, reports CNNmoney.com. Its revenue boost from overseas sales because of a positive foreign-exchange rate is about to even out.
Jeffries and Co. thinks the firm could still have trouble meeting its new guidance. Its analysts believe that SMJ is the weakest of all cardio companies because of its reliance on foreign currency boost.
On a positive note, most analysts have likely already factored in the changing exchange rates. They seem optimistic about the company’s ability to continue to see profits.
Johnson & Johnson (New Brunswick, NJ) is acquiring breast implant manufacturer Mentor Corp. (Santa Barbara, CA). The company’s products will be added to J&J’s Ethicon surgical products unit, and the acquisition is anticipated to close in 2009’s first quarter. It’s interesting that J&J has decided to buy a company rooted in aesthetics during a time when people are limiting spending on nonessentials. However, the companies issued a joint statement, asserting that the deal provides J&J with the “opportunity to strengthen its presence in aesthetic and reconstructive medicine.”
Do you ever wonder how internet-connected medical devices and Bluetooth technology could affect the device market? Or how about how it may affect your interaction with your physician? “Trust Me, I’m Not a Doctor—The Changing Nature of Healthcare,” a new white paper from Nick Hunn of Laird Technologies, argues that such technology is posed to disrupt the balance of power in the doctor-patient relationship. Patients should have the power anyway, right?
This could have a variety of implications for medical OEMs. Hunn compares the evolution of medical technology to that of consumer devices—portable TVs, CD players, and other mobile devices changed the game in those markets. Hunn says that “[medical manufacturers] are still hung up on producing expensive devices designed for clinicians,” and that “they need to start thinking about what happens to the market when the clinician is excluded from it.”
HLB Inc. recently released a compellation of comments from its designers,
engineers, and researchers on the future of medical device.
One prediction is the self-training of medical device. According to the
firm, technologies will mimic those used in the Wii and iPhone. Avatars will
be used to train doctors, surgeons, staff, and patients in the use and
operation of medical devices. Company representatives will also use avatars
to simulate the operation of medical equipment. This will allow doctors and
surgeons to determine if the purchase of a new piece of equipment makes
sense.
Another prediction is that companies will move a “Green” business model that
emphasizes reduction of medical waste. This trend will promote development
of smart technology that can enable sterilization of previously single-use
equipment (syringes, catheters, IV tubes). The business model could further
development of biodegradable body navigation devices.
In addition, the company cited other trends, as follows:
- Movement of medical device from hospital to home.
- Creation of smaller, handheld and protable devices.
- Development of home diagnostics using microelectromechanical safeguards to prevent misuse and inaccurate readings.
- Development of diagnostics that make use of very small fluid samples.
- Increasing use of wireless technology that eliminates the need for expensive cables.
CDRH is scheduled to release a Level 1 draft guidance document on the sex and gender differences in cardiovascular medical device trials reviewed by FDA. Medical Technology Learning Institute will host a workshop on December 9, 2008, in Silver Spring, MD, to explore the history of including women in cardio trials, as well as regulatory considerations, treatment biases, and recruitment challenges.
FDA presents recommendations for the guidance document and rationales behind those reccommendations. The guidance document includes items that may affect medical device companies and others involved in the design and conduct of such studies.
Speakers include Kathleen Uhl, MD, Director, Office of Women’s Health, FDA, as well as various experts from industry, such as speakers from Boston Scientific, Maquet Cardiovascular, Medtronic, CardioMed Device Consultants, Thoratec (invited), and Abbott Vascular.
Researchers at Emory University (Atlanta) have found that the combination of ultrasound waves and drugs work faster to dissolve blood clots in patients with deep vein thrombosis (DVT) than medications alone. Karthikeshwar Kasirajan, MD, assistant professor of surgery at Emory’s School of Medicine, said that using both ultrasound and drug treatment helps to restore flow, prevent valve damage, and could prevent a pulmonary embolism as well. The study involved 37 patients (16 with DVT and 21 with acute in-situ arterial thrombosis) who were treated with a clot-dissolving drug and ultrasound. The technology was used to loosen proteins in the blood clots, which enabled a faster deliver of the drug to the clot. The patients with arterial thrombosis and all but six patients with DVT saw their clots completely dissolve.
