Using airplane technology, scientists in France are making an artificial heart smarter by enabling it to assess and respond to a patient’s need. Manufactured by start-up company Carmat, the device is equipped with the same small sensors that measure a plane’s air pressure and altitude, which it uses to detect the heart’s pumping speed and the pressure placed on the organ’s walls. While there is always the chance of rejection with implants, this artificial heart is made of polymer, pig tissue, and other natural materials, which are less likely to cause rejection or clotting. Another potential advantage of the device is its two pumps (just like the real thing) that send blood into the lungs and the body. The implant would first be intended for patients with heart failure or who had suffered a massive heart attack. Human testing could start within the next two years.
Despite the exciting promise of such a device, some experts aren’t crossing their fingers. Previous efforts to replace the human heart proved unsuccessful, and since the device is so expensive (anticipated cost=$192,140), it probably won’t help take the pressure off the donor shortage.
Instead of “pass me the scalpel,” orthopedic surgeons may start asking nurses to type up the address www.vumedi.com. Think of it as a YouTube for orthopedic surgeons. Doctors can watch videos of surgeries or post their own. Manufacturers can also take advantage of Vumedi’s videos to highlight their products. Scottsdale, AZ-based Cayenne Medical Inc. is the first medical device company to do so. It is using VuMedi’s services to demonstrate how its fixation device enables surgeons to reconstruct a torn ACL. As of August 2008, VuMedi reported that 1000 surgeons had joined its Web site.
Kalorama Information just released a report concluding that reusable medical devices save money over the long term, even if they cost more up front. And, the $4 billion market should experience continued growth through 2012. Reusable devices have gone in and out of vogue over the past few decades. At first, low-cost disposables were widely used for their added convenience. But then these devices came under fire in the 1980s after medical waste washed ashore on several beaches. (Even as recently as two months ago, several hundred syringes washed ashore in Avalon, NJ.) But Kalorama’s market research report indicates that the market for reusable medical devices should grow about 13% annually for the next few years. Industry can credit the orthopedic and general surgery segments for the boost—nearly 70% of the sales generated in 2007 came from these areas. The orthopedic sector continues to outpace others, and it is expected to have sole domination of market shares by 2012.
As part of its ongoing series, “The Evidence Gap†The New York Times is calling out the use (or overuse) of 510(k)s in getting devices to market.
The article does raise some interesting points, namely that the short lead time of 510(k)s was meant to be a stop-gap measure when FDA first began regulating devices. Now, however, it is the most popular form FDA receives by a margin of thousands.
However, author Reed Abelson seems to be forwarding a theory of mass conspiracy against patients, to fool them into using medical technology that does not work and could harm the most innocent of consumers.
For example, the author uses radiation delivery through brachytherapy as an example of “experimental†surgery that enables surgeons to get more money. But don’t worry, according to Abelson, there is plenty of blame to go around. The new technology is used at the expense of “the gold standard†of conventional radiation because reimbursement facilities reward hospitals for using the technology. He points out that conventional radiation has 30 years of use, while brachytherapy, which came out in the mid 1990s, logically does not have such venerable evidence.
And while he does explain that brachytherapy enables patients to receive treatment in a much shorter time and recover faster (five days versus six weeks) with fewer complications, he doesn’t make the logical leap that it ultimately saves hospitals money and is more convenient and represents less risk for patients than traditional radiation.
So, according to Abelson, all players involved are to blame. FDA does not properly vet devices put forth by greedy medical device firms, who trick FDA into giving them market approval without having to prove efficacy. Medicare enables this system by rewarding greedy surgeons who embrace the new technologies. Won’t someone please think of the patient?
It’s great to read good news in these uncertain times, especially when it has to do with our medical device industry. The Minneapolis Star Tribune reports today that seven medical device start-ups attracted a healthy dose of venture capital investment, despite a national decline in VC funding. The article reports that Minnesota had its best VC performance in eight years because of the funding that went to device firms. The state attracted $220.8 million in the third quarter, the first time it has done so since 1999, according to the article. Seven medical device firms, led by CVRx Inc. and Cardiac Concepts Inc., captured $130 million, or 59% of overall investment. What it proves is that as long as companies are developing innovative technologies that fill unmet needs, the funding will be there.
One day after Boston Scientific learned that FDA lifted its “corporate warning letter” in its entirety, it received agency approval for a carotid artery stent, which could reduce strokes, the Associated Press reports. It props open the carotid artery, which provides oxygenated blood to the head and neck. It is a less invasive treatment than the standard of care, carotid endarterectomy, a surgical procedure. The product, which has already received a CE Mark from the European Union, will be sold in the United States immediately.
FDA has removed all remaining aspects of the “corporate warning letter” Boston Scientific received in January 2006 that had prevented it from bringing new products to market, CEO James Tobin said in a conference call with analysts. The measure was imposed in reaction to rampant manufacturing violations. Parts of it have been lifted in the past year, but now all of it is gone, reports Bloomberg News. Tobin said the move will allow the firm to introduce stents to treat blockages in the carotid artery and kidney, as well as a balloon catheter for unclogging blood vessels. Its newest heart stent, Taxus Liberte, was approved Oct. 10 after some of the restrictions were lifted.
St. Jude Medical and Edwards Lifesciences both reported third-quarter profits, while Boston Scientific posted a loss for the quarter, thanks to declining stent sales. St. Jude’s profit was up 21% from the same period a year ago, helped by Boston Scientific’s inability to introduce new cardiac rhythm management products due to a “corporate warning letter” from FDA. That has now been lifted, so St. Jude faces tougher competition in the coming quarters. Edwards’ profits were up 13% over the same period a year ago, thanks to strong sales numbers in heart valves, critical care products, and cardiac surgery systems. Meanwhile, Boston Scientific lost $62 million in the third quarter, though that is better than the $272 million loss it took for the same period a year ago. Most of the difference was due to fewer one-time charges. But its stent sales are down 11% from a year ago, as Abbott and Medtronic introduced new drug-eluting stents into the U.S. market in the interim.
FDA has issued a public health notice about complications associated with transvaginal placement of surgical mesh to treat pelvic organ prolapse and stress urinary incontinence. In the past three years, FDA has received over 1000 adverse event reports regarding these applications from nine different manufacturers of surgical mesh. The most frequent complications included erosion through vaginal epithelium, infection, pain, urinary problems, and recurrence of prolapse and/or incontinence. There were also reports of bowel, bladder, and blood vessel perforation during insertion. In some cases, vaginal scarring and mesh erosion led to a significant decrease in patient quality of life due to discomfort and pain, including dyspareunia. FDA has not yet determined whether particular types of patients are at increased risk for these types of complications.
The agency recommends that surgeons be aware of these issues and be specially trained for each mesh placement technique. They should also watch for complications associated with the tools used in transvaginal placement, especially bowel, bladder and blood vessel perforations. And they should tell patients that surgical mesh implants are permanent and can bring complications — and provide them with a copy of product labeling, if possible.
The agency has also posted consumer information documents on surgical mesh for hernias and pelvic organ prolapse/stress urinary incontinence. It has not issued a public health notice on hernia applications because it does not yet have specific recommendations for physicians regarding hernia repair.
The New York Times has written about an experimental device that can perform stomach stapling surgery without any incisions. Satiety Inc. has developed a procedure called Toga, for transoral gastroplasty, in which a stapler is passed down the patient’s throat and staples his or her stomach from the inside. It is part of a trend toward using natural orifices as entry points for surgery, avoiding the need to make any incision at all. Satiety is conducting a trial in hopes of getting FDA approval; the Times article chronicles one of the procedures during the trial. Early indications are that the Toga procedure offers “a drastic reduction in side effects and risk” compared to conventional bariatric procedures.
First, a dilator is pushed down the throat to widen the esophagus. Then a two-foot-long tube containing the stapler is inserted. The patient’s stomach is inflated with carbon dioxide to create more working space. Then the stapler is positioned and the tube is opened. A wire emerges from the stapler to push aside the folds of the stomach, then a vaccum pump draws in the front and back walls of the stomach into the device to be stapled together. The stapler only holds one row of staples, so for each additional row needed, the stapler is withdrawn, rinsed, reloaded, pushed back down the patient’s throat, and repositioned.
