By now, most folks have probably read the new series issued by the New York Times, which discusses some serious errors that have been made during radiation therapy treatments for cancer patients. It's an emotional and disturbing read, and one that does justice to the immense importance of standards and quality assurance protocols in the realm of RT.
These articles cast a heavily skeptical eye toward the radiation therapy industry, focusing not just on quality control measures, but also on the pace at which we've seen adoption of new, expensive, and technologically complex RT machines. The point being that these innovative new technologies require increasingly complex quality review due to their reliance on computers and automation to perform much of the treatment planning and delivery functions for each patient.
The lens through which the articles explore these concerns and criticisms is one used to uncover a number of heartwrenching human interest stories. And the gravity of each of these patients' situations intensifies the concerns over radiation therapy safety. However, there are many angles to any one story, some of which don't receive as much focus as others.
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Intuitive Surgical, the maker of da Vinci Surgical System, reported continued 2009 growth in its fourth quarter earnings call last Thursday, January 21.The new da Vinci Si system, which was launched in April, drove much of Intuitive's 2009 sales. In total, 110 dV surgical systems were sold in the last quarter, including 20 old systems which were credited for Si upgrades. Q4 da Vinci sales bring the global total to 1,395, of which 1,028 are in the United States, 248 in Europe, and 119 in other parts of the word.
Clinically speaking, the number of da Vinci procedures performed rose to an estimated 205,000 in 2009, an increase of 51% compared to 2008. The international market, in particular, is expanding at a rapid pace--procedures done outside of the US grew by 60% over 2009. As Intuitive moves forward with its recently granted Shonin clearance in Japan, the company seems poised to move its focus to its international markets as the national landscape becomes increasingly saturated.
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Sales of Mountain View, California-based Conceptus' Essure--recently featured on The Today Show and promoted by Olympic athlete Picabo Street--have grown rapidly over the past three years, reaching an estimated $130 million in fiscal year 2009. During the Essure procedure, a nonsurgical permanent birth-control product, physicians place coiled micro-inserts into the fallopian tubes; within three months, the body and micro-inserts create a barrier preventing sperm from reaching the egg. This procedure maintains a 99.8 percent efficacy rate and provides an attractive alternative to women hesitant to undergo tubal ligation--a surgical procedure requiring general anesthesia.
According to an article published in Investor's Business Daily, Conceptus plans to target the nearly 7.5 million women in the US who have no plans to expand their families yet currently rely on temporary birth control methods as well as the 500,000 women undergoing tubal ligation annually. However, Conceptus will soon face competition from Bedford, Massachusetts-based Hologic, Inc., which recently received FDA approval for Adiana--a nonsurgical permanent birth control product similar to Essure.
Click here to read the full Investors.com article.
Click here to view the Essure website.
Day two of the STS/AATS Tech-Con began with a standing room-only session focused on hybrid cardiac programs. It's been interesting to see the tone change on hybrid programs from the STS audience, focused on surgeons, versus the interventional audience at TCT. At STS, sessions on percutaneous valves and hybrid programs have really been a call to action, signaling from STS leadership a need to progress the future of the specialty.
In the various talks regarding the clinical and operational considerations of hybrid programs, one common theme rang throughout them all--the absolute need for collaboration between cardiac surgeons and interventional cardiologists. This was evident at this conference--which is normally attended by surgeons alone--when several interventional cardiologists were invited to deliver and moderate discussions about hybrid programs. Both hybrid procedures and hybrid rooms could bring these specialists together or be the cause of a further chasm between them. STS leadership is definitely presenting the case to work together with interventional cardiologists, especially in light of the fact that so few cardiac surgeons have endovascular experience.
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Greeting from sunny Florida! I'm currently in Ft. Lauderdale, Florida at the Society of Thoracic Surgeons (STS) and The American Association for Thoracic Surgery (AATS) 2010 conference. We're currently at the STS/AATS Tech-Con, which is full of innovative sessions on the latest advancements in minimally invasive techniques and new technologies.
The Tech-Con began by covering the changing dynamic of the cardiothoracic specialty and how training programs must adapt to develop new cardiothoracic surgeons. The moderator of the session, Dr. Irving Kron from the University of Virginia, finished his introductory remarks with the theme of the session, it is a "Time of Change." With the advent of more cardiac-specific percutaneous therapies on the horizon and the continued dwindling of both CT surgery volumes and resident applicants, the leadership of STS continues to push its membership to move towards a new paradigm of cardiothoracic surgery.
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My colleague Allison Shimooka just listed a great posting on the topic of recent developments in the regulation of genetic testing. With the increasingly important, yet somewhat ill-defined, role of genetic testing in cancer care, this is a particularly interesting commentary:
ASCO recently released updated guidelines for genetic testing. The original recommendations were published in 2003 (you can access them here. These new recommendations reflect new developments over the past seven years.
The updated recommendations focus on determining the role of genetic testing in cancer; more specifically, whether the tests are "professionally mediated and have clinical utility." Over the past several years, there has been a surge of interest in genetic testing, particularly amongst the general population driven in large part by direct-to-consumer advertising and numerous news reports on the topic. In fact, many would argue that interest far surpasses the technology, presenting cancer providers with some tricky situations. Namely, many patients are asking for the service, whether they are candidates or not, and there are a limited number of clinicians with the skills and infrastructure to provide the service. Cancer programs have responded quickly, hiring genetic counselors and setting up high risk clinics.
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Looking back on 2009, it's quite apparent that the medical imaging community - specifically the vendors - were hit hard by the economic recession and credit crunch. While we were able to speculate as to what impact those two factors would have on hospital spending, I recently came across some statistics which seem to validate the impact of reduced available capital on industry revenue.
A recent article in Diagnostic Imaging SCAN (subscription required) estimated that new CT scanner sales resulted in approximately $900 milllion in revenue. While this number seems staggering, it is the first time in many years that revenue from CT sales will fall short of the $1 billion mark.
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OK, the headline is probably a bit premature, and potentially even far-fetched. But, new technologies currently in development in nanotechnology bench research could one day impact current standards as far reaching as drug-eluting stents. While stents have been incredibly successful at opening arteries and, in the case of drug-eluting stents (DES), delivering medicine to prevent restenosis or regrowth, they are limited to the few millimeters of space in which they have been deployed. A new technology under development by researchers at MIT and Harvard Medical School may rise above this shortcoming.
"Nanoburrs," targeted nanoparticles that can cling to artery walls and deliver drugs like paclitaxel, have proven successful in early controlled laboratory experiments. The particles are covered in protein fragments that stick to proteins which are found in certain types of tissue damage. This binding ability allows them to travel through the bloodstream, identify damaged vascular tissue, and administer drugs appropriately. In initial tests, the researchers injected the particles intravenously into the tail of a rat and tracked them as they moved to the damaged walls of the rat's left carotid artery. Current studies are focused on atherosclerosis (and are still several years away from clinical trials), but the researchers involved see the potential for additional applications such as targeting tumors.
In TI, we're beginning to look at how bench research in fields like nanotechnology, regenerative medicine (like stem cells) and genetic/genomic research will impact future care practices. Be on the lookout for more updates in The Pipeline as we dive into some of these truly futuristic technologies, therapies and diagnostics.