In the world of women's services, uterine fibroids represent the most common indication for hysterectomy procedures, accounting for 30-50% of all surgeries. These non-malignant tumors can cause abnormal bleeding, pelvic pain, and pain during menstruation. Traditionally, women experiencing symptomatic uterine fibroids undergo a hysterectomy or a surgical resection of these fibroids, known as a myomectomy procedure.
Presently, there is significant training required for traditional myomectomy procedures, which are typically long and uncomfortable for the patient as a large cervical dilation is needed (up to 1 cm). Further, some radiofrequency techniques used to remove fibroids can damage surrounding tissue.
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Johnson & Johnson (Cordis) announced yesterday that it plans to exit the drug-eluting stent (DES) market by retiring its Cypher Sirolimus-eluting coronary stent by the end of 2011. In addition, the company will call off development efforts for its next-generation Nevo Sirolimus-eluting stent.
Though Johnson & Johnson led the market in development of DES 10 years ago, the company has seen continual declining sales and market share over the past several years (36 percent decreased Cypher sales from last year), with simultaneous increased competition from Boston Scientific, Abbott, and Medtronic for the $4 billion worldwide DES market. To compound these difficulties, the company lost access to the Abbott delivery catheters often accompanying the Cypher stent in early 2010. As a result of halted Cypher and Nevo production, two manufacturing plants will be closed in the near future and 1,000 jobs will be eliminated from the Cordis division of the company.
Market dynamics for the increasingly challenging DES terrain will likely be significantly affected by Johnson & Johnson's exit of the business as well; while Cordis brought in $400 million in sales last year--down from their peak worldwide sales of $2.6 billion in 2006--sales for competitor Boston Scientific, who has the highest portion of their sales tied to DES, grew by nearly five percent. Given the already highly developed market for DES, Boston Scientific, Abbott, and Medtronic will continue to research and produce next-generation products in the hopes of obtaining higher prices for these devices and creating additional market share for premium stents.
Despite this setback, Johnson & Johnson notes that it sees greater opportunities to aid patients and expand their business in other areas of the CV device market, and will thus pursue development of other technologies moving forward.
For us here at Technology Insights, one of the highlights of clinical conferences is always the vendor floor. It is here where we get the latest updates on new technologies, including those which may not yet be on the market. Based on our visit to the vendor floor this year, our team noticed two key themes. First, the amount of new therapeutic medical devices and procedures was limited. Besides EnteroMedics' gastric pacemaker, we did not come across many other booths with innovations that could serve as alternative solutions for bariatric surgery. Secondly, software/data tracking companies had a large presence on the vendor floor, more so than at other conferences we have attended, including SAGES. I will discuss these two observations in greater detail in the next paragraphs.
1) Limited medical device innovation
Despite growing demand from the public for bariatric surgery alternatives, the vendor floor did not have many technological innovations that could fill this need. In fact, we noticed that only about 12 of 90 booths (13 percent) were of medical devices. Within this cohort, the one which particularly stood out was EnteroMedics's gastric pacemaker. Whereas most medical device companies (i.e. Allergan, Covidien) brought with them devices which we were already familiar with, including the lap-band and ports for laparoscopic bypass, EnteroMedics presented a technology we had not seen much of before, and that is a pacemaker which induces weight loss by controlling hunger pangs. That said, Technology Insights is not endorsing EnteroMedics.
The point here is that we did not encounter other new devices that could potentially displace the common bariatric surgery procedures of today (gastric bypass, banding, sleeve gastrectomy). From what we could glean, it appears that this dearth in innovation (at least, at ASMBS) is largely a result of stringent FDA standards. Because FDA guidelines dictate that new devices must induce at least 20 percent more weight loss than a control group, many start-up device companies have found it difficult to secure the necessary federal regulatory approvals to market their technologies. Furthermore, it is likely that the recent economic recession has somewhat hurt volumes for elective procedures such as bariatric surgery. In turn, small start-up device companies focused on obesity technologies may have seen a dip in their funding from venture capitalists.
2) Strong presence from media consulting and software/data tracking companies
This year, media consulting and software/data tracking companies comprised 20 percent of the vendor floor. This is a relatively significant composition compared to other conferences we have attended. The strong presence from media and software solution providers is an affirmation of how consumer-driven and data-dependent the bariatric surgery market is. On the one hand, bariatric centers typically need strong consumer-directed marketing and outreach strategies in order to succeed. It is not unusual, therefore, for institutions to partner with third-party media companies for their marketing efforts.
Meanwhile, clinical outcomes for bariatric surgery are critical for not only COE designation, but also reimbursement. This force, combined with the increasing focus on adopting electronic health records, has likely contributed to consistently strong showing of software/data tracking company vendors at ASMBS.
The debate over bariatric surgery for the treatment of type II diabetes continues at this year's ASMBS conference. Notably, since last year, the International Diabetes Federation (IDF) recognized surgery as an acceptable treatment option for type II diabetes in some patients. And, while physicians have documented the anti-diabetic affects of bariatric surgery, they as yet do not know the exact mechanism for diabetes resolution after surgery, and are in the process of determining which weight loss procedure provides the best anti-diabetes outcomes, if significant differences in anti-diabetes effects even exist between the various bariatric surgery types.
Surgeons at ASMBS acknowledge that, while initial anti-diabetes outcomes are promising, robust research is necessary to establish the true efficacy of bariatric surgery for diabetes treatment in lower-BMI patients, to establish the longevity of anti-diabetes effects, and to understand the exact mechanism of type II diabetes remission after bariatric surgery.
Research presented at the ASMBS conference this morning suggests that there has been little change in single incision minimally invasive surgery (SIMIS), sometimes also known as SPA, for bariatric surgery. While the single incision approach is feasible and safe for laparoscopic adjustable gastric band procedures (LAGB) and vertical sleeve gastrectomy procedures (VSG), the benefits over traditional laparoscopy are elusive, and may only include improved cosmesis with one incision instead of several.
The most robust study to date comparing traditional laparoscopic LAGB to single incision LAGB suggests that the traditional procedure takes less time, results in equivalent post-operative pain, and results in the same weight loss outcomes. Similar outcomes have been reported for single incision laparoscopic vertical sleeve gastrectomy procedures as well. Because of increased operative times and lack of substantial evidence of clinical benefits, surgeons remain skeptical of the SIMIS approach.
Results from the largest randomized clinical trial to date regarding rehabilitation after stroke were published in the May 26th issue of the New England Journal of Medicine. The study called Locomotor Experience Applied Post-Stroke or LEAPS investigated approximately 408 patients recruited from 6 inpatient rehabilitation sites in California and Florida. Approximately two months after having a stroke, all of the participants were assigned to one of three treatment groups: home exercise with a physical therapist, body-weight-supported treadmill training at two months after the stroke (early locomotor training), or body-weight-supported treadmill training at six months after the stroke (late locomotor training). All participants received three sessions per week (90 minutes' duration) for a total to 30 to 36 sessions overall.
Given more than four million stroke survivors experience difficulties in walking, the primary outcome to be measured was improvements in the functional level of walking approximately one year after the stroke (metrics such as walking speed, balance, falls). The investigators hypothesized that locomotor training, especially early locomotor training, would be superior to a home exercise program.
At approximately one year, increased functional walking ability was observed in 52% of all participants. However, interestingly, no significant differences in improvement were found between early locomotor training and home exercise or between late locomotor training and home exercise. On the other hand, compared with the home exercise group, each of the locomotor training groups reported a higher frequency of dizziness or faintness during treatment.
Despite the high incidence of stroke, there remain a limited number of studies examining post-stroke rehabilitation and recovery. This study presents strong evidence to the importance of initiating physical therapy for stroke patients, with over half observing improvements within the year. This study also proves that physical therapy at home can be just as effective as more expensive, locomotor training solutions such as robot-assisted treadmill steppers. Also, not only was the home-based program found to be cheaper, it was also accompanied by fewer risks. As hospitals continue to evaluate best practices on post-stroke care, physical therapy/rehab will undoubtedly remain an important piece, with the optimal methods of delivery being the primary question to be addressed.
Hello from the seventh annual World Conference on Interventional Oncology! We've just wrapped up our first day at WCIO, the international and multidisciplinary meeting for image-guided cancer therapies.
Perhaps not surprising given the current tenor of the health care industry, this year's meeting is highly focused on demonstrating comparative effectiveness as well as cost effectiveness of interventional oncology techniques. Given the wide range of oncologic treatment options and the growing arsenal of interventional modalities, there is keen interest in identifying comparative effectiveness research (CER) to guide treatment decision-making and define care pathways. Furthermore, as health care providers, policymakers, and industry stakeholders prepare for the implementation of national health care reform legislation calling for a greater focus on CER and evidence-based medicine, there is tangible interest in these areas highlighted in this year's WCIO presentations and clinical sessions.
CER in the interventional oncology (IO) space has a two-fold value proposition: to raise the profile of interventional treatment modalities among other medical oncology, radiation therapy and surgical treatment options--typically utilized as an adjuvant, second, or third-line therapy--and also to aid in clinicians' treatment selection among different interventional approaches. Many of the clinical abstracts presented at this year's WCIO meeting are focused on the use of interventional techniques for either therapeutic and/or palliative use, with the intent of demonstrating comparative effectiveness of these modalities. Additionally, there is also a significant focus on quality of life outcomes associated with IO techniques, such as decreased pain and extended months of life, as there is a lot of interest in palliative applications and use among salvage patient populations who may be ineligible for other treatment options.
Beyond the focus on comparative effectiveness research, multidisciplinary care is another major theme of this year's conference. Though "ownership" of interventional procedures is typically shared by interventional radiologists and surgeons, cooperation with and buy in from medical oncologists, radiation oncologists and other specialists, is critical to sustaining a robust interventional oncology program. Multidisciplinary tumor boards, which are increasing in number in line with larger trends in cancer care, can function as a critical pipeline for identifying patients who are eligible for interventional treatments and generating IO volumes. As researchers are exploring expanded applications for interventional modalities to complement medical, radiation and surgical treatments, convening a group of multidisciplinary stakeholders in tumor boards may help broaden the IO referral base by engaging a range of clinicians in the consideration of interventional treatment options. IO platform vendors are also quick to point out that interventional modalities need not necessarily displace other service lines' books of business, but that they can complement other courses of therapy.
We'll continue to live blog from the conference, so stay tuned. Tomorrow, we'll cover some of the most compelling new research in interventional oncology applications.
According to an announcement in Cardiovascular Business, Edwards LifeSciences is scheduled to receive a review of the PMA submission for its transcatheter aortic valve, SAPIEN, on July 20. Pending approval, the SAPIEN will be the first commercially available transcatheter aortic valve in the United States. Designed to provide a minimally invasive alternative to traditional surgical aortic valve replacement, the SAPIEN offers a new therapy to treat severe aortic stenosis in inoperable or high-risk patients. Given the device's great success in Europe, Canada, and Australia, interventional cardiologists and cardiac surgeons in the U.S. are eagerly anticipating its release.
Edwards submitted its PMA application for approval in fall of 2010 following positive results in the Cohort B arm of the pivotal PARTNER trial. Findings demonstrated a significant improvement in mortality for inoperable patients who received the therapy versus those who were managed medically. Moreover, in April of 2011, results of the Cohort A arm, which randomized high-risk patients to SAPIEN versus surgical replacement, were released and showed non-inferiority in mortality.
Technology Insights will continue to monitor the FDA panel and updates in the transcatheter valve space.