In the past few weeks we've seen a bunch of ink spilled around the treatment of vertebral compression fractures. While always a controversial topic, it seems the discussion has gotten especially vibrant, culminating in new guidelines released by the American Academy of Orthopedic Surgeons (AAOS). On Monday, AAOS approved and released clinical practice guidelines that recommend against the use of vertebroplasty--a procedure in which bone cement is inserted percutaneously into a fractured vertebra.
Generated by a working group that had completed an extensive review of clinical literature to arrive at an evidence-based conclusion, the guidelines concluded that there was little evidence to suggest that vertebroplasty offers any real clinical benefit. While the literature that informed the guidelines spanned several decades, two major studies which appeared in the same issue of the New England Journal of Medicine in 2009, were especially important to their conclusions. Both of these studies compared vertebroplasty to a sham procedure and found no measurable clinical benefit among patients that received vertebroplasty.
While the guidelines were especially negative towards vertebroplasty, AAOS did not show favor to kyphoplasty either, expressing a weak recommendation for its use in patients. Though this recommendation does at least suggest the therapy may be useful, it shows little confidence that this is the case.
Recent movements on the industry front don't reflect such middling clinical support for these procedures. Only a few days before AAOS published its guidelines, ArthroCare announced that it had received FDA clearance for its Parallax Contour Vertebral Augmentation Device, the second kyphoplasty technology to receive FDA clearance in the past couple of months (CareFusion had a balloon approved in August as reported previously on the Pipeline). After being a single-vendor market for so long, these back to back approvals are a big change, and suggest that industry still sees kyphoplasty as a big growth opportunity.
Next week, members of Technology Insights will be headed to Orlando to attend the annual scientific sessions of the North American Spine Society (NASS), and we will be sure to keep you all abreast of any additional updates to the current controversy over vertebroplasty and kyphoplasty, as well as all other concerns in the spine world. Look for updates here on the Pipeline.
Brian Maher, Technology Insights
Several years ago, women's health vendor Hologic introduced the concept of 3D digital breast tomosynthesis, a new technology thought to revolutionize the breast imaging specialty by increasing the performance of standard 2D digital mammography.
Interest from the health care community immediately sparked, with many experts indicating breast tomosynthesis could ultimately supplant digital mammography as the modality of choice for the screening and diagnosis breast cancer in any setting.
Despite its promise, the years came and went, but still no tomosynthesis product. The lack of clinical data, a very complicated FDA reviewal process, unclear indications for use, and myriad other factors were, and still are, to blame. Now, it appears one very important and cumbersome barrier to tomosynethsis development is beginning to budge.
Last Friday, the FDA's Medical Devices Advisory Committee—a group consisting of clinicians, statisticians, patient advocates, and industry representatives - convened to advise the FDA on whether or not to proceed with approval for Hologic's Selenia Dimensions 3D tomosynthesis system.
In a 12-0 vote, the panel overwhelmingly, and somewhat surprisingly, came out in favor of the FDA approving the device and moving forward in the pre-market approval (PMA) process. While many radiologists, technologists, administrators, and members of industry anxiously await the final decions from the FDA, last week's panel recommendation to proceed in the formal FDA review process marks a historic first step towards a definitive answer.
Read more »
While transcatheter valves and the PARTNER trial clearly took center stage at this year's TCT meeting, a host of other clinical trials were presented as well, including the continuation of follow-up on some major drug-eluting stent trials. As a round-up of the conference, please see below for a brief overview of each of the major clinical trials presented at the meeting.
On Wednesday Technology Insights traveled to Baltimore to attend a Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) meeting on the on- and off-label use of Bone Morphogenetic Proteins (BMPs). BMPs, growth factors that have the potential of inducing the formation of new bone, have been commercially available since 2001 and have risen dramatically in usage since that time--evidence presented at this years American Academy of Orthopedic Surgeons (AAOS) annual scientific sessions demonstrated that their use had quadrupled from 2003 to 2007. In our discussions with spine and orthopedic programs across the country, it's clear that this rapid growth has continued, and largely in an officially 'off-label' manner. With limited PMA and HDE approvals for the use of these products, it's no suprise that the AAOS study (published in Spine this month) estimated nearly 85 percent of use is off-label.
While there is not an open coverage decision for CMS in terms of the use of BMPs, the agency is investigating these products to determine to what extent they improve clinically meaningful health outcomes (pain, patient function, and adverse events). To that end, MEDCAC members gathered to evaluate the available clinical evidence and vote on its adequacy. The day's conversations were greatly helped by a recently published technology assessment on BMPs from the Agency for Healthcare Research and Quality (AHRQ).
Because pain and adverse events were metrics to evaluate BMPs, the panel's immediate reaction was the need to determine the relative pain levels and adverse events of performing an autograft, which generally necessitates a separate incision into the patient to harvest bone material and thereby causes pain and the heightened threat of adverse events. Ultimately, MEDCAC was voting on the adequacy of the clinical evidence to determine whether or not BMPs improve on the clinically meaningful health outcomes, and given the lack of research comparing BMP use to autografts, they could not come down firmly on either side.
In the end, the committee rated the adequacy of the clinical evidence for on label use in the lumbar spine and for tibial fractures with much higher confidence than any off-label use of the product, though they did express intermediate confidence on its use in cervical spine cases. They also rated with low to intermediate confidence the adequacy of the clinical data to be generalizable to either Medicare beneficiaries or to community based settings.
Without a coverage decision hanging over the discussions, the implications of the panel's conclusions are unclear. Still, the session reveals a CMS concern on the growing use of BMPs and what clinical benefit they are providing. It may be that this fits into the growing pressure that payers are laying on providers and industry--as we reported in the Pipeline earlier this month--but it also can be read as a call for researchers and industry to provide more salient data to the public so that better clinical decisions can be made. Either way, we'll continue to follow this closely and keep you informed on any developments.
The most highly anticipated cardiovascular technology trial in years debuted today to exciting, impressive results. Transcatheter aortic valve implantation (TAVI) reported strikingly reduced mortality and recurrent hospitalizations when compared to standard therapy for patients with severe aortic stenosis.
As we've been reporting all week, the PARTNER trial from Edwards Lifesciences debuted today at TCT, representing the first U.S. results for the transcatheter aortic valve, SAPIEN. The results hit the internet last night in the online version of the New England Journal of Medicine. Co-hort B of the trial, which randomized non-operable patients with severe aortic stenosis to the transcather valve or standard medical therapy, is the first step toward commercialization of the therapy and FDA approval. While this arm focuses on non-operable, high-risk patients, Co-hort A of the trial, which randomizes high-risk patients against traditional surgery, will report results in March at the American College of Cardiology (ACC) meeting. How the results from both arms of the trial are interpreted by interventionalists, surgeons and the FDA could have a meaningful impact on how aggressive physicians and hospitals pursue transcatheter valve treatment, the most disruptive cardiovascular intervention since the drug-eluting stent.
Read more »
TCT dedicated a day-long session today to device-based approaches for heart failure, signaling the enthusiasm that procedural approaches may have for this afflicted (and large) population. While TCT typically is a conference focused on catheter-based interventions, in recent years it has been attempting to recruit surgeons, as well. Given the mixed audience and the potential for interventional cardiologists to play a role in future heart failure therapy, both as referrers and even proceduralists, the session was heavily attended.
The session posed some interesting questions regarding the future use of destination therapy ventricular assist devices (VADs) for patients with less advanced HF. Today, VADs are implanted in patients with advanced heart failure when the disease is very progressed, and patients often have many other concurrent conditions. CMS currently extended destination therapy coverage to class IV heart failure patients who failed medical management with beta-blockers, ACE inhibitors for 45 out of the last 60 days or are balloon pump dependent for seven days or IV inotrope dependent for 14 days. Because the application of VADs is limited in this group, implanting devices earlier has the potential to significantly improve quality of life, mortality, and functional status for more patients (as many as 300,000 who are candidates for mechanical circulatory support).
To address this challenge, the National Heart, Lung, and Blood Institute (NHLBI)'s is planning to conduct a trial--called Randomized Evaluation of VAD InterVEntion before Inotropic Therapy (REVIVE-IT)--which will study advanced heart failure patients who are neither inotrope-dependent nor exercise-intolerant and have not developed serious immobility or end-organ damage as a result of their HF. The TCT presenter noted that the trial is still pending, as two institutions with slightly different proposals are being considered, and it is yet to be determined whether the HeartMate II VAD or the HeartWare device will be used. This trial could greatly affect patient selection for VADs in the future as well as increase the number of patients who can benefit from this novel treatment option; however, the proposed CMS national coverage decision stating that VADs may only be able to be used in patients with Class IV, end-stage heart failure who are not candidates for heart transplant, may limit the potential for more wide-spread availability of VADs for other HF patients. Technology Insights will continue to follow this debate and updates on REVIVE-IT trial as it launches.
In Technology Insights we have recently been undergoing an update to our destination therapy VAD center research and analysis. If you are considering pursuing this opportunity, please contact your Dedicated Advisor at TechInsightsRequests@advisory.com to see how we can assist you in your business plan development.
Unlike yesterday's Aortic Valve Summit, which wasted no time in focusing on transcatheter therapies in light of the excitement of the PARTNER trial, today's Mitral Valve Summit spent considerably more time focusing on surgical innovations. Considering the innovations in mitral valve repair, including surgical robotics, transcatheter mitral therapies are clearly competing in a more crowded minimally invasive market.
Given the complexity of mitral valve disease and treatment, numerous percutaneous therapies are in development with varying approaches. The most well-known and furthest to market, Abbott's MitraClip edge-to-edge leaflet repair, was heavily featured. Data from its pivotal Everest II trial were presented at ACC this spring and the company is now in discussions with the FDA. More detailed data from Everest II will be presented tomorrow morning prior to the late-breaking trials. We'll be paying careful attention to discussions over whether recurrent mitral regurgitation is acceptable given improved heart failure status and whether clinicians believe the use of this device precludes future surgical intervention in patients that may require additional therapy.
Dr. Frederick G. St. Goar--original creator of the MitraClip device and interventional cardiologist in Mountain View, CA--presented the next-generation iterations of the MitraClip currently in development at Abbott. The new design, which looks to improve both clip deployment and arm length, hopes to both expand indications for the device and ameliorate device delivery. The current model uses an s-lock deployment system and can run into delayed attachment complications; a newer model employs an axial deployment system that will eliminate this issue. Likewise, current clip length is roughly 7.5 mm, a length prohibitive for conditions such as excessive leaflet redundancy or tricuspid disease. With a new longer design, Abbott hopes to improve valve "clipping" and eventually expand the device's indications.
The remainder of the afternoon showcased a variety of transcatheter mitral valve devices that utilize either coronary sinus annuloplasty or direct annuloplasty repair techniques. Many of these devices such as the Monarc, Carillon, or Viacor systems have seen advanced use in Europe, but have not reached clinical study here in the U.S. Two exciting therapies that have been studied largely in animal research were presented; one for mitral valve therapy, and the other surprisingly for aortic valve therapy. The first--the Guided Delivery System presented by Mark Reisman from Swedish Heart and Vascular Institute--is a non-implanted device procedure that uses ultrasound therapy to remodel the valve annulus. This device uses heat to shrink the mitral annulus, which in turn reduces mitral regurgitation. This option could provide a procedure with minimal learning curve that theoretically creates no damage to the native valve. Further human study is required.
The second "futuristic" therapy presented was actually a transcatheter aortic valve technology called the ValveExchange. The device is still in early development and looks to help with long-term valve durability by providing the option to "swap out" valve leaflets years after an operation. This two-component system implants a "valve docking station" that an exchangeable frame holding the valve leaflets can be attached to. This option could be ideal for a younger patient population offering a minimally invasive therapy should the original implant weaken in the long-term. Like the previous device, this is device will require extensive clinical study, but also could have opportunity in the mitral valve space.
Tomorrow's presentations include updated results from MitraClip's Everest II study and the eagerly anticipated first results presentation of the pivotal FDA PARTNER trial of Edwards SAPIEN device.
Greetings from the 2010 Transcatheter Cardiovascular Therapeutics conference! The cardiovascular team here at Technology Insights is coming to you live from the Washington, D.C. Convention Center. Today kicks off Day 1 of the scientific symposia covering a variety of clinical topics such as drug-eluting stents, interventional innovation, vascular technologies, and the eagerly anticipated valve disease summit. In the standing room-only Valve Disease Summit, interventional cardiologists--and increasingly cardiac surgeons--have gathered to hear about the latest news on therapies for aortic stenosis, most notably transcatheter aortic valve implantation (TAVI). This is the second year of this particular summit and with the initial results from the pivotal PARTNER trial results scheduled for presentation on Thursday, there is a clear buzz in the air focusing on all things transcatheter valves.
Read more »