MRG Medical Device Market Blog

Blog > March 2012

Contributor: Ian Swanson

When the one year results from the PARTNER US pivotal trial for Edwards Lifesciences’ SAPIEN transcatheter aortic valve replacement (TAVR) device were announced last year at the American College of Cardiology (ACC) conference, they demonstrated the great potential for this technology to treat aortic stenosis. They also, however, indicated some concerns with the technology, namely the stroke risk.  To Edwards Lifesciences’ relief, however, two-year results from this trial—which were released this week at this year’s ACC conference—demonstrated no significant difference in stroke rates between TAVR and surgical aortic valve replacement in the PARTNER A arm of the trial.  Furthermore, at two years there was no significant difference in mortality between the transcatheter approach and surgery.
These new results could be crucial for expanding the use of TAVR into a new subset of patients. As of early 2012, Edwards Lifesciences’ SAPIEN valve was only approved for use in patients considered too high risk to undergo surgery—a decision that continues to be supported by positive results in these patients from the PARTNER B arm of the trial. The PARTNER A arm, however, examines patients who are surgical candidates even though their risk of complications is high. If TAVR can make headway into the surgical patient pool, the revenue potential will be huge—the Food and Drug Administration’s decision on approval in high-risk surgical candidates is anticipated in the upcoming months.

Expanding the patient population eligible for TAVR therapy was a hot topic at ACC.12, with multiple surgeons and interventionalists on both sides of the argument.  Debates focused on the use of heart teams to select patients, how best to stratify patient risk, where the procedure should be performed, and what type of imaging should be used for the procedure.
Of note in the PARTNER A trial results was the importance of paravalvular leaks—something infrequently seen in surgical valve replacement but often associated in TAVR—which are shown to be an important predictor of mortality.  This result and the previously mentioned debates demonstrate the early stage this therapy is at, with best practice for these procedures currently under study and in evolution.  Furthermore, there remain exciting opportunities for new and improved devices to further improve this procedure and undoubtedly add more fuel to the debate about appropriate use of this technology.  
Posted: 3/29/2012 3:03:02 PM

Contributor: Ian Swanson

With late breaking trials, spirited debates, and hundreds of other great talks, the American College of Cardiology’s 2012 (ACC.12) annual meeting in Chicago this past weekend provided a ton of exciting news. Standing out from the crowd was a panel of talks on renal denervation, a promising catheter-based treatment for hypertension, and clearly the topic of the week.

Hypertension represents one of the most common diseases around the world and is thought to be increasing in prevalence due to western habits and lifestyle. There are a myriad of complications associated with hypertension, including chronic kidney disease, stroke, and coronary artery disease, among others. Traditionally treated with medication, there remains a significant portion of patients whose blood pressure cannot be controlled by drugs, placing them at a high risk for developing these complications. This large patient population that can’t be treated pharmaceutically offers a potential gold mine for manufacturers.

During a renal denervation procedure, a radiofrequency ablation catheter is fed through the groin into the renal arteries and creates a series of lesions, ablating the renal sympathetic nerve. Results presented at the ACC.12 meeting demonstrated that renal denervation continues to be successful 3 years post procedure, resulting in a marked decrease in blood pressure that appears sustained and stable. Furthermore, results presented during the panel suggested that 100% of patients responded to the treatment after 3 years. These results are very exciting—previous updates at the 1- and 2-year marks post procedure showed only 64% and 82%, respectively, of patients responded.

Medtronic’s acquisition of Ardian has given it the lead in the renal denervation field, with its product having already attained CE approval in Europe and the largest set of clinical data thus far. However, there remains some uncertainty surrounding the procedure. For example, some skeptics have raised questions about the company’s SYMPLICITY HTN-1 and HTN-2 trials because ambulatory blood pressure monitoring was not extensively used and there was no sham procedure that could have generated a placebo response.

Medtronic is, however, addressing these concerns in the SYMPLICITY HTN-3 pivotal trial in the US, which is currently enrolling patients. Results from the HTN-3 trial, and real world usage from European centers, will help to answer the lingering questions about renal denervation. And saying that there is great potential for this treatment is almost understating its potential impact—positive results could push renal denervation to become one of the biggest medical device successes to date. Everyone will definitely be keeping an eye on this technology through 2012.
Posted: 3/28/2012 12:23:06 PM

Contributor: Fareed Hameed

One of the highlights of the Tuesday sessions of the Society for Interventional Radiology (SIR) was the very lively Hot Topics debate. This session featured teams of two interventionists arguing for or against current topics of interest. One of the big recent developments in the industry is Medtronics' $1 billion acquisition of Ardian for their renal denervation technology. This has generated some buzz both through industry and clinicians, leaving many wondering about the future role of renal artery stenting and angioplasty in the face of this emerging denervation technology.

Right off the bat, Dr. Tim Murphy conceded the negative trial data from the STAR and ASTRAL trials. However he also did stress the well known criticisms surrounding both trials. Dr. Murphy further pointed out that there would be cases where denervation would not be indicated and where blood pressure controlling drugs are ineffective, thereby keeping a role for renal stenting.
On the other hand, Dr. Mark Sapoval argued for leaving renal stenting behind and embracing denervation, as well as focus on better medical management. He stressed that renal stenting has shown no benefit over medical management by any measure in trials, but comes with complications such as vessel perforation and hemorrhage. Furthermore denervation has shown a decrease in blood pressure, one of the key end points in therapy. Hope from future trials for stenting, such as CORAL is lukewarm and not expected to change perception. The new tool, renal denervation, for patients with no stenosis or other cause of secondary hypertension, is the answer.

Dr. Thomas Soh replied by arguing that the debate is moot because both treatment options, denervation and stenting, are non-competitive and complementary. He said that if the indications and contraindications for both were such that the indications for one were the contraindications for the other, and vice versa, suggesting a possible lack of complete overlap in terms of eligible patient populations.

Dr. Alan Matsumoto noted however, that less than 5% of hypertension was due to renal artery stenosis. Hypertension treatment therefore, would be better treated with denervation. He further argued that the current trials for renal artery stenting were poorly designed and haven't even determined the right type of patients to treat, so the evidence is weak. Dr. Matsumoto ended his rebuttal stating that interventional radiologists needed to adapt their treatment for hypertension or be left behind.
Overall, the judging panel narrowly agreed that there would still be a continued role for renal artery stenting and angioplasty. Although denervation is not expected to completely eliminate renal stenting, procedural growth will continue to fall due to lack of clinical safety and efficacy, as well as the relative uncertainty as to which patients would truly benefit from the procedure.
Posted: 3/28/2012 9:12:42 AM

Contributor: Karen Gierszewski and Mickel Phung

There has been much discussion in the US lately surrounding accountable care organizations (ACOs), a piece of the Affordable Care Act anticipated to be implemented sometime in 2012. In simple terms, these organizations are networks that are designed to bring multiple levels of health care together, including physicians, clinics, and hospitals, with the idea being that they all share responsibility for providing care to patients under the Medicare system. These organizations offer a lot of benefits in theory—they are designed to improve the overall quality of health care in the US while lowering health care costs. How is this possible? Well, the argument is that the current system provides incentives for physicians to overproduce (such as by conducting more tests than are medically necessary) or to pick treatments based on reimbursement levels (and thus profitability), rather than what might be in the best interest of the patient.

Of course, medical device manufacturers are concerned—it’s possible that the ACOs could cause physicians to opt for lower-cost treatment alternatives, such as drugs or lower-cost devices, in order to earn the financial incentives that will be provided for meeting the goals of the program. Taking that point a little further, it might become difficult for patients in the US to access innovative but costly new therapies available because physicians and hospitals may not have the incentives to offer them. Let’s not forget (how can we, really) the fact that manufacturers are already upset over the so-called “innovation crisis” in the US—this will definitely add some ammunition to that argument, for better or for worse.

Device manufacturers have not been sitting idly by—they put forward some recommendations to the Centers for Medicare & Medicaid Services (CMS) that might have made ACOs more palatable for them. AdvaMed, the medical device manufacturer lobby group, was not, however, happy with the final rule by the CMS, which was released in October 2011. In fact, this final ruling reduced the number of quality measures from 65 to 33, further boosting fears that doctors and hospitals will not have adequate motivation to pick high-quality, but more expensive, devices. The CMS did, however, state that more quality measures could be added in the future…so we probably haven’t seen the end of this fight yet.
Posted: 3/27/2012 9:07:35 AM

Contributor: Karen Gierszewski

As we’ve heard multiple times before, the Food and Drug Administration (FDA) really takes a beating from medtech manufacturers and patient advocacy groups because of the long medical device approval times in the US—the fear is that the US will fall behind in terms of innovation, with the most advanced devices entering other markets, such as Europe, years before they become available in the US.

But how much blame does the FDA really deserve? The FDA’s responsibilities are pretty overwhelming—they have to ensure the safety of every medical product before and after it is approved, regardless of whether or not it was manufactured in the US. And this article states that more than eight million shipments of medical products arrive at US ports every year. The organization has definitely taken the blame when approved devices haven’t performed as planned…take the recent scandal with metal-on-metal hip implants, for example. So how can the FDA ensure the safety of US citizens while satisfying the need for innovative technology?

The answer might be simple in principle: more funding. This article in the Boston Globe discusses how the FDA is chronically underfunded, which makes it difficult for the organization to manage all of its responsibilities. Furthermore, staff turnover continues to be a problem, which lengthens the process because the new hire will need to spend time getting up to speed before product evaluations can continue.

Nonetheless, the FDA has acknowledged the long approval times in its strategic priorities press release for 2012 and vowed (albeit somewhat vaguely) to better manage the approval process. This promise has been reinforced by the recent agreement between the FDA and the medical device industry on user fees—the industry agreed to pay $595 million in user fees over five years and in return the FDA agreed to set certain performance goals, including reducing overall approval times.

Maybe this whole issue would be solved if the FDA had more funding…but then again, it would be hard to find any group that would argue that they don’t need more funding!
Posted: 3/21/2012 10:51:53 AM

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