Contributor: Karen Gierszewski and Sean Messenger

At the recent meeting of the Society of Interventional Radiology in San Francisco, a potential new indication for embolization was unveiled. Early research shows that benign prostatic hyperplasia may be able to be treated effectively with embolization. In fact, according to the study presented at the SIR meeting in March, the treatment is associated with few serious side effects and may reduce prostate size by more than 30%.

Contributor: Mirel Giugaru

St Jude’s reputation has literally seen its stock fall over the past month—from a six-month high of $44.54 in late March, to hovering in the $38 range for most of April and into May—as the shocking debacle over its Riata leads has shaken physician and investor confidence.

Contributor: Julie McLaughlin

At Thursday’s HRS session the importance of lead safety seemed to be everywhere. Interest in the early morning session “Riata ICD Lead Safety Alert Update” had physicians standing in the hallway outside the presentation room to hear what presenters had to say about the Riata, Riata ST, and Durata leads.

Contributor: Julie McLaughlin

Wednesday’s AF Summit, held at the annual Heart Rhythm Society conference in Boston, brought to light many issues surrounding catheter ablation. A constant theme through the day was the need to improve long-term ablation outcomes. Presenters agreed that catheter ablation to treat paroxysmal atrial fibrillation (AF) is a better alternative than antiarrhythmic drugs, but that there is still more to be done to achieve better longer-term success.

Contributor: Karen Gierszewski

While medical device companies certainly don’t like having to hand over more money to the government than they did before, there are definitely some people who don’t buy in to the theory that the tax will reduce the US medical device industry to a fiery rubble.

Contributor: Karen Gierszewski

The primary argument against the tax from medtech, as we’ve heard before, is that it will severely hinder innovation and prevent companies in the US from developing devices to provide better health care. But there are a number of other interesting issues going on here as well.

Contributor: Karen Gierszewski and Mickel Phung

How early would you want to know if you had Alzheimer’s disease? Undoubtedly one of the scariest conditions out there, new technologies might actually allow Alzheimer’s to be detected much earlier in suspected cases. The new technology in question is an imaging agent that can be used with positron emission tomography (PET) scans to identify clumps of brain proteins called beta amyloid that are potential markers of the disease.

Contributor: Karen Gierszewski

The Eastern European markets are being increasingly recognized as growth opportunities among medical device manufacturers, particularly as growth in the more mature markets, such as the US and large European countries, stagnates. Furthermore, the Eastern European markets might be more reachable for smaller companies without the resources to set up shop in emerging markets further abroad, such as China.

Contributor: Karen Gierszewski

Medtech giant Johnson & Johnson made headlines late in 2011 when it announced its intention to purchase Synthes, a large orthopedic company. This acquisition was, however, brought under review by the EU’s antitrust commission over concerns with how much of the orthopedics market J&J would control.

Contributor: Louise Murphy

Stryker may have gotten a bit more than they bargained for when it acquired Boston Scientific’s neurovascular division in January 2011.

Contributor: Karen Gierszewski

It would seem fairly intuitive that women and men would react differently to medical devices—even a non-medical professional (like myself) could guess that size, hormones, past pregnancies, and the use of oral contraceptives could mess with clinical outcomes. Yet women remain underrepresented in clinical trials.

Contributor: Karen Gierszewski and Mickel Phung

Although the Indian markets have traditionally been more immune to global economic instability, showing strong growth throughout 2008 and 2009, the recent depreciation of the Indian rupee might be a sign that economic difficulties have caught up to the region.

Contributor: Karen Gierszewski and Carmen Chan

Allergan has historically had a stranglehold in the US facial injectable market, particularly in the botulinum toxin market, where the company’s BOTOX Cosmetic brand has become synonymous with the product itself. In recent years, however, it was looking like Allergan’s uncontested reign was coming to an end, with a variety of new companies launching BTX and dermal filler products.

Contributor: Karen Gierszewski

The industry can breathe a sigh of relief: confidence in the US medtech market appeared to be recovering in Q4 2011 after fairly steep falls in Q2 and Q3. This seems to be happening in line with a tentatively optimistic outlook on the US economy: unemployment is declining, the housing market is looking healthier, and tax revenues are recovering. But can this rising confidence be maintained throughout the rest of 2012?

Contributor: Karen Gierszewski

It’s hard to remember the days when a debate at dinner over a minor piece of trivia couldn’t be resolved by someone quickly whipping out their smartphone and googling the answer. Welcome to 2012, when babies can’t figure out magazines because they’re so used to iPads. And our leaps and bounds in technology are affecting health care, too—medical-related apps are one of the top ten trends to look out for in the medtech world in 2012.

Contributor: Fareed Hameed

Several topics were of particular interest at the 2012 Society of Interventional Radiology (SIR) conference , ranging from advanced clinical techniques in peripheral revascularization and embolization to the regulatory and economic climate for IR practice in the US.

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 at last year's 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 demonstrated no significant difference in stroke rates between TAVR and surgical aortic valve replacement in the PARTNER A arm of the trial.

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.

Contributor: Fareed Hameed

One of the highlights of the Tuesday sessions of SIR was the very lively Hot Topics debate, featuring 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.

Contributor: Karen Gierszewski and Mickel Phung

There has been much discussion in the US lately surrounding ACOs, a piece of the Affordable Care Act anticipated to be implemented sometime in 2012. 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?

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.

Contributor: Karen Gierszewski

Historically, patients haven’t gotten too involved in selecting products to be used for their medical treatments—patients have generally deferred to their doctor to select an appropriate drug, knee implant, or cardiac rhythm management device brand. But this seems to be changing—patients are increasingly wanting to be involved in their own health care.

Contributor: Karen Gierszewski

Faulty implants in both the US (metal-on-metal hip implants) and Europe (breast implants) have put pressure on regulatory bodies to increase postmarket surveillance, as we’ve discussed previously . But this does leave an interesting niche for manufacturers—are there devices that can be developed that can specifically be used for surveillance postapproval?

Contributor: Karen Gierszewski

As women worldwide celebrate International Women’s Day—or in my case, discover that it’s International Women’s Day when trying to google something this morning—I thought it might be relevant to take a quick look at the latest and greatest in women’s health in the medical device world.

Contributor: Karen Gierszewski and Sara Scharf

Having recently commented on the appeal of investing in depressed European countries, an article in the New York Times caught our attention. This article discusses how, recently, the appeals panel of the World Trade Organization ruled that China has to eliminate its export taxes and quotas on nine widely-used minerals.

Contributor: Mickel Phung

Implementation of an electronic health record (EHR) is a gigantic undertaking for a practice or hospital, both financially and logistically. Properly training staff and physicians to break old habits and utilize the system to a level to qualify for meaningful use is an even bigger task. With meaningful use Stage 2 approaching however, another spectre looms in the distance, the health information exchange (HIE). One of the proposed criteria for Stage 2 is that exchange of data will no longer simply be tested, but actual exchange will be required.

Contributor: Alex Jablokow

This Saturday, at Western University, a group of students will have the opportunity to experience first hand what life as an MRG Analyst is like. They will be given an actual MRG case to analyze. Competing against other teams, they will perform a full market and company analysis, and be judged on the results.

Contributor: Karen Gierszewski

It’s been interesting to note that in the past few months several companies have chosen to separate their medtech and pharma units.

Contributors: Karen Gierszewski, Sara Scharf and Aaron McCracken

The popularity of robotic-assisted surgery has exploded in recent years, with these systems rapidly becoming a “must have” for high-end health care facilities. This technique has been particularly rapidly adopted for urology procedures such as prostatectomies due to the fact that the angles used in these procedures make traditional laparoscopy uncomfortable and difficult for surgeons—nearly 80% of prostatectomies removed in the US were removed with Intuitive Surgical’s da Vinci system, by far the most common surgical robot in use. But do the benefits of these robots really justify the cost?

Contributors: Karen Gierszewski and Sara Scharf

A lot of companies lately have been heading over to the emerging Chinese, Indian, and Brazilian markets to set up research & development (R&D) and manufacturing facilities. This is usually a smart move for large companies because they can benefit from lower manufacturing and labour costs while having convenient access to these large and fast-growing markets.

Contributor: Mickel Phung

Only 50% of family practitioners stated they were satisfied overall with their Electronic Health Records (EHRs), and 30% stated they were dissatisfied. The most interesting statistic however from a vendor’s perspective is that only 38% of practitioners stated they would purchase their system again!

Contributor: Mickel Phung

HIMSS 2012 has been eagerly awaiting details of Meaningful Use Stage 2, and officials from ONC and CMS packed the conference room and even required the opening of a second space to accommodate everyone. So what details were announced?

Contributor: Karen Gierszewski

Over the last few years, a slowdown in the growth rate of the US medtech industry has occurred—while 2004 yielded a growth rate of more than 15%, 2010 showed a much more modest 3.5% expansion. It’s easy to quickly blame this on the allegedly burdensome Food and Drug Administration (FDA) approval process or economic difficulties, but are there other factors at play here?

Contributor: Karen Gierszewski, Mashkur Reza, Kyle Verleyen

There have been a couple interesting and unexpected events in the orthopedic biomaterial market over the last few weeks. First, BioMimetic Therapeutics has not yet received Food and Drug Administration approval for its Augment Bone Graft , which was originally anticipated to enter the market in 2012 following a positive recommendation for approval in May 2011 .

Contributor: Karen Gierszewski

As Valentine’s day 2012 rolls around, we can barely go anywhere without being inundated with hearts—heart-shaped decorations, heart-shaped candies, teddy bears holding hearts. All great indications of a fun, happy holiday. But what about for those of us nursing a broken heart this year?

Contributor: Karen Gierszewski

Several instances of faulty implants have recently put pressure on regulatory bodies to examine if they need to better track devices postapproval. In the US, this pressure has occurred amid concerns over metal-on-metal hip implants.

Contributor: Karen Gierszewski

I think we can all agree that as we come out of a rough 2011 for medtech, a number of questions are weighing on everyone’s minds for 2012. On January 31, MRG COO Ken McLaren answered these questions with his presentation on the top 10 trends that medtech companies should look out for this year.

Contributor: Karen Gierszewski

Both Medtronic and Boston Scientific have been hit with multimillion dollar tax claims by the US Internal Revenue Service (IRS). Combined, the two companies could owe the IRS approximately $2 billion, although both companies plan to contest the allegations in US Tax Court.

Contributor: Karen Gierszewski

The first time I came across an article on hacking into digital medical devices, I dismissed it pretty quickly. After all, what could be the possible motivation for hacking an insulin pump or a pacemaker? But then I came across another one. And then another one. Maybe this topic does deserve some attention?

Contributors: Karen Gierszewski and Sara Scharf

The threat of pay cuts for doctors treating Medicare patients still looms. While the implication for medical device manufacturers will not be as obvious as for the reimbursement prepayment audits, discussed yesterday, it could potentially hinder the adoption of electronic medical records (EMRs) among physician practices due to lower incomes in general.

Contributors: Karen Gierszewski and Sara Scharf

Physicians have been reacting to the news that the CMS is rolling out a new pre-reimbursement review system across 11 states. This system would involve challenging doctors for proof that a procedure is necessary before granting reimbursement, which is a significant change from the status quo.

Contributors: Karen Gierszewski and Sara Scharf

With the economic turmoil affecting the European countries, it seems natural that the medtech industry would suffer the consequences. But how exactly are each of the big five European countries feeling the effects of economic instability? Are recent health care reforms substantially changing anything?

Contributor: Karen Gierszewski

In 2011, a number of major mergers and acquisitions considerably changed the landscape of the global medtech market. The most interesting deal of the year was made by pharmaceutical giant Johnson & Johnson, which has indicated its intent to acquire Synthes—this deal is so interesting, in fact, that it is still under antitrust review by the European Commission.

Contributors: Karen Gierszewski and Shriram Venkataramana

In the endoscopy device market, the reprocessing of single-use devices (SUDs) has historically been an annoyance of original equipment manufacturers such as Covidien, Ethicon Endo-Surgery, and Stryker. While historically major manufacturers have been vocal in their position against reprocessing, a few have recently had a change of heart.

Contributor: Karen Gierszewski

I know we’ve focused a lot on Food and Drug Administration (FDA) regulations and other innovation concerns in the US in prior blog posts, but this article was too good to pass up.

Contributors: Karen Gierszewski

Physicians in the US are increasingly worried that innovation in the US has taken a bad turn. This has stemmed partly from two topics we’ve discussed before: the purportedly strict FDA approval process and the fact that many new devices released in the US have been brought under fire—most notably, metal-on-metal hip implants.

Contributors: Karen Gierszewski

Product development in the medtech space is always ongoing, with lots of interesting new devices being released each year. But are all new products really worth it? Recent research says no.

Contributors: Karen Gierszewski and Sara Scharf

Medtech companies across the US are understandably upset because of the looming medical device tax that was signed into law in 2010 as part of the Affordable Care Act. Under this act, companies will be required to pay a 2.3% tax on their total revenues starting in 2013. Many industry leaders have spoken out against the tax, saying that it will stifle innovation—this tax could be particularly detrimental to smaller companies looking to bring new innovations to the US. Furthermore, the tax does not take into account whether or not a company is profitable.

Contributor: Karen Gierszewski and Mickel Phung

As the time frame for year one of the meaningful use of electronic medical records (EMR) incentive program draws to a close, US policymakers will no doubt be examining what caused the adoption of this program to be so lackluster.

Contributor: Karen Gierszewski

When thinking about medical tourism—involving posh resorts where you can get a complex cardiovascular procedure thrown in—the BRIC markets come immediately to mind. And that’s for a good reason—Brazil, India, and China are all becoming increasingly popular destinations for medical procedures because of low costs, well-trained surgeons (in the urban centers, that is), and the ability for patients to bypass lengthy waiting lists in their own countries.

Contributor: Karen Gierszewski

As we commented earlier , the Chinese medtech market is gaining considerable attention among major medical device manufacturers because of a rapidly expanding economy and fast procedure growth. But, it is worth noting that in many markets much of this growth stems from a small procedure base, which makes the growth numbers somewhat inflated. So when will China and the other BRIC countries actually reach a point to make a dent in the revenues of large international medtech companies?

Contributors: Karen Gierszewski and Daniel Brown

On October 1, 2011, the New York Times reported that metal-on-metal hip implants have been associated with severe and permanent side effects, with the article even saying that one surgeon found a “biological dead zone” when replacing a failed metal-on-metal hip in a patient.

Contributor: Alex Jablokow

Back in 2008, at the height of the financial crisis, many of our clients called us and asked for our take on how the market was doing in general. How closely tied is confidence in medtech to confidence in the economy? How were procedure volumes likely to change?

Contributor: Karen Gierszewski

I was wracking my brain this morning to come up with an appropriate Halloween-themed blogpost that was somehow related to medical devices. The pharma industry has it easy—the so-called ‘zombie virus’ creates a great opportunity for a spooky, yet relevant blog entry. As I was checking out people’s costumes on my way into work this morning though it suddenly came to me: vampire face lifts.

Contributor: Karen Gierszewski

A trend that is becoming painfully obvious in the US medtech market is the increasing cost-consciousness of hospitals, in response to both economic and governmental pressures.

Contributors: Karen Gierszewski, Mashkur Reza and Ian Swanson

Traditionally, the US Food and Drug Administration (FDA) and the European CE mark have been at opposite ends of the approval spectrum. While the FDA approval process has typically been long, stringent, and expensive, CE marking is much easier to obtain (on a relative scale, of course!).

Contributor: April Lee

On Thursday, September 29th, 2011, MRG participated in the annual Heart & Stroke Big Bike Fundraiser to raise both awareness and money for the Heart & Stroke Foundation.

Contributor: Karen Gierszewski

Over the next few years, some of the most dramatic medical procedure volume growth will be seen in China, an emerging economic powerhouse.

Contributor: Karen Gierszewski

While many markets still struggle to reach pre-2008 levels, the news that health care insurance costs rose sharply in the US in 2011—as reported by the New York Times —was not welcomed.