MRG Medical Device Market Blog

Abbott and St. Jude Medical decide against merger but strengthen partnership

Wed, 23 May 2012 08:57:02 GMT

Contributor: Karen Gierszewski and Julie McLaughlin

Recently, St. Jude Medical and Abbott announced that they were strengthening their alliance to sell cardiovascular devices in the US. This announcement follows widespread speculation that the two companies would merge—both companies have strong product portfolios but do not have the breadth of product lines on their own to compete with the big name cardiovascular companies such as Medtronic and Boston Scientific.

Annual SIR meeting reveals potential new indication for embolization

Wed, 16 May 2012 16:55:30 GMT

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%.

Trials and tribulations for St. Jude Medical’s Riata ICD lead

Fri, 11 May 2012 11:48:24 GMT

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.

Continued controversies around transvenous leads, from HRS

Fri, 11 May 2012 11:48:24 GMT

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.

The rise of contact force-sensing technology, from HRS

Thu, 10 May 2012 11:10:23 GMT

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.

The medical device excise tax: Not so bad (Part 2)

Thu, 10 May 2012 09:02:26 GMT

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.

The medical device excise tax: The horrors (Part 1)

Wed, 09 May 2012 10:04:04 GMT

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.

Is the early detection of Alzheimer’s a good thing?

Thu, 03 May 2012 10:01:36 GMT

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.

Medtech companies look beyond BRIC countries for expansion

Mon, 30 Apr 2012 15:44:08 GMT

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.

J&J gets the go-ahead to acquire Synthes at the expense of its trauma device unit

Wed, 25 Apr 2012 11:44:09 GMT

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.

The Wingspan Stent saga, from AANS

Fri, 20 Apr 2012 14:01:55 GMT

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.

More swings at the FDA: The underrepresentation of women in clinical trials

Fri, 20 Apr 2012 09:09:32 GMT

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.

Is the Indian market as immune to economic fluctuations as we thought?

Tue, 17 Apr 2012 12:03:58 GMT

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.

Xeomin vs BOTOX Cosmetic: Allergan comes out on top in litigation

Thu, 12 Apr 2012 10:17:02 GMT

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.

Q4 2011 MCI: Too soon to celebrate?

Mon, 09 Apr 2012 11:25:29 GMT

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?

Medtech jumps on board as the world goes mobile

Wed, 04 Apr 2012 09:27:01 GMT

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.

SIR 2012 Hot Topics: Premarket Approvals, Off-Label Use and the Future of Interventional Radiology

Mon, 02 Apr 2012 09:50:51 GMT

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.

TAVR continues to impress, from ACC.12

Thu, 29 Mar 2012 15:03:02 GMT

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.

More on renal denervation, from ACC.12

Wed, 28 Mar 2012 12:23:06 GMT

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.

Renal denervation vs. renal artery stenting: a debate from day three of SIR

Wed, 28 Mar 2012 09:12:42 GMT

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.

Who’s accounting for medical device manufacturers? ACOs and their impact on the medtech industry

Tue, 27 Mar 2012 09:07:35 GMT

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?

How much blame does the FDA deserve?

Wed, 21 Mar 2012 10:51:53 GMT

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.

The rising importance of patient experience

Fri, 16 Mar 2012 13:24:53 GMT

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.

How demand for better postmarket surveillance might lead to a new medtech niche

Tue, 13 Mar 2012 10:27:18 GMT

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?

Happy International Women’s Day: Transcervical female sterilization still making headlines in women’s health

Thu, 08 Mar 2012 10:45:47 GMT

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.