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Articles from 2014 In June

FDA Approves Edwards ClearSight Noninvasive Blood Monitor

Edwards ClearSight
Edwards' ClearSight noninvasive blood monitor (Courtesy Edwards Lifesciences)

Edwards Lifesciences (Irvine, CA) has announced that it has received FDA 510(k) approval for its ClearSight noninvasive monitor that, in conjunction with the company's EV1000 clinical platform, provides blood volume and blood flow information for patients at moderate or high risk of post-surgical complications, for whom invasive monitoring would not be used.

Edwards says the ClearSight system is the most advanced noninvasive monitor of its kind, The system incorporates a finger cuff on the outside of the finger and software elements that have been used for the noninvasive monitoring of the blood pressure of astronauts in space.

The inflatable finger cuff provides access to key hemodynamic parameters, including Stroke Volume (SV), Stroke Volume Variation (SVV), Cardiac Output (CO), Systemic Vascular Resistance (SVR), and Continuous Blood Pressure (cBP).

The ClearSight system automatically provides up-to-the-minute information without inserting anything into the body. The system thus extends the benefits of hemodynamic optimization, or proper fluid administration and balance within a patient's organs and tissues, to a broader patient population that could benefit from close monitoring, but may not receive it without a noninvasive option.

"Proper intraoperative management of moderate and high-risk surgery patients is critical to help reduce the risk of post-surgical complications," said Julie K. Thacker, MD, surgical oncologist at Duke University Hospital. "Studies have indicated that patient outcomes are improved through monitoring and management of vital hemodynamic information through hemodynamic optimization protocols."

Refresh your medical device industry knowledge at MEDevice San Diego, September 10-11, 2014.

The EV1000 clinical platform allows clinicians to set specific color target ranges to clearly indicate patient status; and to choose parameters, alarms and targets to align with hemodynamic optimization protocols to meet precise patient monitoring needs. Edwards cites clinical data that demonstrate noninvasive ccNexfin BP technology obtains mean arterial pressure values comparable to invasive monitoring with the advantage of continuous measurement.

Several studies have shown the ability of this noninvasive technology to measure not only absolute cardiac output values, but also reliably track real-time changes in continuous cardiac output (CO). The ClearSight system provides valuable hemodynamic insight into an expanded patient population, allowing clinicians to make more informed decisions about volume administration in moderate to high-risk surgery.

The ClearSight system has also been approved in CE Mark countries.

Stephen Levy is a contributor to Qmed and MPMN.

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A Diabetes Game Changer? FDA Approves Inhalable Insulin

Diabetes treatment in the United States could be due for some radical change now that the FDA has approved MannKind Corp.'s Afrezza fast-acting, inhalable insulin. Valencia, CA-based MannKind announced the approval late last week. Type 1 diabetics would still need shot of long-acting insulin, but could supplement them with use of an Afrezza inhaler, while type 2 could potentially get insulin without injections. "We believe that Afrezza's distinct profile and non-injectable administration will address many of their unmet needs for mealtime insulin therapy, and has the potential to change the way that diabetes is treated," MannKind CEO Alfred Mann said a news release.

Afrezza hopes that its inhalable insulin product will be a gamechanger for diabetics. (Image courtesy Afrezza).
The big open question is how much the Afrezza approval will affect the diabetes care market when it comes to Medtronic, Johnson & Johnson and other companies' work on "smart" insulin pumps outside the body that could act as an artificial pancreas, adjusting insulin levels automatically based on glucose sensor readings and computer algorithms that anticipate the user's behavior. Could the smartest, and cheapest, insulin therapy of all simply be to use an insulin inhaler before a big meal? The FDA approval comes a few months after Mannkind's drug-and-inhaler combination device received the go-ahead from FDA's Endocrinologic and Metabolic Drugs Advisory Committee. The committee's vote at the time was a bit of a surprise because of concerns that long-term exposure to inhalable insulin might potentially cause lung cancer, according to The New York Times.
Refresh your medical device industry knowledge at MEDevice San Diego, September 10-11, 2014.
Even now, the treatment is not recommended for smokers. And the FDA is requiring a Risk Evaluation and Mitigation Strategy to ensure that the benefits of Afrezza outweigh the potential risk of acute bronchospasm in patients with chronic lung disease. And The New York Times has noted that Pfizer had an inhaled insulin called Exubera that flopped in the past decade, with competitors including Novo Nordisk and Eli Lilly abandoning development efforts.

Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker.

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Learn Google's 3 Principles for Wearables Design - 3

 Find the Best Approach

“A new form factor means building new types of software,” Alex Faaborg, staff designer at Google, told the audience.
For Google the way to approach wearables is in two aforementioned new modes of interaction – voice and context, both of which it is releasing APIs on for developers. Faaborg used the example of surgeon in the OR. The surgeon reaches out his hand and, without even having to look, is handed a tool by a nurse. Faaborg says users want wearables to function in the same way. “Users expect the app to be there.”
Developers of wearables and software should approach design by looking closely at how to provide the best, most seamless experience for users. It's a fine line to draw for health apps. Someone with a chronic condition wants to be assisted in managing it, but not necessarily reminded of it day in and out. From the app side Faaborg said this comes with ensuring users don't have to worry about anything except “subscribing to an intent.” Simple voice commands like “Ok Google what's my heart rate?” allow for much faster and less invasive user interactions when possible.
Factor in context and there is even more potential for wearables to continuously work in the background for users. Faaborg pointed to LynxFit an app for Google Glass as an example. The app uses motion sensors to watch you do a workout and works like a personal trainer- it can be set to activate at a specific time or even whenever you enter a particular location. Similarly a nutrition app could use location tracking to detect what restaurant you're at and suggest meal options based on your diet. No need for diabetics or people with allergies to nag the waiter.
Pointing to Android Wear as an example, Faaborg said that the “user interface is is not that complicated. This isn't about sketching a variety. It's about what the contextual trigger conditions are.” and thinking about the world and what the user needs...It's really important in thinking about these wearable applications to think about the world.”
Watch Google's full “Designing for Wearables” seminar from Google I/O below:

Back to Beginning

Learn Google's 3 Principles for Wearables Design - 2

Consider User Context

Even as devices cross over into both – a hospital will never be a home.
Emmet Connolly, a designer at Google, believes the most effective apps will follow Google's dictum that computing must fade into the background and “have the right information appear automatically based solely on context.” From a health and medical perspective this means having a wearable device automatically capable of sensing when a user is active versus sedentary, at a certain location such as work, home, or even outdoors, and even whether a user is in an emergency situation.
Connolly points to an Android Wear running app as an example. Rather than having a user active an individual app, a context-sensitive wearable could know when you start running, based just on inputs of time, location, habits and movement, and start run up your tracking apps – and even playing music - automatically.
As sensors for devices grow more robust, Connolly feels this functionality will be easily obtainable. “The real interesting thing happens when we take the combined total of all this sensor data and put it together into one single rich picture of the user's situation.”
“So as developers we can look at this and say 'how can we present the user with useful information that can help them?' ” Connolly said. He again encouraged developers to think about simplicity in develiing this information and stressed the importance of “one simple, clear piece of info showing up at the time – prioritized by importance.” The Android Wear and Google Glass interfaces, for example will allow users to arrange and rank simple screens so that users can dictate what information is important to them. Again this becomes important in a medical perspective in thinking of what health metrics to deliver and what would be most helpful for a particular patient.  

Learn Google's 3 Principles for Wearables Design - 1

 Realize a Wearable is Not a Computer or Phone

You computer is filled with dozens, if not hundreds of programs and apps. Your phone is perhaps filled with fewer but can be just as cluttered. The different is in the user experience. While it may take several clicks or typing a command to access a function or program on your desktop your phone gets you there in a few swipes and touchscreen presses.
Bob Ryskamp, a product designer at Google, told the audience that a wearable needs to do better than both of these.“That same gorgeous phone interface that works so well when I'm sitting and standing doesn't work as well when I'm active.” Rykamp used the example of someone trying to monitor their fitness while riding a bike, but it's easy to see this same type of application carry over into medical applications. A doctor or surgeon will likely need both hands free and a patient in an emergency situation may not be able to access a device very quickly.
The solution Ryskamp says is both in simplifying the interface and how users control the device. “We believe natural language speech. . . is going to make interacting with wearable even easier a faster than phones and desktops,” he said.
When it comes to interfacing with wearables developers would be best served by following the KISS model (Keep it Simple, Stupid). Ryskamp encouraged developers to “think very carefully about what's that individual short, experiecne that people want to have and break up that big app into individual flows.” Breaking things down into small functionalities allows developers to create simple commands and interactions for users. “Then you can design and craft and individual voice action just for that flow,” he says.  

Learn Google's 3 Principles for Wearables Design

Learn Google's 3 Principles for Wearables Design

So you want to make a wearable device? While Google Fit isn't promising anything Apple's HealthKit hasn't Google is hoping that it's Android Wear operating system will give developers and users new and easier functionalities when it comes to wearable devices. But developers should be cautious before they just slap another wrist-worn device or sensor onto a user. Some Google staffers were on hand at the Google I/O conference to share some advice for developers looking to create wearable devices for Android-based platforms and offered some sound sound principles and ideas for those looking to create wearables for medical and health applications to consider.

[Images via Google]


-Chris Wiltz, Associate Editor, MD+DI

Many Knee Replacements Called into Question

In a note of caution for orthopedic device companies, a new study suggests that more than a third of U.S. knee replacements might be unnecessary. The study-- led by Daniel Riddle, PhD, at the Department of Physical Therapy at Virginia Commonwealth University in Richmond--used an appropriateness classification system developed and validated in Spain. It them applied the system to participants enrolled in the Osteoarthritis Initiative--a prospective 5-year study funded in part by the National Institutes of Health (NIH), according to a news release from Wiley, the study's publisher. Among the 175 subjects who underwent total knee replacement surgery, more than a third of the procedures were deemed inappropriate, which meant the patients did not have a level of knee pain or loss of functionality to warrant the procedure, according to Riddle and his colleagues. And it was not conclusive whether knee replacements were appropriate for another fifth of the study subjects. Riddle and colleagues' study recently ran in Arthritis & Rheumatology, which Wiley publishes on behalf of the American College of Rheumatology. If the NIH study participants Riddle studied are truly reflective of the general U.S. population, then more than 200,000 people a year could be undergoing inappropriate knee surgeries, since the federal government's Agency for Healthcare Research and Quality counts more than 600,000 knee replacements in the U.S. annually. The median age among the 175 NIH study subjects was 67, and 60% were women. Wiley's news release quotes Jeffery Katz, MD, of the Orthopedic and Arthritis Center for Outcomes Research at Brigham and Women's Hospital in Boston, calling for an update to the criteria used to determine which patients are good candidates for total knee arthroplasty. Making sure that knee replacements and other orthopedic procedures only take place when needed matters, because a wider and younger swath of the population is utilizing such devices, potentially exposing themselves to the risks of medical device complications.

Refresh your medical device industry knowledge at MEDevice San Diego, September 10-11, 2014.
A Star Tribune of Minneapolis analysis last year found that that middle aged Americans, 45- to 64-years-old, have the fastest growth rates when it comes to implants of knee and hip devices, not to mention pacemakers and defibrillators for the heart.

Chris Newmarker is senior editor of MPMN and Qmed. Follow him on Twitter at @newmarker.

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Wolves Close In as Allergan Defends against Hostile Takeover

Paulson & Co., a hedge fund led by John Paulson, has reportedly scooped up more than 6 million shares of hostile takeover target Allergan, giving the fund more than 2% of the company.

The New York Post says that regulatory filings show that New York City-based Paulson & Co. already owns more than 1 million shares of Valeant Pharmaceuticals and the new position is expected to be in support of the Valeant-led hostile takeover. According to Fidelity, Valeant CEO Michael Pearson has said he was "delighted" at the disclosure of Paulson & Co.'s stake in Allergan.

Valeant, which is known for running acquisitions in a manner that maximizes immediate profit-making potential at the expense of R&D and future product development, had offered about $53 billion for the maker of Botox and other lesser known drugs. As we recently reported, that offer was rejected by Allergan's board of directors, which led to the announcement that Valeant would be taking its offer directly to Allergan's shareholders.

This latest twist in the saga, first reported by Reuters, will rank Paulson & Co. among the 15 largest Allergan shareholders, according to Thomson Reuters shareholder data as of March 31. Valeant needs support from at least 25% of Allergan shareholders in order to proceed with its plan to call a special meeting to elect new directors to Allergan's board who could vote in support of Valeant's offer, thus paving the way for a takeover of the company.

According to Reuters, Allergan and Pershing Square Capital Management, which is led by activist investor William Ackman, have agreed that special meeting will not trigger Allergan's so-called "poison pill" measure, the companies said on Friday. Ackman is said to hold about 9.7 percent of Allergan, which, combined with the more than 2 percent held by Paulson, could put the raiders within striking distance of the required 25 percent.

Refresh your medical device industry knowledge at MEDevice San Diego, September 10-11, 2014.

Reuters reports that Pershing Square had filed suit in Delaware earlier this month seeking confirmation that soliciting proxies to call a meeting and replace board members would not trigger the pill. "The rights agreement was drafted in a manner to allow Allergan stockholders to seek to call a special meeting, and the stipulation simply makes it clear how the bylaws and the rights agreement work together," Allergan spokeswoman Bonnie Jacobs said in a statement emailed to the news service.

Clive Minchom, writing for Jewish Business News, says that the agreement to not pursue the suit "also added the important proviso that shareholders agreeing to call for such a meeting must not already have made a choice to commit to tender their shares to the bid--which certainly would trigger the poison pill."

Stephen Levy  is a contributor to Qmed and MPMN.

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Research Shows Hydrogels Help Stem Cells Repair Bone

When stem cells are used to repair bone tissues, many of them wind up migrating away from the repair site. Now researchers at the University of Rochester in New York have developed a method of keeping them in place, resulting in faster and better tissue regeneration. 

University of Rochester Hydrogel Bone Stem Cells
Representation of hydrogel polymers (straight lines) trapping stem cells (light-colored figures) and water (blue). (Courtesy Michael Osadciw/University of Rochester)

The technique, which is similar to that already used to repair other types of tissue, has never before been tried on bone, according to the researchers.

"Our success opens the door for many-- and more complicated--types of bone repair," said Danielle Benoit, PhD, assistant professor of biomedical engineering. "For example, we should now be able to pinpoint repairs within the periosteum - or outer membrane of bone material."

The researchers describe their experiments in "Degradable Hydrogels for Spatiotemporal Control of Mesenchymal Stem Cells Localized at Decellularized Bone Allografts"--scheduled for publication in Acta Biomaterialia.

The key to their success lies in encasing the stem cells in hydrogels. Benoit believed  hydrogels would allow the stem cells to finish the job of initiating repairs. The research team tested this hypothesis by transplanting cells onto the surface of mouse bone grafts and studying the cell behavior both in vivo and in vitro.

The hydrogels mimic the natural tissues of the body but are specially designed to degrade and disappear before the body interprets them as foreign bodies and begins a defense response that could compromise the healing process, an additional feature that's vital to the repair process.

Benoit and her team were able to manipulate the time it took for hydrogels to dissolve by modifying groups of atoms--called degradable groups--within the polymer molecules. By introducing different degradable groups to the polymer chains, the researchers were able to control how long it took for the hydrogels to degrade.

Refresh your medical device industry knowledge at MEDevice San Diego, September 10-11, 2014.

Benoit believes degradable hydrogels show promise in many research areas. For example, she says, it may be possible to initiate tissue regeneration after heart attacks without having a patient undergo difficult, invasive surgery. She admits, however, that a great deal of additional research will be required to arrive at this point.

Stephen Levy  is a contributor to Qmed and MPMN.

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Post Medtronic-Covidien Mega Deal, Small Deals Continue With Stryker Buying SBI

 Post Medtronic-Covidien Mega Deal, Small Deals Continue With Stryker Buying SBI

Stryker announced Monday that it is buying Small Bone Innovations, a Morrisville, Pennsylvania maker of upper and lower extremity products for $375 million in cash.

It’s a small acquisition helping Stryker access the high-growth ankle market, wrote Richard Newitter, an analyst with healthcare investment bank Leerink Partners, in a note to investors Monday.

After the mega deal marrying Medtronic and Covidien was announced earlier two weeks ago, several analysts felt that small, tuck-in deals would be less important as companies sought larger deals to effectively contend with the ramifications of the Affordable Care Act.

This is how Newitter’s colleague Danielle Antalffy viewed the medtech M&A sector after Medtronic’s bold acquisition of Covidien was announced:

With this acquisition now underway, mid-cap companies that were previously considered consolidators may have to revisit their M&A strategy and consider larger transactions in order to compete more effectively. As well, the same mid-cap companies could also now be in play as assets for a larger acquirer as consolidation moves toward increased scale. While we think small-cap acquisitions are still in the cards over time, for now they may take a backseat as larger megadeals are announced for strategic reasons beyond growth (i.e., tax inversion, freeing OUS cash).

Another analyst echoed Antalffy’s thoughts:

“While the sector will move higher on the prospects of further M&A, we believe the recent [Zimmer-Biomet] announcement and now the [Medtronic- Covidien] announcement, suggests that the larger-cap companies are now thinking about bigger deals, and not tuck-ins,” wrote Glenn Novarro, in a research note following the announcement from Medtronic. “In our opinion, this means small-cap medtech companies in cardio, spine, and extremities may no longer be targets over the near to intermediate term.”

The Stryker acquisition of Small Bone Innovations appears to be directly contradicting this thesis.

The deal is miniscule - $375 million compared with the gargantuan price tag Medtronic will pay - $42.9 billion or even the $13.35 billion Zimmer intends to pay to buy Biomet.

Yet, the rationale for the deal seems to be pretty solid. Small Bone Innovations brings a total ankle replacement product to Stryker, something it did not have previously, Newitter wrote. 

“We believe the transaction represents a logical move to expand the company's portfolio in one of its fastest growing franchises (foot & ankle) and perhaps most importantly gives SYK a product to tap into the underpenetrated and rapidly growing total ankle replacement (TAR) market, an ~$100M WW market opportunity that is growing in the mid-to high-teens,” he said in his research note.

Small Bone Innovations also makes finger, wrist, and elbow products and total sales were $48 million in 2013, according to a Stryker press release. That meams Stryker is paying a 7.8 times 2013 sales to buy Small Bone Innovations.

Not all agreed that tuck-in acquisitions would take a hiatus as larger deals flood the market following Medtronic’s purchase of Covidien more than two weeks ago.

“I don’t think the level of tuck-in acquisitions is going to change,” said Robert “If I were the small guy and I saw half a dozen potential acquirers a year ago and there’s only four now and the number is only going to get smaller, I think I’d want to negotiate sooner than later.

[Photo Credit: user Cimmerian]

-- By Arundhati Parmar, Senior Editor, MD+DI