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How Will Patients Be Affected By Medtronic's TAVR Battle With Edwards?

How Will Patients Be Affected By Medtronic's TAVR Battle With Edwards?

A federal appeals court granted Medtronic a temporary stay on an injunction that would have prevented the device maker from selling its CoreValve Transcatheter Aortic Valve Replacement system in the U.S.

Some analysts have said that injunctions being issued in the U.S. preventing sale of products are a rare phenomenon. While it has a temporary reprieve, Medtronic now has to convince the Federal Circuit Court of Appeals that its products do not infringe upon the patent of rival Edwards Lifesciences and that the injunction was improperly issued. How does this legal case affect patients.

The Minnesota company only has a few months to persuade the court that the injunction was improperly issued. By Medtronic’s own request, the court has agreed to an expedited schedule. May 12 is the deadline by which Medtronic has to file its opening brief, followed by an opening brief from Edwards by June 12. June 19 is the deadline for a reply from Medtronic. Oral arguments could occur as soon as this summer, said Glenn Novarro, an analyst from RBC Capital Markets in a research note Monday, where he also speculated about possible scenarios regarding the outcome of the case.

One scenario is Medtronic loses the case and the injunction goes into effect. That would mean that Edwards would still be market leader in the TAVR space up until 2016. Edwards has sought extensions of the patent that it has so far successfully argued Medtronic has infringed. That patent originally expired in 2012 but Edwards has been getting annual extensions. The California company has requested a permanent extension till 2016. That would mean Medtronic’s CoreValve product would not be available for sale in the U.S., except in clinical trials, for another two years.

If Medtronic doesn't settle and the appeals court agrees with the lower court that Medtronic has wilfully infringed Edwards' patent - something that Edwards' CEO Michael Mussallem has said Medtronic did as soon as it acquired CoreValve in a recent letter to customers and partners - patients will be left with only one commercially available TAVR system.

That is Edwards' Sapien system and while the product is novel, safe and effective, it hasn't proved as Medtronic's CoreValve has done that it is clinically better than traditional open heart surgery for patients with severe aortic stenosis. Michael Weinstein, a JPMorgan Chase analyst reported in a recent analyst report that cardilogists were shocked by the initial news that a judge had ecided that Medtronic's device should not be sold in the U.S. market. 

Medtronic's loss,this time in the federal appeals court would ironically appear to be a loss for U.S. patients as well. 

However, not everyone sees it this way. An analyst who declined to be quoted on the record said that the CoreValve and Sapien are very similar and he doubts patients will be affected. 

"In head to head studies, Sapien has performed slightly better," he said in an email. 

That was likely a reference to a small, European study - CHOICE - which pitted Sapien's next-generation product of a lower profile against Medtronic's CoreValve.

In the short term, the courts may decide that only one company can sell a TAVR device in the U.S. and in doing so, make the choice for patients and physicians. From a clinical perspective, which is the better product is something that is more complicated.

"“Continued efforts at understanding the risks and benefits of TAVR particularly in relation to patient characteristics and long-term outcomes are imperative for continued progress and refinement of these revolutionary devices," said said Dr. E. Murat Tuczu and Samir Kapadia in an editorial in the Journal of the American Medical Association published earlier this month.  Additional rigorous randomized trials like the CHOICE trial will provide the quality of evidence necessary to ensure optimal use and optimal patient outcomes from TAVR.”

[Photo Credit: user THEPALMER]

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

FDA May Speed Up Access for Some Medical Devices

The U.S. Food and Drug Administration is proposing a new program that could provide seriously ill patients with earlier access to high-risk medical devices. The proposed Expedited Access Premarket Approval Application for Unmet Medical Needs for Life Threatening or Irreversibly Debilitating Diseases or Conditions ("Expedited Access PMA" or "EAP") program would cover medical devices meant to treat or diagnose patients with serious conditions whose medical needs are unmet by current technology, the FDA said Tuesday. The proposed EAP program comes at the same time that the FDA has been collaborating more closely with medical device industry leaders through the Medical Device Innovation Consortium, which Minnesota-based trade group LifeScience Alley helped roll out at the end of 2012. The FDA cautions that the EAP is not a new pathway to market, but rather a collaborative approach to facilitate product development under existing regulatory structures. Other existing device programs have concentrated on reducing the time for the premarket review, while EAP also seeks to speed up product development. If a company's medical device fell under the program, there would be earlier and more interactive engagement with FDA staff. Such engagement would include involvement of senior management and a collaboratively developed plan for collecting the scientific and clinical data to support approval. "The program allows manufacturers to engage early and often with the agency. We expect most devices that enter this program will be in the pre-clinical trial phase," Jeffrey Shuren, M.D., director of the FDA's Center for Devices and Radiological Health, said in a news release. To fall under EAP, devices would have to be intended to treat or diagnose a life-threatening or irreversibly-debilitating disease or condition. There will also have to be no approved alternative, or the device would have to be a breakthrough technology, or it would have to offer a significant, clinically meaningful advantage over existing technology, or its availability would simply have to be in the patients' best interest.

Refresh your medical device industry knowledge at MD&M East, June 9-12, 2014 in New York City.
The program actually builds on the FDA's Innovation Pathway pilot, which the FDA launched in 2011, and the FDA's experience with expedited review programs for pharmaceuticals, including Accelerated Approval and Breakthrough Therapies. "To assure that a device is safe and effective and provide timely patient access to breakthrough devices, it's critical to get the right balance between pre-market data collection and post-market data collection," Shuren said.

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

Google Working on Embedding a Camera in a Contact Lens

Google, apparently not content with its Glass device, is now embedding a tiny camera in a contact lens, according to a recently disclosed patent application. Essentially, wearers will not have to ask, "Do you see what I see?" They'll be able to show them.

This is not the first improvement to contact lenses that Google has proposed. Back in January  the search giant unveiled a contact lens with an embedded glucose meter that could actually be useful for diabetics.

The 'smart' part of this new lens will allow it to process image data and perform other functions locally or via a remote device. A patent application filed in 2012, recently published by the US Patent and Trademark Office, describes a contact lens that includes an embedded circuit, camera, and sensor. The control circuit, the application states, could be wired or linked wirelessly to the camera and sensor. The sensor could be a light sensor, pressure sensor, temperature sensor, or electrical field sensor.

Google Contact lens

Google's smart contact lens may include camera, glucose meter, or both (Courtesy Google Inc.)

Google says that the lens could take raw image from a contact lens, process it and relay what it sees to a blind wearer via a different sense--perhaps an audio warning that there is a car approaching an intersection, for example. It might also be possible to build in a zoom capability, Google says. Facial recognition software hinted at could also allow cops to compare the faces of passersby with a database of mugshots.

In a parallel development, the patent application for the contact lens mounted glucose meter has also surfaced, and it would seem that the company is moving forward with the development of this technology.

Refresh your medical device industry knowledge at MD&M East, June 9-12, 2014 in New York City.

But given Google's known willingness to make use of the data it collects, the Washington Post's Hayley Tsukayama spoke with Joseph Lorenzo Hall, chief technologist at the Center for Democracy & Technology, who was briefed on the lens by Google's people. Hall said that Google had assured him that the data would not be added to the company's data banks of personal information gathered from its other services.

"The data will never hit Google's servers," he told Tsukayama. "That's a forward-thinking affirmative claim that they're making. That is important."

Given the sensitive nature of the data, Hall said, Google has also said it will make sure any data transferred from the lens cannot be manipulated -- something that could have potentially fatal consequences if patients inject the wrong amount of insulin.

dGoogle contact lens patent
A patent diagram showing Google's smart contact lens with an integrated camera.

Stephen Levy is a contributor to Qmed and MPMN.

3-D Printed Blood Recycling Machine Reduces Cost of Blood Transfusions

3-D Printed Blood Recycling Machine Reduces Cost of Blood Transfusions

The Hemosep incorporates several 3-D printed components. [image source: Statasys]

Brightwak Ltd, makers of the Hemosep, a blood recycling machine for transfusion patients, says that using 3-D printing cut its prototyping costs by 96%. The Hemosep is an autotransfusion device that collects and recycles blood that has been spilled during major surgeries. Blood collected from a surgical site or left in a heart-lung machine is placed into a bag that features a polycarbonate membrane to soak up unwanted plasma while preserving blood cells, and into a mechanical agitator that keeps the blood from settling. Since the patient's own blood is used this whole autotransfusion process reduces the amount of donor blood required and the problems associated with transfusion reaction.

Several parts of the prototype device, which has received a CE Mark in the UK, were 3-D printed using Stratasys Dimension 1200es printers including the main filtration and cooling systems. The final device is made of metal but Brightwake says that using 3-D printing to prototype the parts allowed for functional, but far less expensive testing. "Previously we had to outsource the production of these parts which took around three weeks per part," says Steve Cotton, Brightwake's Director of Research and Development. "Now we're 3-D printing superior strength parts overnight, cutting our prototyping costs by 96% and saving more than £1,000 for each 3-D printed model. "3-D printing has not only enabled us to cut our own costs, it has also been crucial in actually getting a functional device to clinical trials.”
According to the company, the Hemosep has performed successfully in over 100 open-heart surgeries performed in Turkey. Further patient trials are now underway in the UK.
Hemosep is currently seeking FDA approval.
The MD&M East Conference will be hosting sessions on "Accelerating Speed to Market Through Effective Prototyping and 3-D Printing" June 11, 2014.

-Chris Wiltz, Associate Editor, MD+DI

Mainstay Medical Plans IPO to Fund Back Pain Device

Mainstay Medical, an Irish back pain device company with Minnesota roots, plans to raise up to EUR30.4 million ($41.9 million) in an IPO on Euronext Paris. The Dublin-based company plans to use the money to further regulatory approval and commercialization efforts around ReActiv8, a small implanted device that stimulates the nerves responsible for contracting the key muscles that stabilize the lower back. Mainstay Medical said in its prospectus that it plans to sell up to 851,175 shares at a price of EUR20 to EUR27 ($27.59 to 37.25) per share, which would raise EUR17.0 million to EUR23.0 ($23.5 million to $31.7 million). If demand around the April 29 offering grows, the company increase the offering to more than 1 million shares, bringing in EUR22.5 million to EUR30.4 million ($31.0 million to $41.9 million). Twin Cities serial medtech entrepreneur Dan Sachs, MD, founded the company in 2008 after filing a patent related to the ReActiv8 concept. Sachs, who remains a director, helped bring in experienced device entrepreneur Peter Crosby in 2009. Crosby moved the company from Minneapolis to Dublin in 2012 amid support from Irish backer Fountain Healthcare Partners. Besides Fountain and Sachs, other major shareholders include medical device giant Medtronic, Sofinnova Capital, Capricorn Health-Tech Fund NV, and Seventure Partners Managed Funds.

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

FDA Stops Issuing NHRIC and NDC Codes for Devices

FDA Stops Issuing NHRIC and NDC Codes for Devices

By Jim Dickinson

FDA says that to conform to change made under the Unique Device Identification (UDI) final rule, it has stopped issuing National Health Related Items Code (NHRIC) and National Drug Code (NDC) labeler codes to manufacturers for use with medical devices.

Previously, a notice says, manufacturers and distributors wanting to use the NHRIC system for unique product identification could apply to the agency for a labeler code.

Use of the NHRIC and NDC system for medical devices is being phased out over a time period that corresponds with the compliance dates for UDI requirements, the notice says. On the date that a medical device must have a unique identifier on its label, any NHRIC or NDC labeler codes assigned to the device are rescinded and may no longer be provided on the device label or package. For devices not required to have a UDI on their labels, any NHRIC or NDC code assigned to them are rescinded and may no longer be present on the device label or package after 9/24/18.

Labelers who want to continue to use a previously issued NHRIC or NDC labeler code until the compliance date must submit their request to FDA by September 24, 2014, and receive approval for continued use.

Jim Dickinson is MD+DI's contributing editor.

4 MedTech Business Takes from the Top

From the debate over the effects of an unusually nasty winter to the reining in of U.S. healthcare spending, there were plenty of insights to be gleaned from the recent discussions major medical device company CEOs had with analysts. Here four highlights from last week's earnings calls, culled from transcripts on Seeking Alpha:

St. Jude Medical: $1.36 Billion in Q1 Sales

In true Minnesota fashion, St. Jude Medical's CEO Daniel J. Starks would have nothing of speculation that the especially cold winter may have hindered St. Jude and other device company's business:
"We have a philosophical bias against blaming the weather for sales in a quarter, ... so that's why we didn't mention it in our prepared remarks. ... But the weather probably had an impact on sales in some markets. There was quite a bit of weather and snow days and lack of selling days compared to the same quarter a year ago, but we don't really know how to model that, and we don't focus on it, and we, as an organization, we really don't accommodate excuses internally and we don't want to make excuses externally. It probably was a factor, but we aren't able to quantify it and won't rely on it as a reason."

Johnson & Johnson: $18.1 Billion in Q1 Sales

Dominic Caruso, JNJ's CFO and VP, Finance, was "very pleased with our strong start to 2014" and believes his company is "well positioned for continued growth in this dynamic healthcare environment." Caruso says the company has noticed fewer surgical and lab procedures in the United States:
"What we saw in the US markets ... was a ... year-over-year decline in the rate of utilization, particularly hospital admissions, as well as lab procedures. So, these have been trending now for the past year or so at minor downticks in the quarter -- year-over-year growth in the quarter, or depression in utilization from the prior year. So we saw that continue in the first quarter."
The orthopedics space was a bit more nuanced:
"With respect to orthopedics in particular, we did expect ... that the higher utilization in the fourth quarter was a result of seasonality, primarily related to the health plans and also probably some influence from the Affordable Care Act rush to get coverage and some ...confusion over what was happening in the marketplace. So in particular, the orthopedic trends did slow down in the first quarter compared to the fourth quarter. And we saw this very same phenomenon a year ago. So, it's now become quite a seasonal business from that perspective that we see a real uptick at the back end of the year and then a slowdown in the early part of the year."
And unlike Starks, Carsuso appears to have been fine blaming the weather a little:
"The only other thing I would say that in the medical device business more broadly we did see some softer trends in elective procedures. We think in the US that's probably due to the severe winter conditions, so we don't have any exact data on that fact but anecdotally that's what it appears, [the bad weather] has impacted utilization rates in the first quarter."
"Johnson & Johnson is best positioned in medical devices ... given what's happening in the market with respect to hospitals and ... the Affordable Care Act and the accountable care organizations," Caruso said. "We're working to not only remain the largest player in medical devices, but to take advantage of that position in the hospital setting with respect to providing total solutions to the marketplace."

Baxter International: $3.95 Billion in Q1 Sales

Baxter's chairman and CEO Bob Parkinson was upbeat about his company's $4 billion acquisition last year of Swedish dialysis products manufacturer Gambro AB:
"It allows us to participate in a leadership role in a large global markets that we believe will grow in the 5% to 6% range long-term. And so, the acquisition of Gambro, the expansion of our presence augmenting our PD business to address treatment of end-stage renal disease a significant long-term growth platform for the newly defined medical products business, but I think you all understand that. Within the traditional medication delivery business ... our plans are to intensify focus in those product categories that are higher growth than higher margins. So, anesthesia would be one; parenteral nutrition would be another. Also, there continue to be opportunities to improve margins in our core global IV business in terms of manufacturing efficiencies, productivity, supply chain productivity, and the like."
Refresh your medical device industry knowledge at MD&M East, June 9-12, 2014 in New York City.

Abbott Laboratories: $5.24 Billion in Q1 Sales

With better-than-expected results, it's not surprising that Abbott Labs execs were decidedly upbeat throughout their conference call. About the only dark cloud mentioned on Abbott's horizon is the decline of their diabetes care. "In our global diabetes business, we continue to forecast a low double-digit decline on an operational basis," said Miles White, chairman and CEO, laying the blame on the "carryover effect from implementation of the CMS competitive bidding program for Medicare patients" last year. That the company is focusing on improving operating margins was a recurrent theme. White also said: "The underlying fundamentals of everything I'm looking at look solid to me. I don't see any trends or anything that are concerning me yet."

Stephen Levy is a contributor to Qmed and MPMN.

Senior editor Chris Newmarker contributed to this story. Follow him on Twitter at @newmarker.

15 Highest-Paid MedTech CEOs In the U.S. (#13)


Vincent A. Forlenza, Chairman, President and CEO, Becton Dickinson & Company

[Photo Adapted from Becton Dickinson YouTube Video]

In 2013, Forlenza made $9.2 million, which was 2.5% less than what he made the previous year.


15 Highest-Paid MedTech CEOs In the U.S. (#12)


Timothy M. Ring, Chairman and CEO, C.R. Bard 

 In 2013, made $9.4 million, a 6.8% increase from his compensation the previous year.


Drool, Baby, Drool! Saliva May Power Oral Devices

A saliva-powered fuel cell. (Courtey Penn State University)

While (so far) it produces less than one microwatt of power, researchers have figured out how to harvest electricity from human saliva.

Using the oxygen in the air as the cathode and graphene as the anode, scientists at the King Abdullah University of Science and Technology (Thuwal, Saudi Arabia) and Penn State University (State College, PA) have harnessed bacteria into a 25-?l microbial fuel cell (MFC).

Although saliva does not have the type of bacteria necessary for the fuel cells, it can be inserted in the device by a manufacturer. As the bacteria digest organic material in the saliva, they give off electrons that are deposited on the graphene anode for harvesting. The researchers said they had tried using a carbon cloth anode, but found that graphene was 40 times more efficient.

Refresh your medical device industry knowledge at MD&M East, June 9-12, 2014 in New York City.

Bruce Logan, PhD, Evan Pugh Professor and Kappe Professor of Environmental Engineering at Penn State, credited the idea to researcher Justine E. Mink PhD, according to a story on the Penn State News (PSN) website. "The idea was Justine's because she was thinking about sensors for such things as glucose monitoring for diabetics and she wondered if a mini microbial fuel cell could be used," Logan said.

Logan told PSN reporter A'ndrea Elyse Messer that air cathodes have not previously been tried because if oxygen can get to the bacteria, they will use the oxygen and do not produce electricity.

"We have previously avoided using air cathodes in these systems to avoid oxygen contamination with closely spaced electrodes," said Logan. "However, these micro cells operate at micron distances between the electrodes. We don't fully understand why, but bottom line, they worked."

The research, "Energy Harvesting from Organic Liquids in Micro-Sized Microbial Fuel Cells," was published in Nature's NPG Asia Materials journal. The scientists posit that one potential use for their power source might be as a fertility signaling device, small enough to be attached to a tooth, that could predict a woman's ovulation from changes in her saliva's electrical conductivity, which is known to plummet five days before ovulation.

Stephen Levy is a contributor to Qmed and MPMN.