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New Injectable Gel Could Repair Weakened Hearts

Patients who have suffered a heart attack may have a new form of therapy through injectable hydrogels that can repair weakened tissue and possibly prevent future heart failure.

Kristopher Sturgis

ACS Penn Hydrogels HeartModified injectable hydrogel polymers could provide mechanical support to damaged areas of the heart, according to University of Pennsylvania research presented last week at a meeting of the American Chemical Society.

Jason Burdick, Ph.D., professor in bioengineering at Penn and leader of the study, thinks these gels could be a difference maker when it comes to the damage heart attacks can leave behind.

"After a heart attack the tissue undergoes a series of events including inflammation and matrix degradation, termed left ventricular remodeling," he says. "This changes the size and composition of the heart. If the heart attack is severe, this may even lead to heart failure. Injectable hydrogels can provide many therapeutic benefits, including the delivery of cells and drugs for repair. In this approach, the hydrogels help to reduce stresses in the heart wall, which can minimize some of the damage to the heart and maintain function."

Structural Heart Opportunities and Challenges

TAVR and TMVR are among the hottest technologies in medtech right now. Learn what it takes to innovate in the structural heart space at the MD&M Minneapolis conference on September 21. Qmed readers get 20% off with promo code Qmed16.

According to the American Heart Association more than 750,000 people experience heart attacks in the U.S. each year, and more than 5 million patients are living with heart failure.New treatments for heart failure continue to crop up, but many serve as a stopgap solution. Burdick says that these new hydrogels contain unique mechanical properties that can be controlled to promote heart support and improve therapy results.

"These hydrogels are comprised of a polymer hyaluronic acid, which is used in numerous medical therapies and in cosmetics," Burdick said. "They are modified with various chemical groups to permit the formation of hydrogels, and to control their properties. These properties are important to permit injection of the material and to control the mechanical properties. Our work has shown that hydrogels that have increased mechanics improve the results of therapy."

The new hydrogel therapy was also designed to provide an alternative to patients whose only option is surgery to repair damaged heart tissue or to remove scar tissue. In a recent experiment, Burdick and his colleagues tested the gels on sheep and found that the gel limited the formation of scar tissue while also limiting the thinning of the heart's walls. They also found that the gel limited enlargement of the heart, which can also reduce blood loss from the mitral valve--all of which help maintain the heart's ability to efficiently pump blood and stave off heart failure.

As the group moves forward with their research, the next step is to finalize the hydrogel formulation and delivery method so they can prepare for clinical trials. Burdick says they even plan to explore different therapeutic agents to increase the efficacy of the treatment.

"We will continue to understand how these materials work to produce the best therapy, including the introduction of other therapeutic agents into the hydrogel," he says. "We are now exploring the best ways to deliver the material down a catheter, which would allow for minimally invasive delivery, and these hydrogels could be used for the treatment of other tissues, as they have great properties for being injectable." 

Kristopher Sturgis is a contributor to Qmed.

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[Image courtesy of ACS]

Nestle Sees a Sweet Medtech Deal

The healthcare arm of food giant Nestle will pace its acquisition of Phagenesis by the milestones the British medtech company reaches.

Nancy Crotti

Phagenesis Phagenyx

Nestle Health Science plans to buy a British company that has developed an electrical treatment for a swallowing disorder.

Under terms of the agreement, Nestle will make an upfront payment to Phagenesis followed by milestone-based funding to the Manchester, England-based company while it completes the clinical evaluation for its Phagenyx device. The device is designed to treat dysphagia by restoring the neurological control of swallowing.

Patients who have suffered a stroke or are using artificial ventilation typically have trouble swallowing, with food and drink entering the lungs and causing infection. The Phagenyx device consists of a base station and a standard nasogastric feeding tube with built-in electrodes that provide electrical stimulation to the patient. The base station's software controls the intensity of the stimulation as set by an operator, according to company website.

Phagenesis expects a clinical study of the treatment that is underway at nine European sites will wrap up in January. The acquisition will be based upon successful completion of European and U.S. development programs, anticipated by 2019, according to a statement from the companies. Financial terms were not disclosed.

"Nestle Health Science is the leading global player in dysphagia, with capabilities and reach to enable Phagenesis to accelerate the development and deployment of Phagenyx to patients around the world," Phagenesis CEO Reinhard Kricki said in the statement. Nestle sells thickening powder for food and drink, and a nutritional pudding for people with dysphagia.

Harnessing Sensors and Data Management

Sensors and data management are changing the game when it comes to medtech product development. Learn how to use these tools to create your next winning innovation at MD&M Minneapolis on September 22. Qmed readers get 20% off with promo code Qmed16.

Dysphagia occurs in about 29% to 55% of the estimated 15 million patients who suffer stroke each year, according to a 2005 study in the journal Stroke. In addition to causing aspiration pneumonia, it can lead to malnutrition and dehydration. Standard treatment for neurologically induced dysphagia includes exercises and different swallowing techniques. Patients are also counseled to eat softer foods in smaller bites and to avoid dry foods. Such treatment addresses the symptoms, but Phagenyx was designed to treat the cause of dysphagia, according to the statement. The device has received the CE Mark in Europe, but has not been approved by FDA.

Nancy Crotti is a contributor to Qmed.

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[Image courtesy of Phagenisis]

Did Abbott Go Scorched Earth on Alere?

Alere's legal complaint claims that Abbott's CEO vowed to create a "living hell" to force Alere to end the merger agreement.

Nancy Crotti

Hell Alere AbbottAlere says Abbott Laboratories used some tough-guy tactics to try to get out of their $5.8 billion merger deal, according to a lawsuit filed by the diagnostic company.

Publicly, Abbott offered Alere $30 million to $50 million to end the agreement, which the companies signed in January. Alere's partially redacted lawsuit, unsealed this week in Delaware Chancery Court, paints a darker picture of what allegedly went on behind closed doors.

Abbott CEO Miles White threatened to make life a "living hell" for Alere if it didn't take Abbott's payoff, and warned it would drown Alere in a "sea of forensic-level informational demands" to find a reason to call it off, according to the suit.

Abbott made the public, multi-million-dollar withdrawal offer in April, a few weeks after Alere revealed that the U.S. Department of Justice had subpoenaed it about sales practices for 2013 through 2015 in Asia, Africa, and Latin America. Alere then said that it would delay its 2015 annual report, which it released last month.

Product Development Models Driving Innovation

Learn how to meet tough regulatory requirements and design devices hospitals will actually buy in this special conference track at MD&M Minneapolis on September 21. Qmed readers get 20% off with promo code Qmed16.

Alere maintains that Abbott wants out so it can more easily pursue its quest to buy St. Jude Medical for $25 billion. Abbott's debt load would triple if it bought both companies, the complaint says.

Alere also claims that Abbott "made the veiled threat" that it would essentially sabotage the deal "by failing to secure necessary regulatory approvals" unless Alere submitted to its demand to break it off.

Alere's stock has fallen from $40.77 one week ago to $38.93 this afternoon, far from the $56 per share Abbott had offered.

Abbott responded that it is "taking all steps necessary to secure antitrust clearance for the merger as promptly as reasonably practicable," claiming that Alere has caused the delays. The companies still have eight months to complete the deal, Abbott noted.

Alere's allegations are "nonsense and without merit," Abbott spokeswoman Darcy Ross said. "Their description of events is fiction and nothing but a publicity stunt."

Alere wouldn't elaborate on the lawsuit, but said the Waltham, MA company is looking forward to its day in court.

"The facts speak for themselves--as demonstrated by our complaint, Abbott has failed to fulfill its obligations under the terms of the merger agreement to promptly secure antitrust approvals and other regulatory requirements," Alere spokeswoman Jackie Lustig told the Boston Globe. "Alere will take all actions necessary to protect the interests of Alere shareholders, enforce Alere's rights under the merger agreement and compel Abbott to complete the transaction in accordance with its terms."

Alere, which makes diagnostics for a variety of infectious diseases, including HIV, dengue fever, tuberculosis, and malaria, has suffered other blows since the merger agreement was announced in January. Federal investigators subpoenaed the company's government-billing records dating back to 2010 for patient samples tested at Alere's Austin, TX, pain management laboratory.

Alere also previously disclosed that it had received subpoenas in December 2014 from the U.S. Attorney for the District of New Jersey asking for documents relating mostly to billing and marketing practices in toxicology testing, the Wall Street Journal has reported. More recently, Alere announced it is voluntarily withdrawing a device that tests the blood of patients who take blood thinners, following reports of inaccurate results.

Nancy Crotti is a contributor to Qmed.

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[Image courtesy of LoggaWiggler on Pixabay.]

Why Do You Love Your Job in Medtech?

Each year, we conduct MD+DI's Medtech Salary Survey as a service to our readers. We ask highly personal questions about your job and compensation in order to glean larger insights that can help you and your medtech peers go into your next performance review armed with information to ensure you're being paid fairly for the important work you do.  

Get the results of our 2017 Medtech Salary Survey free here.

But besides inquiring about your salary, bonus, and hours worked per week, we also ask why you do the work you do. I'm always amazed and inspired to see just how much most of you love your jobs and feel a sense of mission about working in the medtech industry. 

Sure, medtech is not an easy career path. In college, you probably put in a lot of hard study hours while many of your peers in less demanding majors were out partying. Once you land a job, the days can be long--more than one-third of the respondents to our survey put in 50 or more hours per week. Tough regulations may hamper your ability to innovate, and maybe you could make more money as a physician, a lawyer, or developing video games instead of life-saving devices. 

But for many of you, those downsides pale in comparison to the benefits you reap from a career in medtech.

For starters, there's job security. The aging population, rising incidence of chronic disease, and constant demand to reduce costs in healthcare ensure that a medtech professional's work is never done. 

"The world will always need medical care," as one of our anonymous survey respondents pointed out. 

The device business has also proved to be more recession-resistant than other industries and isn't as inclined to experience boom and bust cycles as other high-tech sectors. A number of respondents to our survey said medtech is an industry that seems to be keeping jobs--engineering positions, at least--onshore, too. 

"[Medtech is] one of the few growth areas available to engineers that still has a strong U.S. base," one respondent wrote.

Although you may be able to earn a higher salary by switching to a different industry like consumer tech, a career in medtech still offers employees the opportunity to make a good living. The median salary for medtech professionals was nearly $119,000 this year, according to our survey. That's more than double the median household income in the United States, according to the most recent statistics from the U.S. Census Bureau.

Even beyond practical matters like stability and pay, medtech has more to offer employees than many other industries. While a few respondents griped about regulations that stifle innovation, many said they relish the challenge the industry presents to them as employees. 

"The work truly matters," one respondent wrote. "Sometimes it can be frustrating in today's regulatory environment because it can seem difficult to be innovative and progress can be slow, but millions of people benefit from the work that we do."

The dynamic nature of the medtech industry also excites many of its employees. 

"After years of 'me-too' products that were safe derivatives of aging therapies, there are dozens of new, cutting-edge therapies and applications," marveled one respondent.

But, not surprisingly, one of the main reasons medtech employees say they love their jobs is because they get to truly make a difference in the world. No matter what your job at a medical device or diagnostics company--whether it be engineer or office manager, regulatory affairs or executive--you are undoubtedly helping to bring life-saving or life-improving technologies to those who need them most.

As one respondent asked rhetorically, "What better job can you have than helping to develop products that will help so many patients?"  

Jamie Hartford is MD+DI's editor-in-chief and serves as director of content for medical brands in UBM's Advanced Manufacturing Group. Reach her at [email protected] or on Twitter @MedTechJamie.

[image courtesy of STUART MILES/FREEDIGITALPHOTOS.NET]

MD&M Minneapolis Innovation Prize: Meet the Finalists

These are some of the most innovative exhibitors at the upcoming MD&M Minneapolis show.

Chris Newmarker

Innovation

A decontamination floor mat to help fight the huge problem of healthcare-acquired infections, a technology that helps combine some of the best aspects of 3-D printing and injection molding--those are but some of the technologies that caught the eyes of Qmed editors and readers as they selected the five MD&M Minneapolis Innovation Prize finalists.

The five finalists were chosen out of 13 MD&M Minneapolis exhibitors who submitted entries for the contest.

Check out the five finalists yourself on Wednesday, September 21, at 2 p.m., when Qmed senior editor Chris Newmarker leads an Innovation Tour out of Center Stage at MD&M Minneapolis. You'll be able to vote for the Innovation Prize winner at the end of the tour.

Circuit Solutions Vortex
(Image courtesy of Circuit Solutions)

(See these five exhibitors and more at MD&M Minneapolis. Qmed readers get 20% off with promo code Qmed16.)

Here are the five finalists:

1. Decontamination Floor Mat

Circuit Solutions (Minnetonka, MN)

Booth 1340

While there has been significant progress preventing some types of infections, about one in 25 U.S. hospital patients still suffer at least one healthcare-acquired infection on any given today, according to the Centers for Disease Control. About 75,000 patients with HAIs died during their hospitalization in 2011 alone. That's why an advanced decontamination floor mat got our attention. The Vortex Air WalkMat from Circuit Solutions leaves the old sticky paper mats in the dustbin and instead employs vacuum technology. The Vortex Air WalkMat cleans equipment wheels and the bottom of all types of footwear before and after people enter critical spaces in hospitals, clinics, and operating rooms, as well as cleanrooms and air showers in device manufacturing facilities. Registering the weight of arriving individuals or equipment, retractable balls on the surface of the mat activate the vacuum to remove particles, hair, and debris.

2. 3-D Printed Rapid-Prototyping Molds

Diversified Plastics (Minneapolis)

Booth 2138

3-D printing has been coming of age in the medical device industry. One area where it has already become commonplace is prototyping. Diversified Plastics, an injection molding specialist, has been seeking to take the prototyping to the next level. They use 3-D printing to create injection molds for producing prototypes--a method that combines the best aspects of both technologies. This 3-D injection molding (3-D IM) process enables the molding of prototype parts that are made of the actual resin selected for production. Diversified Plastics also boasts that 3-D IM is faster and more economical than than older methods of constructing soft-steel or aluminum molds.

Diversified Plastics Titan Trainer Mold 3-D IM
(Image courtesy of Diversified Plastics)

3. A Super Precise Knife Barrel Hinge

Liquidmetal Technologies (Rancho Santa Margarita, CA)

Booth 2432

Sometimes a much better crafted component has the potential to make a big difference. The Liquidmetal Hybrid Knife, which launched in fall 2015, includes a patent-pending barrel hinge that reduced part count for the knife to two, versus the multiple components typically required of barrel hinges. The transition between the open and closed position of the blade and its protector is at a smooth and precise 12.7 µm. Says Liquidmetal: "There are a broad range of medical device applications that could benefit from the barrel hinge, coupled with the design flexibility, precision, and material properties of Liquidmetal alloy. Many endoscopic devices today rely on opening and closing end-effectors whether it be for suturing, cutting, clamping, gripping, or sealing tissue."


Liquidmetal Knife
(Image courtesy of Liquidmetal Technologies)

4. A Mobile Health Breast Cancer Screening Solution

Pressure Profile Systems (Los Angeles)

Booth 2538

Mobile health offers a host of opportunities to better diagnose and treat diseases. So when a company touts a digital health device related to breast cancer, which kills tens of thousands of U.S. women annually, it is worth taking notice. The SureTouch system is a cloud-based medical device that includes a wireless handheld touch sensor, touch screen display, and a clinical information system to support telemedical consultations. The SureTouch's proprietary tactile sensor technology creates a high-resolution, handheld pressure sensor array that together with processing algorithms is able to identify masses in breast tissue. Says Pressure Profile Systems: "This digital, enhanced sense of 'touch,' allowsSureTouch to dramatically improve upon the limit of lesion size and depth detectable by conventional manual palpation techniques."


Zeus LCP Braiding
(Image courtesy of Zeus)

5. Non-Metallic Braid Reinforcement for Vascular Catheters

Zeus (Orangeburg, SC)

Booth 2105

Better visualization of soft tissue is needed more than ever as minimally invasive medical procedures increase in complexity. That means MRI compatibility. Enter Zeus with its LCP monofilament fiber, which Zeus is launching at MD&M Minneapolis. The LCP fiber boasts the performance of stainless steel wire braiding used in catheters for vascular procedures--without actually using metal. The LCP monofilament is braided over a catheter base liner during construction to provide mechanical strength and support, with the braiding then covered with a layer of Pebax or another nylon jacketing material reflowed under heat shrink. The reflow and bonding process causes the braiding to become fused between the nylon bonding material and underlying liner, achieving structural reinforcement. Zeus's proprietary processes are able to create a fiber with extremely low potential for fraying. 

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

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[Top "innovation" image courtesy of thinkpublic on Flickr]

What to Know About TMVR Technology

What to Know About TMVR Technology

Over the past few years, whispers about the promised of transcatheter mitral valve replacement (TMVR) technology have grown louder. Excitement about TMVR is reaching an all-time high, as several large medtech companies have invested in the area. In 2015 alone, Edwards Lifesciences purchased CardiAQ Valve Technologies, Medtronic bought Twelve Inc., and Abbott acquired Tendyne while also investing in Cephea Valve Technologies with an option to purchase. Stand-alone companies like Neovasc are also working on TMVR devices. 

Now, TMVR looks poised for the big time, as Edwards Lifesciences has announced it is kicking off a CE Mark trial for its TMVR system

At the MD&M Minneapolis conference on Wednesday, September 21, 2016, William Drasler of William J. Drasler Consulting and Robert Saeid Farivar, MD, PhD, chief of cardiothoracic surgery at Abbott Northwestern Hospital, will be part of a panel discussing the market opportunity for TMVR and the obstacles, both technical and clinical, the technology faces. 

 Learn more from these panelists during a discussion on "The Market Opportunity for Transcatheter Mitral Valve Replacement" at the MD&M Minneapolis Conference, on September 21.

We asked Drasler and Farivar some introductory questions about the state of TMVR technology today. Here's what they had to say:

In your opinion, what is the biggest obstacle in designing a transcather mitral valve? 

Drasler: Due to the anatomy of the mitral annulus both in its shape and tensile strength, the ability to secure a TMVR device without impingement of the native anterior leaflet upon the LVOT [left ventricular outflow tract] and without PVL [paravalvular leak] provide major challenges. Also, creation of stagnation pockets can result in generation of thromboemboli that are not tolerated. The TMVR device should also have a low profile to allow delivery across the atrial septum with alignment with the mitral annulus axis.

Farivar: Anchoring and profile in left ventricular outflow tract.

From your knowledge of the transcatheter mitral valves being developed now, what do you see as the most promising design, and why? 

Drasler: The best TMVR designs do not cause LVOT obstruction, are secured to the mitral annulus with stable healing that prevents PVL maintenance, and allows adequate blood flow across the native mitral leaflets to limit thrombus formation. The design should lend itself to delivery across the atrial septum.

Farivar: Tendyne (Abbott) for anchoring and Intrepid (Medtronic) for ease of placement.

As the first transcatheter mitral valve heads into CE Mark trials, what do you see as the major questions that need to be answered?

Drasler: The clinical trials should address similar issues that have been examined in TAVR trials including PVL, centro-valvular leaks, thromboemboli related strokes, and long-term valve function. In addition, the TMVR clinical studies should also examine LV functional changes that are potentially affected by an individual TMVR design, effects on LVOT outflow, effects on CFX [circumflex] artery blood flow, effects on left atrial electrical function, and all of the potential negative sequellae associated with delivery of the TMVR device via the apical approach.

Farivar: How do the patients do?

[Image courtesy of EDWARDS LIFESCIENCES]