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Articles from 2020 In June


Ancora’s IDE for CorCinch-HF Pivotal Study Greenlit by FDA

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FDA has approved Ancora Heart’s IDE application for the CorCinch-HF pivotal study.

The Santa Clara, CA-based company said the study is designed to evaluate the safety and efficacy of the AccuCinch Ventricular Restoration System in patients with heart failure and reduced ejection fraction (HFrEF). 

During the AccuCinch procedure, an implant is placed into the mid-left ventricular wall, the implant is then cinched. Once cinched, the implant is intended to reduce the size of the left ventricle, as well as support and strengthen the heart wall to help improve left ventricular function. The AccuCinch System is designed to provide extra stability and support to the left ventricular wall. This may lower stress on the heart and allow improved functional capacity and quality of life for patients.

Ancora Heart touted the study’s design, which will allow an initial analysis of safety and clinical efficacy for PMA submission after the first 250 patients have reached six months of follow-up, and then a second analysis after the entire cohort has reached twelve months of follow-up. The study will ultimately follow patients through five years post-treatment to track long-term results.

Jeff Closs, president and CEO of Ancora Heart said the company worked closely with FDA on the design and said the result was a testament to the agency’s “collaboration” and “flexibility.”

“For heart failure patients symptomatic relief is a big deal,” Closs told MD+DI. “They just want to feel better. They want to have a better quality of life, they want to be able to have more exercise capacity and if you do a lot of polling of patients living longer isn’t necessarily at the top of the list. At the top of the list is they just want to feel better when they wake up every day. What FDA has realized is that symptomatic improvement is very important.”

He added, “the first phase is to really demonstrate that we can improve day-to-day quality of life for these heart failure patients. We would then submit for a PMA approval for that indication of symptomatic improvement. "

Closs said there are two different endpoints Ancora Heart is looking at. The first allows an earlier PMA submission for symptomatic relief and a later phase of a larger sample size allows the firm to evaluate the mortality and hospital benefit.

COVID-19 IMPACT

Ancora Heart hasn’t gone untouched by COVID-19. The company said that procedures had to be delayed because of the pandemic. The firm said it expects to be back into clinicals in the August or September timeframe.

“We’ve clearly seen an impact [from COVID-19] on our ability to perform procedures,” said.  “A lot of elective and research projects have been put on hold. So, our enrollment in our early feasibility studies and our CE mark study have been impacted by our inability to travel and the hospitals’ prioritization on COVID-related care.”

He added, “What’s interesting is that we continue to enroll patients in the study,” he said. “In June, we had a number of new consented and enrolled patients in our study.”

 

New Titanium Foam Spinal Implant Comes Pre-Attached to Disposable Delivery Device

Image courtesy of Xenco Medical Titanium foam implant for spine surgery

Surgical implant maker Xenco Medical continues to flex is innovation muscles, most recently with the launch of an injection-molded titanium foam implant that comes pre-attached to a disposable delivery device.

“Optimized for energy absorption and bone in-growth, the interconnected network of pores that permeate each CancelleX porous titanium implant serve to achieve bone-like mechanical properties,” said Xenco Medical Founder and CEO Jason Haider (pictured above).

The San Diego, CA-based company said its CancelleX lumbar interbodies, inspired by cancellous bone, feature interconnected porosity throughout each implant and break new ground in the application of injection molding to the manufacturing of titanium spinal implants. Designed to promote bone apposition and facilitate vascularization, the titanium foam implant features high compressive strength, the company noted. Xenco also said that CancelleX is the first titanium foam implant of its kind to come pre-attached to a disposable, composite polymer delivery instrument (pictured below).

Image courtesy of Xenco MedicalTitanium foam implant for spine surgery comes pre-attached to disposable delivery device

 

Xenco touted the device's "remarkable strength to weight ratio, excellent biocompatibility, and the ability to produce capillary action throughout its structure," and said the titanium foam implant was developed by leveraging advanced manufacturing technology. The company also said the delivery instruments attached to each titanium foam implant are optimally calibrated and sterile-packaged for patient-specific use.

Not Your Father's Spinal Implant Company

Xenco Medical distinguished itself a few years ago by packaging surgical instruments and spinal implants together according to size and procedure in sterile, single-use systems. Later Xenco introduced a smartphone app for surgeons to use to order kits for upcoming procedures. But the company really made a name for itself last year by launching an interactive vending machine for dispensing those sterile-packaged systems (pictured below).

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“It’s been important to not only develop new implant systems but to construct a new framework for delivery,” Haider previously told MD+DI. “I wanted to develop an automated dispensing solution around our sterile systems from the beginning but waited until we had several years’ worth of feedback from both surgeons and hospital administrators from around the country. My concept of a surgical vending machine itself was born by observing novel applications of automation over time, with automated vending kiosks in airports serving as an early example. Through an iterative process, Xenco Medical’s interactive vending machine reflects a multitude of inputs from across the country, which ranged from a need for secure access and traceability to on-demand training for hospital staff.”

In 2018 Haider told MD+DI's sister publication, Packaging Digest, that he started the company to address what he called an “antiquated medical device supply chain,” and he estimated that sterilizing and transporting such reusables after each operation requires a minimum of 3.5 hours to complete.

“With the sterilization costs alone approaching $1000 for each surgery, the lost surgical time due to the unavailability of instrument and implant sets is particularly costly to small facilities with limited resources and patient volumes such as outpatient surgery centers,” he said.

With Xenco’s solution, Haider said, disposing of the single-use surgical instruments could range “from 9 cents to 71 cents, and the savings from sterilization alone averages from $850 to $950 dollars per case."

It Isn’t Over: Moving Forward Safely in a COVID-19 World

Image Courtesy of Sciessent Mask_FullView_web.JPG

COVID-19 has hit the U.S. healthcare industry like a category five hurricane—an unexpected, widespread disaster that has taken lives and drained critical resources. One area hit particularly hard is the supply chain, with healthcare institutions scrambling to secure the supplies their providers need to protect themselves and their patients from this rapidly spreading illness.

Personal protective equipment (PPE), including masks and gowns, is a frontline defense against COVID-19 for healthcare workers, who can’t adhere to social distancing guidelines when providing hands-on patient care. While traditional PPE suppliers have significantly boosted production of their products and the U.S. government has called on companies from outside of the industry to redirect staff and factory lines to the manufacture of PPE, the demand continues to outpace product delivery. 

As state governments begin to relax restrictions intended to slow the spread of COVID-19 and companies start opening their doors, it’s easy to feel a false sense of security that as a nation we have outsmarted and subdued the virus. But in reality, the fight is just beginning: COVID-19 is a long-term reality, and we are likely to see a resurgence as we emerge from our homes and attempt to restart our lives after a national pause. Although prevention and treatment strategies for COVID-19 will eventually become available, they may not eradicate the risk of infection.

As a result, more people will get sick, and healthcare workers will continue to be the first line of defense. The strain on PPE resources will increase in the short term as hospitals and other healthcare facilities resume elective surgical procedures, annual primary care appointments, and other types of care that have been delayed because of the pandemic. Active infection with capacity for transmission has been observed in asymptomatic individuals, making PPE at these visits particularly critical. Hospitals, outpatient clinics, and other care settings (e.g., long-term care facilities, prisons, homeless shelters), government agencies (e.g., CDC, HHS, FDA), and PPE manufacturers all have a responsibility to provide healthcare practitioners with the products and information they need to protect themselves from COVID-19 exposure during the course of delivering patient care.  

These stakeholders must collaborate not only to boost the production of current PPE, but also to develop new PPE solutions that provide protection in a wider range of healthcare delivery settings. For example, areas of current supply shortages and exposure risk and opportunities for improvement include:

  • Reusable versus disposable PPE: One of the greatest challenges facing healthcare—and one that will continue to grow—is simply not having enough PPE to protect healthcare workers. Today most of the PPE supply, particularly gowns and gloves, are designed for single-use only. Developing PPE manufactured from materials that can be decontaminated and reused should be a priority.
  • Active defense PPE: Most PPE today is passive defense, i.e., designed to prevent viral transmission. For example, an N95 respirator filtration mask worn correctly can capture 95 percent of particles 0.3 microns or larger from filtered air. That remaining 5 percent of airborne particles still presents a risk. A mask that not only blocks but also inactivates pathogens before reaching the wearer would combine both active and passive defense mechanisms for greater protection. 
  • Donning and doffing PPE: Putting on PPE before caring for a COVID-19 patient (donning), then removing it after care has been delivered (doffing), is complex and time consuming, and it is a potential source of exposure to the wearer while removing contaminated PPE. Healthcare workers responsible for taking care of a growing population of COVID-19 patients don’t have time to spare. The development of safer and more efficient PPE use practices will reduce risk. 

While states are easing restrictions and re-opening businesses and gathering spaces and people are beginning to resume more normal activities, COVID-19 remains a serious threat. 

Nobody recognizes this more than the healthcare providers who continue to care for infected patients as they attempt to shield themselves and their families from contracting the virus. They are still experiencing the risks firsthand and the strain on the healthcare supply chain’s resources as they ration PPE so there is enough for everyone on the frontlines of care. 

Although government agencies, healthcare organizations, and manufacturers are working diligently to replenish the supply chain with PPE and ease the burden, a recurrent national surge of infections could overwhelm such efforts. In addition, we encourage these entities to develop novel PPE strategies that minimize the risk to healthcare workers and the limitations of current approaches.

Qure.ai Secures FDA Clearance for Head CT Scan Technology

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Qure.ai said it has received FDA clearance for its first head CT scan product.

The San Mateo, CA-based company’s technology is called qER and can be used to triage radiology scans with intracranial bleeds, mass effect, midline shift, and cranial fractures.

Two of these capabilities – cranial fractures and midline shift – are exclusive to Qure.ai's product. This means that the newly cleared qER suite will be able to triage nearly all critical abnormalities visible on routine head CT scans.

"Patient outcomes depend directly on the onset-to-treatment time, especially for brain injuries,” Pooja Rao, Co-founder and R&D head, Qure.ai., said in a release. “Every day doctors are required to weigh the benefits of a potentially life-saving surgery vs. the risks of an intracranial bleed or other complication. The sooner they have in-depth information that helps them make that decision, the better for the patient. This is where qER plays a key role. We wanted to offer a comprehensive solution to the clinicians, rather than a partial one that triages on the basis of limited or even single findings.”

The company said the qER suite plugs directly into the radiology workflow and prioritizes critical cases on the worklist. This triage drastically reduces the time taken to open critical scans, so those with time-sensitive abnormalities get to be read and reported faster, leading to better patient outcomes.

Qure.ai made headlines earlier this year when it struck an accord with Neve-Ilan, Israel-based Nanox. The agreement called for Qure.ai’s diagnostic solution to be integrated into the Nanox.CLOUD platform.

 

Multi-Site Study Tracks Immune Response of COVID-19 Patients

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Fluidigm’s mass cytometry technology and its Maxpar Direct Immune Profiling Assay are being used in a prospective observational cohort surveillance study of up to 2,000 adult participants hospitalized with COVID-19.

The study, which is titled Immunophenotyping Assessment in a COVID-19 Cohort (IMPACC), is being conducted by the National Institutes of Health’s National Institute of Allergy and Infectious Diseases, in collaboration with the Human Immunology Project Consortium and the Asthma and Allergic Diseases Clinical Research Consortium.

“The goal of this study is to look at a much larger cohort of people that were infected and we also wanted to look at the differences geographically in a lot of different centers,” Andrew Quong, Fluidigm's Chief Science Officer, told MD+DI.

He added, “In addition to looking at one or two time points they are looking at how the immune system is impacted long term. They’re collecting data not just when the person is admitted with bad clinical symptoms. They’re also trying to collect samples after the patient has been released. So, the study includes timepoints up to a year after a release because the disease seems to be much more impactful than something like influenza. It’s important to understand the effect it has on the general immune system.”

COVID-19 patients age 18 and older are enrolled in the study within 36 hours after admission to a hospital. Samples are collected from nasal swabs, blood, and tracheal fluid at 10-time points from hospital admission to up to one year after discharge. When possible, researchers will also examine lower airway secretions collected from patients requiring a ventilator for breathing support.

“There are many unanswered questions about the diversity of the COVID-19 patient journey, why some experience only mild symptoms while others face life-threatening complications,” said Chris Linthwaite, President and CEO of Fluidigm said in a release. “A deep and meaningful understanding of the immune system during the course of infection and in response to therapies is of critical importance in fighting this pandemic.

Linthwaite added, “Fluidigm is battling this pandemic on multiple fronts, having filed for Emergency Use Authorization from FDA for an extraction-free saliva-based test to detect the COVID-19 virus. We are gratified for the inclusion of our technology in the IMPACC study, and we look forward to new discoveries that can potentially have an impact on patient lives.”

 

Beckman Coulter Looks to Stand Out in Antibody Test Crowd

Andrei-stock.adobe.com Beckman Coulter

While the number of antibody or serology tests for SARS-COV2 is growing each week, one in vitro diagnostics company has a plan to stand out from the pack.

On Monday, Beckman Coulter, a Danaher Corp. company, announced it too had emergency use authorization for the Access SARS-CoV-2 IgG test. The Brea, CA-based company said it has shipped tests to more than 400 hospitals, clinics, and diagnostics laboratories in the U.S. and said it is able to deliver more than 30 million tests a month.

During an interview with MD+DI, Julie Sawyer Montgomery spoke about the test and what the EUA means for the company going forward.

“We had many customers that who had validated our tests but were holding the use of the tests until we had the EUA, because they wanted to see that stamp of approval from FDA,” Sawyer Montgomery told MD+DI. “But now that we have it, we expect to see a significant increase in the use of our test.

She said the firm’s design choice for the test helps it stand out.

“The first design choice we made is that the test is specific to igG antibodies,” Sawyer Montgomery, told MD+DI.  “Of the automated-high volume tests out there, there are two kinds. A total antibody test measures all antibodies together in a single metric, including the early but more fleeting immune response. The IgG represents that longer-lasting immune response. It’s our belief that [IgG] is clinically more important information.”

She added, “The other key design choice we made was the selection of our antigen. We chose the receptor-binding domain of the spiked protein because we wanted to have a test that was most likely to detect neutralizing antibodies. Of the big four IVD manufacturers, we are the only one of those that has an IgG-specific assay that’s targeting the receptor-binding domain of the spike. We’re very proud of the quality of our tests.”

Antibody Testing is a Hot Topic

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Antibody testing has been a controversial topic lately. Chembio came under fire and even had the EUA for its antibody test revoked after it was revealed there were performance concerns with the accuracy of the test.

In May, FDA took action and revised its March 16 policy, which has served as a regulatory roadmap for COVID-19 antibody tests. The revision came about two weeks after FDA issued a warning to healthcare providers about the limitations of such tests.

One key factor for Beckman Coulter is the work and research physicians at Henry Ford Health system conducted to evaluate the test.  Physicians at Henry Ford found when running the Beckman Coulter SARS-CoV-2 assay on 204 PCR-confirmed COVID-19 patient samples, a test sensitivity of 100% at 14 days post-PCR and testing of 80 patient samples from the pre-COVID era yielded a specificity of 100%."

“There has been confusion caused by the initially-launched tests in their poor-accuracy,” Sawyer Montgomery said. “So, there is still a lot of news coverage that is concerned about the positive-predictive value. Now that Beckman Coulter and others have launched a much higher quality test, we have better options. That’s going to – as a result, drive greater levels of testing.”

Looking to the Future

COVID-19 Rates continue to climb in the U.S. There are more than 2.6 million cases and 128,452 deaths, according to worldometers.info.  

During Danaher’s most recent earnings call Tom Joyce, the company’s president and CEO spoke about the growing-role for serology/antibody tests.

“I think, the way we see serology evolving over time is it's going to be primarily driven obviously with a blood draw,” Joyce said according to a transcript of the earnings call from Seeking Alpha. “And you're going to see the serology test, the IgG test integrated into more routine testing. And therefore, the cost per test is going to be quite reasonable and it's going to be in line with other immunoassay tests. 

 

 

Volunteers Team Up to Develop a New Ventilator During the COVID-19 Pandemic

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Robotics entrepreneur Tyler Mantel paused his work on his own startups to create a nonprofit organization consisting of individuals from a variety of companies. Mantel’s project is developing a new ventilator that solves complicated engineering problems and thrives within the unique ecosystem of the supply chain during this new pandemic world. MD+DI spoke with Mantel, president of The Ventilator Project, about the organization, the ventilator itself, and how the medical device industry can get involved.

On March 20 of this year, Mantel started The Ventilator Project with the goal of providing ventilators that would help during the COVID-19 pandemic. “We knew that if the ventilator shortage remained unresolved, many could die,” he said on the project's Web site.           

Days later, there were 15 engineers working on the project. Within a month, the team had a prototype ready. Now The Ventilator Project has more than 250 people working in various capacities to get their device, known as AIRA, to market. 

“The people on our project come from companies as disparate as Amazon Robotics to GE Healthcare. We have people from Apple, Google, Clear Motion, and Procter & Gamble—all the way up to the executive levels of these companies,” said Mantel. “The number and the quality of these people who have come out of the woodwork to help solve this global need, that has been the reason we've been successful so far.”

The idea for AIRA was conceived after posing a series of questions to doctors, purchasing managers, and hospital administration to get to the root of what type of ventilator would be most safe and efficient, said Mantel. “And what we've learned is that it has to be easy to use, easy to store, and safe for the patient,” he explained.

AIRA aims to solve many of the challenges that typical ventilators face and to be less expensive as well. “We're looking at a market of ICU ventilators that cost $25,000 to $50,000 and aren’t inherently storable or scalable for the global market,” he said, noting that one of the unique properties of AIRA is that it is easily stored and transported.

This is important, Mantel said, because a typical ventilator spends almost its entire life cycle in storage. “When it comes out of storage, it is one of the most important pieces of equipment to one person's life,” Mantel explained. “So it has to be able to sit in storage for most of his life and come off the bench ready.”

Image courtesy of The Ventilator ProjectThe Ventilator Project

Within the next couple of weeks, The Ventilator Project will finalize its documents to file an Emergency Use Authorization (EUA) with FDA. “Right after we get the EUA, we'll turn our sights on [getting a] 510k and simultaneously go after certifications around the world,” said Mantel. 

The Ventilator Project has more than 50 manufacturing partners set up at every level of its supply chain, Mantel said, and “when we get this safely into market we can absolutely hit the ground sprinting.”

Right now, Mantel said The Ventilator Project is laser focused on how it can save lives with the ventilator but has visions for other products on the horizon. “The future of this company will consist of filling the gaps in the medical market. We will always put the customers at the top of our decisions and you can bet some really innovative products will come on the tail end of that,” Mantel said. 

“There are people out there who want to step out and solve these human problems. It doesn't go away with ventilators,” Mantel said. “We can use this platform and position in the world to make sure that we can find other areas similar and ensure that we don't get into this position again,” he concluded.

Mantel encouraged anyone who is willing to give time, money, or expertise to get involved with The Ventilator Project. He will be speaking in the upcoming BIOMEDigital session, Heroes of Rapid Product Development & Manufacturing — The Ventilator Project, on Thursday, November 5 at 9:00am - 10:00am ET.

 

Editor's note: This article was updated October 28, 2020, with the BIOMEDigital session details.

Tandem and Abbott’s Big Play in Diabetes Management

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Two of the biggest players in diabetes are teaming up to significantly impact management of the chronic illness.

San Diego, CA-based Tandem Diabetes is integrating its insulin delivery systems with Abbott Laboratories’s Freestyle Libre. The pair are finalizing an agreement that was made in October of last year.  

"We're excited to integrate our insulin delivery systems with Abbott's glucose-sensing technology, and we look forward to expanding options for our customers so that they can combine devices that best suit their personal needs," said John Sheridan, president and CEO of Tandem Diabetes Care. "We are proud to have an insulin pump capable of remote software updates that can make access to future integrations possible for in-warranty t:slim X2 users at the time of release without requiring a new pump."

 Through this collaboration, Abbott and Tandem will work to digitally connect their technologies for future automated insulin delivery systems.

The companies will focus initial commercial activities in the U.S. and Canada with additional geographies considered in the future.

Tandem accomplished a major milestone for diabetes technology when it won a nod from FDA for the t:slim X2 insulin pump in February of last year. The approval opened up a new device category – Alternate Controller Enabled Infusion Pumps.

Abbott shook up the diabetes market when it won a nod from FDA for the Freestyle Libre. The approval is largely considered a major win for those with diabetes because it eliminated routine finger sticks, which have been the standard of glucose testing for more than 40 years.

However, Tandem and Abbott have recently made significant moves in the diabetes space. Last week, Tandem picked up Sugarmate, a developer of a mobile app for people with diabetes who use insulin, for an undisclosed sum.

Abbott finally received a nod from FDA for the long-awaited Freestyle Libre 2 iCGM. The second generation of the device expands on the first because it can be used in children over the age of four. It also differs because it has Bluetooth capabilities and optional alarms.

In October of 2019, MD+DI reported how the Freestyle Libre 2 was one of Abbott’s most anticipated devices.

 

Intact Vascular Shows Success with BTK Vascular Implant

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Intact Vascular is reporting positive results from a clinical trial of its below-the-knee vascular implant for post-angioplasty dissection repair.

The Wayne, PA-based company announced the results of the Tack Optimized Balloon Angioplasty (TOBA) II BTK clinical trial during the 2020 Vascular Interventional Advances (VIVA) Late-Breaking Clinical Trial livestream. The study is evaluating the Tack Endovascular System.

The device demonstrated an 81.3% K-M Tacked Segment Patency and a 78.6% K-M Target Lesion Patency, with an 83.1% K-M Freedom from Clinically-Driven Reintervention at one-year. No fractures, embolization or migration of the Tack device were observed, confirming the durability of the minimal metal implants.

The firm said additionally in the critical limb ischemia (CLI) cohort, a population associated with high rates of amputation and mortality, Tack implants demonstrated remarkable 96.1% K-M Target Limb Salvage and 89.0% Amputation-Free Survival.

“This unprecedented trial is the first to investigate the safety and efficacy of a permanent vascular implant for repairing dissections in arteries below-the-knee. It enrolled a complex, predominantly CLI patient population that included 100% dissected vessels,” Peter Schneider, M.D., Co-Founder and Chief Medical Officer of Intact Vascular, said in a release. “These excellent one-year data highlight the clinical importance of below-the-knee dissection repair and validate the sustained durability of Tack implants.”

Intact Vascular is sponsoring three clinical trials to evaluate its Tack Endovascular System: TOBA II, TOBA II BTK and TOBA III. MD+DI spoke with the company about plans for clinical trials back in 2018.

TOBA II is investigating the combination of the Tack implant with plain angioplasty balloons or the BD Interventional Lutonix drug-coated balloon (DCB) in arteries above-the-knee and has completed its primary endpoint analysis.

TOBA II BTK has completed its primary endpoint analysis and is investigating the combination of the Tack implant with plain balloon angioplasty in the arteries BTK.

TOBA III has completed its primary endpoint analysis and is investigating the combination of the Tack implant with the Medtronic IN.PACT Admiral (DCB), with the inclusion in the study of a long lesion subset. 

Innovation is Being Redefined During COVID-19

Just what does innovation mean during COVID-19.  We're offered up a pretty big clue when we look at the recent actions of Chicago, IL-based Augmedics, a company that has developed the xvision Spine system (XVS), an augmented reality surgical image guidance technology.

MD+DI Managing Editor Omar Ford explains why the company's recent financing round is the perfect example of how companies should think of innovation going forward.