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Articles from 2020 In August


CardioMech Obtains Funding to Support Future In-Human Feasibility Trial for New Mitral Valve Repair Tech

Image courtesy of CardioMech Nehm Headshot web.jpg
“What we're seeing is that physicians prefer technologies that give them the ability to treat the patient and give them options,” according to Rick Nehm, CEO of CardioMech, which is developing new mitral valve repair technology.

Mitral regurgitation, the backward flow of blood from the left ventricle into the left atrium, is the third most common cardiovascular disease in the United States, Rick Nehm, CEO of CardioMech, said in an interview with MD+DI. It occurs when the mitral valve leaflets do not close properly or when the heart is enlarged. Nehm explained that there are more than four million people a year with this condition, which can cause stroke, pulmonary hypertension, and heart failure, and eventual death, if not treated.

“The gold standard for treatment is cardiac surgery, and cardiac surgery is excellent for patients that have mitral regurgitation,” Nehm said. “They do very well and select surgeons perform the procedure with great outcomes. So, it is the gold standard, but it does involve opening the sternum, stopping the heart, and going on heart-lung bypass.”

Because of this, he said, the open-heart procedure involves some risk and certainly a long recovery. Additionally, physicians use an algorithm to determine if patients are low, intermediate, or high risk for undergoing the surgery. “If they are high risk, the patient cannot have surgery,” Nehm said. “So the original impetus [in developing this technology] was to be able to treat those patients,” he continued. “What we found, though, is that there is at least a potential utility for this device even in patients where cardiac surgery is warranted.” He emphasized that the device is still in the early R&D development phase and is not approved or cleared by FDA or any other regulatory body.

The technology is designed to offer a fully percutaneous transfemoral, transseptal placement of artificial chord(s) with anchors on each end, one for the mitral valve leaflet, the other for the left ventrical wall. The chord(s) can be adjusted on the beating heart, under echocardiographic guidance, until the regurgitation is reduced or eliminated.

“Our anchors are fully repositionable and retrievable,” Nehm said, “Which means if the physician places the anchors in a certain area and the physician does not like what he or she sees, they can, in an atraumatic way, recover the anchor and redeploy it elsewhere.”

The device could be used as a primary therapy, leaving open the option of further transcatheter or surgical options, Nehm said. “What we're seeing is that physicians prefer technologies that give them the ability to treat the patient and give them options,” he explained. “So the more optionality built into the technology, the more options physicians have to better treat their patients.”

CardioMech recently closed on its Series A financing round of $18.5 M that will fund its journey to conduct its first in-human feasibility trial. Nehm said the company will soon submit an IDE to FDA that may give CardioMech permission to conduct a study in the United States. The 2021 study will likely take place in five centers with up to 15 patients. The next step would be a larger randomized controlled trial.

“Something special is going on here,” Nehm concluded. “I believe we are building a technology that could dramatically improve the standard of care for patients with mitral regurgitation.”

HHS Ends Ventilator Contract with Philips

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The U.S. Department of Health and Human Services is canceling the remainder of a contract with Royal Philips for ventilators. The company issued a news release about the cancelation earlier today.

Philips said the agreement was signed in April and called for the Amsterdam, Netherlands-based company to deliver 43,000 EV300 ventilators to HHS through December 2020.

Philips said it will complete the deliveries for this month, resulting in a total of 12,300 bundled ventilator configurations supplied to the Strategic National Stockpile by the end of August 2020, in line with the contract. As directed by HHS, Philips said it will not supply the remaining 30,700 Philips EV300 ventilators to the Strategic National Stockpile.

“To date, we have delivered on our commitments to HHS,” Frans van Houten, CEO of Royal Philips said in a release. “I am proud that with great urgency and under intense pressure, we achieved a fourfold ventilator production expansion with substantial investments: we hired hundreds of new colleagues for our factories in the U.S. and called upon our supply chain partners to massively step up, all in response to the COVID-19 pandemic. While we are disappointed in light of these vast efforts, we will adjust our plans and work with HHS to effectuate the partial termination of this contract.”

Philips said as the epicenter of the pandemic started to shift to the West in February 2020, Philips reached out to various governments around the world to discuss how to collaboratively combat COVID-19. From March 2020 onwards, Philips achieved a massive fourfold increase in ventilator production in just five months, adding production lines in the U.S. as well as creating hundreds of new jobs. Employees in Philips’ factories in Western Pennsylvania and California have been working around the clock to produce these ventilators. 

The contract’s cancelation comes hot on the heels of a scathing report from the Democratic members of the House Oversite Committee, noting that that Trump administration had failed to properly manage and negotiate contracts for ventilators, according to a report from CBS News.  

The House Oversite Committee said the Trump administration had agreed to pay $15,000 each for Trilogy EV300 ventilators, after Phillips failed to provide the 10,000 Trilogy Evo Universal ventilators that were ordered in 2014 for $3,280 each, according to the report from CBS News.

Near the start of the pandemic, ventilators were in extremely high demand. It was thought there was going to be a shortage of the machines. Even companies in the automotive industry jumped in and started developing the devices.

To mitigate shortage concerns Medtronic allowed other companies to use the design specs of an older model of its Puritan Bennett ventilators.

Even companies like Fitbit jumped into the mix to develop ventilators – winning an EUA from FDA.

2020 US Election: What Republicans Said About Healthcare

The 2020 Republican National Convention was held Aug. 24 – Aug. 27. These were the statements about healthcare that grabbed our editors' attention throughout the convention. 

NeuroPace Raises $67M to Advance Neuromodulation Therapy

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NeuroPace has raised $67 million to support the commercial expansion of its technology for refractory focal epilepsy. The Mountain View, CA-based company said the financing includes $33 million of new equity capital and $34 million from convertible debt provided by current investors from a prior funding round.

The round was led by Accelmed Partners with participation from an unnamed strategic investor, Revelation Partners, Soleus Capital, and returning investors KCK Group and OrbiMed Advisors.

NeuroPace said its RNS System is the first and only FDA approved brain-responsive neurostimulator designed to prevent seizures before they start. The company first landed FDA approval about seven years ago.

The RNS System is a closed-loop, brain-responsive neurostimulation system that was designed to prevent epileptic seizures by stopping them at the source. The device uses a brain-computer interface that was designed to treat seizures by continuously monitoring brain waves to recognize each patient’s unique seizure onset fingerprint.

“This round of financing will enable us to execute our commercial strategy and maximize therapy adoption at comprehensive epilepsy centers,” said Mike Favet, CEO of NeuroPace. “It will also fund a clinical trial to expand our indication to patients under 18 years old, a population whose quality of life is especially impacted by epilepsy. We now have the highest seizure reduction rates reported by any epilepsy neuromodulation device, a robust product innovation pipeline, and market expansion opportunities. With this additional funding, we can bring RNS System’s life-changing technology to significantly more people who are living with refractory epilepsy.”

Recently published data show an unprecedented 82% median seizure reduction at three or more years, as well as enduring improvements in quality of life and cognition. In addition to proven clinical benefits, NeuroPace said the RNS System is the only device that continuously monitors and records EEG data, providing data-driven insights that enable physicians to optimize their patients’ epilepsy care.

Earlier this year, the device landed a PMA for MRI labeling. The technology is also being used in a clinical investigation that will examine whether neuromodulation could be effective as a means of managing loss-of-control eating for patients.

With this study, NeuroPace is venturing out into new territory.

Medtech in a Minute: Convalescent Plasma Controversy, and More

Image by OpenClipart-Vectors on Pixabay Medtech in a Minute

FDA Head Apologizes for Overstating Convalescent Plasma Benefits

FDA Commissioner Stephen Hahn apologized last week for overstating the benefits of convalescent plasma therapy for COVID-19 patients. The bone of contention stems from Hahn saying that preliminary findings from a Mayo Clinic studyshowed there was ‘absolute’ instead of ‘relative’ risk reduction of COVID-19 in patients who were treated with convalescent plasma. The theory behind convalescent plasma is that people who have been afflicted with COVID-19 that have recovered will have antibodies in the blood that helped fight off the infection. The thought is that if people who are sick with the virus are given this plasma they could recover. FDA gave emergency use authorization to the therapy last weekend. The EUA was based on clinical results from the Mayo Clinic study. In an interview with CBS This Morning, Hahn warded off criticisms that FDA was pressured to grant the therapy EUA. “I could have done a better job, and should have done a better job, at that press conference explaining what the data show regarding convalescent plasma," he said. "I can assure the American people that this decision was made based upon sound science and data.”

Foundation Medicine Scores FDA Nod in Liquid Biopsy

Foundation Medicine added another chapter to the liquid biopsy story after it won approval for a Pan-Tumor test with multiple companion diagnostic indications. The Cambridge, MA-based company made the Foundation Liquid CDx available on Friday and said the diagnostic is covered across all solid tumors for eligible Medicare and Medicare Advantage beneficiaries. FDA approval was based on analytical and clinical validation studies that included more than 7,500 samples and 30,000 unique variants across over 30 cancer types. Evaluation of the platform using multiple validation methods across a broad range of tumor types demonstrated high sensitivity and specificity, even at the low allele frequencies often observed in clinical blood samples.

Abbott Scores Another COVID-19 EUA

FDA issued an emergency use authorization (EUA) for Abbott’s BinaxNOW COVID-19 Ag Card for rapid detection of COVID-19 infection. Described as being about the size of a credit card, the test is priced at $5 and can generate results in 15 minutes, according to Abbott. The BinaxNOW COVID-19 Ag Card uses Abbott’s lateral flow technology, and testing professionals do not need special equipment for sample processing. The EUA authorizes the test to be used by healthcare professionals in point-of-care settings. The test can also be used by professionals in near-patient settings.

Foundation Medicine Secures FDA Nod for Pan Tumor Test

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Foundation Medicine added another chapter to the liquid biopsy story after it won approval for a Pan-Tumor test with multiple companion diagnostic indications.

The Cambridge, MA-based company made the Foundation Liquid CDx available on Friday and said the diagnostic is covered across all solid tumors for eligible Medicare and Medicare Advantage beneficiaries.

FDA’s approval of FoundationOne Liquid CDx was based on analytical and clinical validation studies that included more than 7,500 samples and 30,000 unique variants across over 30 cancer types. Evaluation of the platform using multiple validation methods across a broad range of tumor types demonstrated high sensitivity 1 and specificity, 2 even at the low allele frequencies often observed in clinical blood samples.

The test analyzes more than 300 cancer-related genes for alterations.

“We believe that cancer patients and their physicians deserve the highest quality genomic testing to make informed decisions about personalized treatment,” said Brian Alexander, M.D., M.P.H., Chief Medical Officer at Foundation Medicine. “Created from our scientific expertise and pioneering spirit, FoundationOne Liquid CDx underscores our commitment to advance patient care across all cancer types by bringing forward multiple FDA-approved comprehensive genomic profiling options that are increasingly essential for high-quality cancer care. We are seeking additional companion diagnostic claims for FoundationOne Liquid CDx, which, if approved, would further enhance the utility of the test in clinical practice. Additionally, this test is an important tool for the acceleration of drug development and for understanding mechanisms of resistance.”

This is the second significant approval in the field of biopsy in August. Earlier this month, Guardant Health won a nod from FDA for a liquid biopsy solution for comprehensive tumor mutation profiling across all solid cancers.

The Guardant360 CDx’s approval was based on clinical and analytical validation data from more than 5,000 samples.

 

Selecting a Debinding Fluid for 3D Printed Components

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Metal 3D printing, a subset of additive manufacturing, is gaining traction with medical device manufacturers today. They use metal 3D Printing in a variety of ways. The most common is to make simple manufacturing support items like jigs, fixtures, and other machine tooling. But it is also used for small-volume runs of very complex parts and intricate surgical instruments. Or to make highly-customized medical devices such as bone grafts, orthotics, and prosthetic limbs.  In addition, device makers turn to metal 3D printing when security is a concern. Rapid in-house 3D prototyping, means device designs are never publicly shared, helping to ensure the confidentiality of their innovative new designs.  

There are many types of metal 3D printing methods used today. However, many designers choose binder jetting because it is less expensive, faster, and easier-to-use than other methods. Binder jetting builds a part out of fine metal powders and binders. It creates the part on a powder bed by depositing alternating layers of metal powder and binders.  The part builds, in thin horizontally progressive layers, until it reaches its final shape.

A variety of metal powders including medical grade stainless steel, low alloy steels, carbon steels, Ni-alloys, tool steels, and tungsten alloys are used to build small, precise, and detailed medical devices and surgical instruments. Common types of binders are paraffin wax, carnauba wax, and specialty polyethylene waxes.

The binders help form the metal powder into a specific shape. However, the binders are temporary.  Only a very small amount of binders must stay inside the part to keep it from deforming and cracking during sintering. The rest of the binders are carefully removed to allow for faster sintering. Removal of the binders typically reduces the sintering time from days to mere hours. Successful part debinding is a balance of selectively removing the right amount of binders as quickly as possible without damaging the fragile part.

The part is thermally sintered at near melting temperature. This burns off any remaining binders and bonds the metal powder to its solid mass state, typically 96-99.8% density. After that, the part is post-processed using standard finishing techniques like sanding, painting, or coating.

In some shops, part debinding typically happens inside a vapor degreaser using a specialty debinding fluid. Dunking a part into the fluid or holding it inside the fluid vapors, dissolves the binders and transports them away from the part.

Part debinding is a straightforward process. However, it is important to get the details right for the best possible end product. The debinding fluid must discriminately remove some of the binders, but not all, to ensure the part maintains its structural integrity. To achieve this, the physical properties of the debinding fluid are important. Here is what to look for:

Debinding fluid performance

Low viscosity: Less viscous fluids flow around and into the metal part more easily for more complete debinding.  

Low surface tension: Low surface tension allows the fluid to work its way into the part, especially inside tight, internal geometries to remove the binders.

Correct strength: The debinding fluid should be aggressive enough to selectively remove the right amount of binders yet still maintain the part’s integrity. 

Good materials compatibility: The debinding fluid should be safe to use both with the metal powders and the binders to safeguard the formed part.

Fast evaporating: A fast evaporating debinding fluid ensures no gasified binders are left behind in the part. Remaining fluid inside the part could result in cracking, deformation or part expansion during sintering. Plus, a fast-evaporating debinding fluid means the metal part dries quicker, resulting in faster production times.

Low boiling: Low boiling debinding fluids still melt the wax binders but do not damage the non-soluble fragile part. Plus, it allows the vapor degreaser to run more efficiently. It also shortens the vapor degreaser start up time, lowering overall energy use and costs.

Maintenance-free: Modern debinding fluids do not require stabilizers, scavengers, or weekly acid acceptance testing to sustain their integrity, reducing maintenance time and costs.

 

Debinding fluid safety and compliance

Low toxicity:  Modern debinding fluids do not use n-propyl bromide, methyl pyrrolidone, polyethylene glycol, heptane, or trichloroethene which all carry serious health and or environmental concerns.

Nonflammable: Nonflammable debinding fluids are safer for workers and do not require specialty fire or explosion-proof equipment.

Regulatory compliance: Most modern debinding fluids are not a hazardous air pollutant (HAP).  Many do not require National Emission Standards for Hazardous Air Pollutants (NESHAP) permits.

Safe for workers: The PEL (Permissible Exposure Limit), or OSHA-designated time limit that workers are exposed to a solvent, is about 200-250 ppm for modern debinding fluids. This is significantly better than TCE (100-ppm PEL) or nPB (0.1 ppm PEL). 

Environmentally sustainable:  Most modern debinding fluids have a low GWP (Global Warming Potential) under 10 and a zero Ozone Depleting Potential (ODP). This makes them better for overall air quality. Choosing an environmentally sustainable debinding fluid helps companies not only meet regulations today but prepares them to comply with evolving future regulations. In addition, when used in a vapor degreaser, modern debinding fluids are distilled, recycled, and reused, limiting environmental waste.

Metal 3D printing for the future

Metal 3D printing is changing quickly. Until recently it was used just for prototyping or low-volume runs because it was too expensive and too slow for mass production. But as a wider selection of part materials become available and as new software and hardware evolve, more companies are using metal 3D printing for higher production runs of medical devices. In addition, using modern debinding fluids brings operating efficiencies, cost savings and better environmental sustainability to the metal 3D printing processes of the future.

Work with an Expert

Debinding fluid is an important tool for successful 3D printed medical device manufacturing. Fortunately, there are a number of good modern debinding fluid choices that not only debind effectively but are also safer for people and gentler on the planet.  Companies looking for help in determining the right debinding fluid or method should consult with a critical cleaning partner that specializes in vapor degreaser debinding. Some fluid manufacturers have field engineers that conduct on-site audits to evaluate debinding methods and can also perform comprehensive in-lab tests with sample parts to ensure which debinding fluid works best.

 

Venesia Hurtubise is a Technical Chemist at MicroCare Medical which offers medical device cleaning, coating, and lubricating solutions. She has been in the industry for more than 5 years and holds an MS in Green Chemistry from Imperial College London. Hurtubise researches, develops, and tests cleaning-related products that are used on a daily basis in medical and precision cleaning applications. For more information, visit www.microcaremed.com.

Abbott Gains EUA for $5, 15-Minute COVID-19 Antigen Test

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FDA has issued an Emergency Use Authorization (EUA) for Abbott’s BinaxNOW COVID-19 Ag Card for rapid detection of COVID-19 infection, the company reported in a news release. Described as being about the size of a credit card, the test is priced at $5 and can generate results in 15 minutes, Abbott reported.

The BinaxNOW COVID-19 Ag Card utilizes Abbott’s lateral flow technology, and testing professionals do not need equipment for sample processing. The EUA authorizes the test to be used by healthcare professionals in point-of-care settings that are qualified to perform the test. The test can also be used by professionals in near-patient settings.

Abbott has now launched six tests to address the coronavirus pandemic. In addition to the BinaxNOW COVID-19 Ag Card, the company launched molecular diagnostic tests for its ID Now rapid point-of-care platform,  its M2000 laboratory platform, and its Alinity m molecular laboratory systems; it also launched antibody tests for its high-throughput ARCHITECT i1000SR and i2000SR and Alinity i laboratory instruments.

Along with the BinaxNOW COVID-19 Ag Card, Abbott is also debuting NAVICA, a complementary mobile app for iPhone and Android devices that either displays negative results from the test through a temporary digital health pass or messages patients with positive test results to quarantine and talk to their doctor.

"We intentionally designed the BinaxNOW test and NAVICA app so we could offer a comprehensive testing solution to help Americans feel more confident about their health and lives," said Robert B. Ford, president and chief executive officer, Abbott, in the release. "BinaxNOW and the NAVICA app give us an affordable, easy-to-use, scalable test, and a complementary digital health tool to help us have a bit more normalcy in our daily lives."

Added Charles Chiu, M.D., Ph.D., professor of Laboratory Medicine at University of California, San Francisco, in the release: "Our nation's frontline healthcare workers and clinical laboratory personnel have been under siege since the onset of this pandemic. The availability of rapid testing for COVID-19 will help support overburdened laboratories, accelerate turnaround times, and greatly expand access to people who need it."

Image courtesy of AbbottAbbott BinaxNOW COVID-19 Ag Card

Above: The BinaxNOW COVID-19 Ag Card kit

 

Data from Abbott’s clinical study with several leading U.S. research universities show that the BinaxNOW COVID-19 Ag Card has a sensitivity of 97.1% (positive percent agreement) and a specificity of 98.5% (negative percent agreement) in patients suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset, according to the release.

Abbott plans to ship tens of millions of tests starting in September and expects to reach 50 million tests a month at the beginning of October, it reported.

7 Cases of Companies Altering Focus Because of COVID-19

The onset of the COVID-19 pandemic has no doubt caused things to shift throughout the world. Sports are handled differently – played in front of empty arenas and in some cases virtual audiences. 

Some restaurants only have drive-thru available. Things aren’t quite the same. Society and businesses have had to pivot in order to survive COVID-19.

The medtech industry is no different. Firms are in a period of reinvention and trying new things. Companies are branching out to become relevant and thrive in this new atmosphere. 

MD+DI has compiled a list of companies that have either altered plans or changed business practices to tackle the new normal COVID-19 presents.