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NeuroPace RNS System Receives FDA Approval for MRI Labeling, Allowing Thousands More Patients to Benefit from Personalized, Data-Driven Epilepsy Treatment

NeuroPace, Inc., a Silicon Valley-based medical technology company, today announced that its RNS® System has received U.S. Food and Drug Administration (FDA) approval of MRI labeling for the RNS System, expanding treatment options for the approximately one million patients in the United States living with seizures that do not respond to medication.

Individuals with focal onset seizures that also have brain anomalies that require monitoring, such as tuberous sclerosis, brain tumors or multiple sclerosis, as well as those with non-brain MRI requirements, can now be offered the RNS System as a treatment option. This will also allow people to receive the RNS System before committing to an irreversible surgery such as laser ablation, while keeping their future treatment options open.

“MRI conditional labeling opens up valuable medical imaging possibilities for our patients treated with the model RNS-320 neurostimulator, who can now receive full-body 1.5T magnetic resonance imaging (MRI) scans under appropriate conditions,” said Michael Favet, President and CEO of NeuroPace. “I’m pleased that we have removed a potential barrier to treatment and increased the number of patients who can benefit from this life-changing therapy.”

“The approval decision is wonderful news for the many people living with refractory epilepsy. This therapy not only reduces seizures, it also empowers clinicians with data-driven insights into their patients’ epilepsy,” said David Burdette, M.D., section chief of epilepsy at Spectrum Health, Grand Rapids, Michigan.

Treatment with the RNS System has been shown in a real-world, multi-center retrospective study to deliver outcomes never before seen with any neuromodulation device for epilepsy. Patients saw median seizure frequency reduction of 82% at 3 years, and 1 in 3 patients achieved 90% or greater seizure reduction.1 In addition to therapeutic benefits, the RNS System is the only epilepsy treatment that captures direct, real-world EEG data, enabling clinicians to personalize and optimize therapy over time.

Coronavirus News: Mologic Awarded c.£1 Million by UK Government to Develop Rapid Diagnostic Test

Mologic Ltd today announced that it has been awarded circa £1 million by the Wellcome Trust and the Department for International Development (DFID), as part of the UK government’s £46 million international coronavirus (COVID-19) prevention and research funding package.

The funding will be used by Mologic and global partners, to develop a point-of-need diagnostic test for the virus, in addition to supporting the Company to initiate research for novel vaccine candidates.

Mologic will build on their experience developing a rapid test kit for Ebola, which was also jointly funded by UK aid and the Wellcome Trust, to create a new hand-held diagnostics device to detect COVID-19. This will allow health officials to test for the virus at home or in the community, providing results in 10 minutes, without the need for electricity or a laboratory. Rapid identification of the virus enables quicker quarantine and access to care, to support global efforts in preventing further spread – especially in vulnerable countries that have limited specialist facilities. Alongside their work on diagnostics, UK aid is also supporting Mologic in the development of a COVID-19 vaccine candidate for further evaluation.

The company is working in close partnership with the Institut Pasteur de Dakar to validate and manufacture the COVID-19 test at a new manufacturing site, DiaTropix, in Senegal. This will be the first time that a diagnostics kit created in the UK will be jointly manufactured in Africa, to ensure its immediate availability, to manage any potential outbreaks on the continent and further international spread. Global validation partners include; Liverpool School of Tropical Medicine and St George’s, the University of London in Europe; the Wuhan Institute of Virology and the University of Malaya in Asia; and for Latin America, Fiocruz.

Professor Paul Davis, Co-Founder and Chief Scientific Officer, Mologic, commented: “As seen with the COVID-19 outbreak, viruses can quickly transmit between populations, however, our knowledge to tackle this threat has also grown exponentially. For rapid epidemic preparedness and response, we need to develop a platform that is readily modified according to a novel pathogen, as we are demonstrating through our accelerated programs for Ebola and COVID-19.”

Dr. Joe Fitchett, Medical Director, Mologic, said: “The COVID-19 outbreak is at a critical juncture, and to bring it to an end, we need next-generation diagnostics for use at the point-of-need – at home or in the community, in limited and well-resourced settings. Rapid detection of the virus is important to stop its spread – we are pleased that the UK government has acknowledged this, supporting Mologic and the work of our partners to prevent further outbreaks internationally.”

Dr Amadou Sall, Director of Institut Pasteur de Dakar, said: “The COVID-19 epidemic highlights an unprecedented level of seeding of cases to vulnerable locations. We are proud of this partnership working with UK aid to support all countries to have responsive and resilient diagnostics to control COVID-19. With Mologic, we are already applying for support from the UK government and Wellcome Trust to develop successful diagnostics tests to detect and combat the spread of Ebola, which is close to being controlled in the Democratic Republic of the Congo. DiaTropix’s remit is to responsively manufacture diagnostics for epidemics both for Africa and wherever they surface.”

Bashir Endovascular Catheter First-In-Human Trial for Acute Pulmonary Embolism Confirms Early Safety and Feasibility and Impressive Reduction of Clot Burden

Thrombolex, Inc. is a medical device company that focuses on the design, development and manufacture of innovative endovascular therapies for the treatment of arterial and venous thromboembolic disorders.

Recently they announced that its First-In-Human (FIH) trial confirms the early safety and feasibility of using the Bashir® Endovascular Catheter for pharmaco-mechanical catheter-directed thrombolysis (CDT) in patients with acute pulmonary embolism (PE). The data was presented at the American Venous Forum (AFV) Annual Meeting in Amelia Island, FL.  The data showed a significant reduction in right ventricular to left ventricular (RV/LV) diameter ratio and clot burden.

Akhilesh Sista, MD, FSIR, FAHA, Thrombolex FIH study Co-Principal Investigator, Chief of Vascular and Interventional Radiology at NYU-Langone School of Medicine, and vice-chair of the recently published Interventional Therapies for Acute Pulmonary Embolism guidelines from the American Heart Association notes, “The results from the First-in-Human study for the Bashir Endovascular Catheter are exciting — the PE patients treated were real-world patients that had high thrombus burden and major right ventricular dilation. The amount of thrombus removed with less than 14 mg of tissue plasminogen activator (r-tPA) was impressive.” He added, “I look forward to seeing what this device can do in a larger study and a randomized cohort.”

The Thrombolex FIH trial was a prospective, single-arm, multicenter study conducted under an Investigational New Drug (IND) assignment from the U.S. Food and Drug Administration (FDA) that evaluated the safety and feasibility of the Bashir® Endovascular Catheter in the treatment of patients with acute pulmonary embolism (ClinicalTrials.gov Identifier NCT03927508). The study enrolled 9 participants across 4 U.S. study centers.

The Thrombolex FIH study demonstrated excellent safety, as there were no drug or devicerelated adverse events, as adjudicated by the Data Safety Monitor. The primary feasibility endpoints were met with a significant mean reduction in right ventricular to left ventricular (RV/LV) diameter ratio. The RV/LV ratio decreased from 1.52 ± 0.26 pre-procedure to 0.97 ± 0.06 (p=0.0009), corresponding to a 36.7 % reduction, at 48 hours after intervention. Likewise, the Modified Miller Index (MMI) demonstrated a decreased from 25.4 ± 5.3 pre-procedure to 16.0 ± 4.0 at 48 hours (p=0.0005), corresponding to a 37.1% reduction, after a mean dose of 13.6 mg of r-tPA over 8 hours. “The innovative design of the Bashir Endovascular Catheter enables it to engage and fissure the thrombus, as well as deliver fibrinolytic throughout the entire crosssectional volume of the clot. In theory, this potentially allows for more prompt restoration of flow to the lungs and relief of right ventricular overload. The results of this EFS study appear to corroborate this mechanism of action. We look forward to further evidence of this effect in a larger cohort”, said Kenneth Rosenfield, MD, FACC, MSCAI, Thrombolex FIH Co-Principal Investigator, co-founder of the PERT Consortium, Interventional Cardiologist and Section Head for Vascular Medicine and Intervention, Massachusetts General Hospital.

Both the reduction in RV/LV ratio and the reduction in clot burden as measured by the MMI score compare very favorably with what has been published in ultrasound-assisted catheter-directed thrombolysis and mechanical thrombectomy device trials. This study will be followed by a much larger pivotal trial in patients with acute pulmonary embolism. “We are excited about the excellent results of our FIH trial, which has demonstrated prompt restoration of blood flow with rapid clot dissolution and reduced RV strain. We look forward to collaborating with physicians who work in this field to bring better treatment options to patients”, commented Marv Woodall, Chairman & CEO.

FDA Clearance and U.S. Launch of Innovative Nonsurgical Procedure for Chronic Rhinitis

The RhinAer™ Stylus is an innovative device for nonsurgical treatment of chronic rhinitis.

Aerin Medical notes more than 30 million Americans suffer from nonallergic rhinitis.1 Patients with the condition suffer from a runny nose, post-nasal drip, congestion, chronic cough, and other symptoms. For many patients, management with medications and sprays is inadequate. The RhinAer procedure provides lasting relief by directly disrupting the signals that cause symptoms. The procedure can be performed under a local anesthetic in an ENT physician’s office, with no incisions and minimal discomfort.

“Chronic rhinitis can significantly affect quality of life and impact daily activities,” said Adil A. Fatakia, M.D., a rhinologist at West Jefferson Medical Center in Marrerro, La. “The RhinAer procedure’s compelling clinical results, including its high responder rate, clean side effect profile, and tolerability, make it a highly attractive option for my patients.”

Clinical results from the prospective, multi-center pivotal clinical trial of the RhinAer Stylus demonstrated meaningful benefits to patients. In the study, 96% of patients treated with the RhinAer procedure reported an improvement in their rhinitis symptoms at six months, with symptoms improving on average by 61%. The procedure was safe and generally well-tolerated. Notably, significant improvements were demonstrated for runny nose and post-nasal drip, the most bothersome chronic rhinitis symptoms.

“The FDA clearance and launch of our second nonsurgical innovation for ENT physicians and patients is a significant milestone for Aerin,” said Fred Dinger, President and CEO. “More than 13,000 patients with nasal airway obstruction have now been treated with our first product, the VivAer® Stylus with the Aerin™ Console. With the addition of the RhinAer Stylus we now offer ENT physicians a platform solution that can be used to improve the lives of the millions of patients suffering from chronic rhinitis.”

Both procedures rely on Aerin’s proprietary temperature-controlled technology, which has been developed and optimized for the nasal airway to provide a precise therapeutic effect while minimizing risk to surrounding tissue.

References

1 Scarupa MD, Kaliner MA. Nonallergic rhinitis, with a focus on vasomotor rhinitis: clinical importance, differential diagnosis, and effective treatment recommendations. World Allergy Organ J. 2009; 2(3):20-25. doi:10.1097/WOX.0b013e3181990aac.

Okami Medical Announces First Patients Treated With The LOBO Vascular Occluder

The LOBO (LOw-profile Braided Occluder) system is uniquely designed to provide interventional physicians with a single-device, one-and-done solution for the occlusion of various arterial targets without the need for multiple embolic devices.

Okami Medical advises the LOBO system combines a patented design with proprietary HDBRAIDTM technology to create a highly occlusive pore structure that substantially reduces blood flow and accelerates vessel closure.  The LOBO-3 occluder is intended for use in 1.5 to 3 mm diameter vessels.

Dr. Ripal Gandhi, Interventional Radiologist, Miami Cardiac and Vascular Institute, performed the first LOBO-3 implant.  “We have successfully utilized the LOBO-3 occluder to embolize several small vessels via a microcatheter.  The device has resulted in immediate occlusion of the target vessels.  The device tracks well and deploys precisely at the desired location.  The LOBO-3 occluder is a great addition to the embolic armamentarium for the occlusion of small vessels,” said Dr. Gandhi.

“Guided by world-class physician collaborators, Okami is committed to addressing numerous challenging aspects of peripheral vascular occlusion,” said Bob Rosenbluth, Ph.D., President, and CEO of Okami Medical.  “We are very pleased with the clinical performance of the LOBO-3 occluder in the initial cases.  The device is in clinical use at key centers and we look forward to expanding our launch in 2020.”

Magnolia Medical Announces (FDA) 510(k) Clearance of New Configurations and the Entire Steripath® Gen2 Initial Specimen Diversion Device® Product Family

Extensive clinical data demonstrating the performance achieved with Steripath was evaluated by the FDA. This data included peer-reviewed controlled studies published in leading medical journals including Clinical Infectious Diseases1 (CID) and the Journal of Emergency Nursing2 (JEN) demonstrating significant reductions in blood culture contamination with Steripath compared to standard method controls.

At the University of Nebraska Medical Center (UNMC), Steripath demonstrated an 88% reduction in blood culture contamination down to 0.2% in the Emergency Department compared to standard method controls sustained for the one-year study period. This performance represented a 92% reduction compared to the pre-intervention period.

Steripath performance across four Lee Health Emergency Departments over a 7-month study period spanning 41,685 blood cultures demonstrated an 83% reduction in blood culture contamination compared to standard method controls with both venipuncture and IV-start configurations of Steripath Gen2.

These clinical results supported Steripath’s FDA-cleared indications for use to reduce the frequency of blood culture contamination when contaminants are present, compared to standard method controls without diversion. Additionally, components of the Steripath Gen2 system may be used for infusion following sample collection, consistent with the Instructions for Use.3

Steripath is the first and only cleared device indicated to reduce blood culture contamination.

“As the inventors of the blood culture diversion device category, we have focused heavily on development of robust clinical data to demonstrate the sustained performance of Steripath,” said Greg Bullington, CEO of Magnolia Medical. “We appreciate the rigor of the FDA review process that resulted in this clearance and specific indications for use.”

The patented Steripath Gen2 ISDD® platform integrates user-controlled negative pressure to divert and sequester the initial 1.5 to 2.0 mL of blood collected for culture, the portion known to most likely contain contaminants.4 The device has been demonstrated effective for use with blood cultures drawn via both venipuncture and peripheral IV starts.2

Each year, tens of millions of patients in the U.S. require a blood culture test for diagnosis of sepsis and other bloodstream infections. On average, 3% of these tests are false-positive due to contamination.5 These false-positive results place over 1.2 million patients at risk of misdiagnosis for sepsis.6

Steripath is a clinically proven solution to address this significant hidden problem in healthcare – the misdiagnosis of sepsis. Improving the accuracy of diagnostic test results for sepsis may reduce unnecessary antibiotic treatment to address the growing threat of antibiotic-resistance and reduce hospital costs.

References

  1. M. Rupp, et al. Clinical Infectious Diseases (2017)
  2. M. Bell, et al. Journal of Emergency Nursing (2018)
  3. See full Instructions for Use included in device packaging
  4. Patton, R., et al. Journal of Clinical Microbiology (2010)
  5. Zwang, O., et al. Journal of Hospital Medicine (2006)
  6. Patton, R., et al. Infection Control & Hospital Epidemiology (2016)

Supira Medical, A Shifamed Portfolio Company, Closes $35M In Series B Financing

Supira Medical notes the funds will be used to advance product development and clinical efforts for the company’s next-generation percutaneous ventricular assist device (pVAD).

Additionally, Supira Medical announced the appointment of seasoned medical device executive, Dr. Nitin Salunke, as President and Chief Executive Officer.

“Supira’s innovative approach could potentially provide a meaningful clinical solution for patients requiring temporary mechanical support during coronary interventions,” stated Bihua Chen, Founder and Managing Member of Cormorant Asset Management. “Despite advances in PCI, a large unmet need exists for high-risk patients and we are excited to lead and further invest in Supira Medical.”

Percutaneous ventricular assist devices (pVADs) are used during stent placement or angioplasty to provide temporary mechanical support for patients with severe coronary artery disease or comorbidities. Additionally, pVADs are used to treat patients suffering from cardiogenic shock (CS), a condition that can occur following a severe heart attack, and is associated with a high rate of morbidity as a patient’s heart is suddenly too weak to adequately pump blood to vital organs.

“Temporary mechanical support provides many patients with the option to undergo coronary interventions that their heart would otherwise not be healthy enough to endure,” stated Nitin Salunke. “I am pleased to join the Supira team as we advance pVAD technology with a low-profile, high-flow solution that aims to improve outcomes for these high-risk patients.”

Nitin brings over two decades of medical device development and leadership experience to Supira Medical. Previously, he served as Vice President of Research and Development for Medtronic’s Neurovascular business and a member of its management board. In this role, Nitin was responsible for the strategic growth through new product development for the global business, which included therapies for treating ischemic and hemorrhagic strokes. Prior to Medtronic, Nitin served as the Vice President of Research and Development at Altura Medical (acquired by Lombard Medical), as well as Director of Research and Development Engineering at Cordis Corp, a Johnson and Johnson company (acquired by Cardinal Health). Early in his career, Nitin was with W.L. Gore & Associates, holding roles of increasing responsibility within new product development, engineering operations and marketing. Nitin is an inventor/co-author of several patents and publications. Nitin holds a Ph.D. in Mechanical Engineering, with research focus in Cardiovascular Biomechanics, from the University of Maryland Baltimore County.  Additionally, he holds an MS from the University of Oklahoma and an Executive MBA from San Jose State University.

“I am delighted to have Nitin join and lead Supira at this important time. His strong medical device experience and leadership skills make him an ideal fit to spearhead the company towards its first clinical milestone,” commented Amr Salahieh, Founder of Shifamed and Chairman of Supira Medical. “The closing of this significant financing round speaks to the large, unmet need Supira’s technology will address.”

Other funding news items can be found here.

ASET Foot Plating System Released by TriMed

The ASET Foot Plating System offers unique implants to treat MTP fusions, Lapidus fusions, and TMT fusions. In addition, the system’s variety of patented Hook Plates provide additional points of fixation to bones of limited real estate without relying on thread purchase.

ASET’s instrumentation allows surgeons to control compression at the fracture, fusion, or osteotomy site with the use of the patented Expander/Compression tool, dubbed by surgeons as the ‘Magic Screwdriver’. This ability to apply surgeon-controlled compression (SCC) allows the surgeon to feel and apply the desired compression at the fusion site.

The entire array of ASET System plates are designed to accept all three sized screws (2.7, 3.5, and 4.0mm) to fit in any screw hole, reducing the need for additional inventory. All locking screws are designed to sit flush with the plate even when angled 15 degrees in either direction.

Greg Tsarukian, Senior Product Manager, emphasized that the ASET Foot Plating System is advantageous for challenging indications such as mid-foot fusions because of the unique implants, screws, and instruments. “The set’s instruments are user-friendly and intuitive, including the Magic Screwdriver tool. There is a variety of choices of locking and cortical screws that fit into all plates while using the one-size driver. All of the plates are low profile, and their screw holes offer the ability of a variable angle of up to 15°. ASET offers plenty of options in case of in-surgery revisions,” he added.

BD Announces BD Kiestra ReadA is Now Available to U.S. Clinical Microbiology Laboratories

The BD Kiestra ReadA provides closed door incubation and high throughput imaging to streamline workflow, delivering high quality images for digital interpretation by laboratory staff.

By reducing the time spent sorting plates combined with high resolution imaging, the system helps enhance operational efficiency and may reduce time to result.

“Building on the landmark CE marking of BD Kiestra™ IdentifA in November, we continue to execute on our strategy of modular laboratory automation solutions. The BD Kiestra™ ReadA instrument is a first-to-market solution that will enable new customers to enter microbiology lab automation at the incubation and imaging step,” said Steve Conly, vice president of microbiology at BD. “The system transforms the manual, hands-on workflow of plate-reading to one that is automated and digital.”

Powered by BD Synapsys™ microbiology informatics solution, the BD Kiestra™ ReadA also provides on-demand patient summary overviews, allowing lab staff to access actionable information from anywhere, any time.

BD continues to invest in automation and innovation for the microbiology laboratory. For more information on BD Kiestra™ lab automation solutions, please visit https://www.bd.com/en-us/offerings/capabilities/lab-automation.

 

Luminex Provides Updates on Critical Efforts Related to Novel Coronavirus

“We have been working on multiple solutions to augment our NxTAG and ARIES offerings in order to facilitate and automate the detection of SARS-CoV-2,” said Nachum “Homi” Shamir, President and CEO of Luminex.

Shamir added, “These additional alternatives leverage our globally available instrument platforms and assay technologies. They should be especially helpful to laboratories throughout the United States, given the recently released guidance from the Food and Drug Administration concerning high-complexity testing under CLIA prior to Emergency Use Authorization (EUA) for SARS-CoV-2.”

Luminex anticipates making two different solutions available for SARS-CoV-2 testing:

  1. NxTAG® CoV Expanded Panel. Luminex has developed a unique multiplex panel that addresses the current coronavirus outbreak using its existing bead-based NxTAG Technology. This expanded panel has undergone initial testing using samples at Chinese Center for Disease Control and Prevention (China CDC) locations. Early results seem very promising and the company expects to conclude this testing in the next several days. In addition, Luminex has begun validation in the United States at a number of existing customer facilities. This panel should be available to ship to customers in a few weeks, under the terms of the EUA listed above. 

    This expanded panel includes three gene targets for SARS-CoV-2 (ORF, E-gene, and N-gene), as well as SARS-CoV and MERS-CoV, and will be the first assay panel globally that will be able to simultaneously test for each of these coronavirus strains. Luminex’s NxTAG® Respiratory Pathogen Panel (RPP), which was cleared by the FDA and other worldwide agencies more than four years ago, can be run in parallel with the expanded outbreak panel to identify and/or rule out both existing and novel respiratory infections. The existing RPP test and this new expanded panel are both plate-based, high-throughput, low-cost solutions that run on the MAGPIX® instrument. This combination of assays offers labs an ideal solution for their anticipated high-volume testing of respiratory infections, including both flu and other coronaviruses.
  2. SARS-CoV-2 Target on ARIES®. In addition, Luminex has evaluated a single-target test on the ARIES® System for SARS-CoV-2. The company has had two European reference labs successfully validate a multi-targeted test using the ARIES® System and are also currently validating the test with customers in the United States. ARIES® uses real-time PCR technology that, when combined with its ability to run laboratory developed tests (LDTs), is ideally suited for situations such as the current pandemic. This SARS-CoV-2 target incorporates the latest U.S. Centers for Disease Control and Prevention (CDC) primer sequences and is currently available to customers who use the ARIES® System. This testing can be validated by qualifying laboratories under the aforementioned EUA path. The ARIES® System currently has seven FDA cleared assays, including Flu A/B & RSV.

“Offering multiple solutions is a key part of Luminex’s focus on providing value and flexibility to our current and future customers,” said Shamir. “The assays we are working on will assist both laboratories and clinicians that need to detect SARS-CoV-2 on its own, as well as those that may need a more complete picture of potential causes of respiratory infections—including targets that are both common and novel in nature. In addition, Luminex’s VERIGENE® RP Flex Test, NxTAG RPP, and ARIES® Flu A/B & RSV assays are all able to provide exclusion testing as laboratories grapple with the emerging COVID-19 situation during the flu/respiratory season. Given the expanding scope of this outbreak, it seems likely that we could be battling COVID-19 for the foreseeable future.

“We are unable to quantify at this time what, if any, material financial impact these efforts will have, and are not making any adjustments to our current expectations.  We look forward to providing additional updates as they become available,” said Shamir.

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