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Archive for the ‘Medical Devices R&D and Inventions’ Category

New avenues for research in membrane biology reveals the mobility of protein at work

Curator and Reporter: Dr. Premalata Pati, Ph.D., Postdoc

Membrane proteins (MPs) are proteins that exist in the plasma membrane and conduct a variety of biological functions such as ion transport, substrate transport, and signal transduction. MPs undergo function-related conformational changes on time intervals spanning from nanoseconds to seconds. Many MP structures have been solved thanks to recent developments in structural biology, particularly in single-particle cryo-Electron Microscopy (cryo-EM). Obtaining time-resolved dynamic information on MPs in their membrane surroundings, on the other hand, remains a significant difficulty.

OmpG (Open state) in a fully hydrated dimyristoylphosphatidylcholine (DMPC) bilayer. The protein is shown in light green cartoon. Lipids units are depicted in yellow, while their phosphate and choline groups are illustrated as orange and green van der Waals spheres, respectively. Potassium and chloride counterions are shown in green and purple, respectively. A continuous and semi-transparent cyan representation is used for water.
https://static-content.springer.com/esm/art%3A10.1038%2Fs41467-021-24660-1/MediaObjects/41467_2021_24660_MOESM1_ESM.pdf

Weill Cornell Medicine (WCM) researchers have found that they can record high-speed protein movements while linking them to function. The accomplishment should allow scientists to examine proteins in more depth than ever before, and in theory, it should allow for the development of drugs that work better by hitting their protein targets much more effectively.

The researchers utilized High-Speed Atomic Force Microscopy (HS-AFM) to record the rapid motions of a channel protein and published in a report in Nature Communications on July 16. Such proteins generally create channel or tube-like structures in cell membranes, which open to allow molecules to flow under particular conditions. The researchers were able to record the channel protein’s rapid openings and closings with the same temporal resolution as single channel recordings, a typical technique for recording the intermittent passage of charged molecules through the channel.

Senior author Simon Scheuring, professor of physiology and biophysics in anesthesiology at WCM, said,

There has been a significant need for a tool like this that achieves such a high bandwidth that it can ‘see’ the structural variations of molecules as they work.

Researchers can now produce incredibly detailed photographs of molecules using techniques like X-ray crystallography and electron microscopy, showing their structures down to the atomic scale. The average or dominant structural positionings, or conformations, of the molecules, are depicted in these “images,” which are often calculated from thousands of individual photos. In that way, they’re similar to the long-exposure still photos from the dawn of photography.

Many molecules, on the other hand, are flexible and always-moving machinery rather than fixed structures. Scientists need to generate videos, not still photos, to reveal how such molecules move as they work, to see how their motion translates to function to catch their critical functional conformations, which may only exist for a brief moment. Current techniques for dynamic structural imaging, on the other hand, have several drawbacks, one of which being the requirement for fluorescent tags to be inserted on the molecules being photographed in many cases.

Scheuring and his lab were early adopters of the tag-free HS-AFM approach for studying molecular dynamics. The technology, which can photograph molecules in a liquid solution similar to a genuine cellular environment, employs an extremely sensitive probe, similar to a record player’s stylus, to feel its way over a molecule and therefore build up a picture of its structure. Standard HS-AFM isn’t quick enough to capture the high-speed dynamics of many proteins, but Scheuring and colleagues have developed a modified version, HS-AFM height spectroscopy (HS-AFM-HS), that works much faster by collecting dynamic changes in only one dimension: height.

The researchers used HS-AFM-HS to record the opening and closing of a relatively simple channel protein, OmpG, found in bacteria and widely studied as a model channel protein in the new study, led by the first author Raghavendar Reddy Sanganna Gari, a postdoctoral research associate in Scheuring’s laboratory. They were able to monitor OmpG gating at an effective rate of roughly 20,000 data points per second, seeing how it transitioned from open to closed states or vice versa as the acidity of the surrounding fluid varied.

More significantly, they were able to correlate structural dynamics with functional dynamics in a membrane protein of this size for the first time in a partnership with Crina Nimigean, professor of physiology and biophysics in anesthesiology, and her group at WCM.

The demonstration opens the door for a wider application of this method in basic biology and drug development.

Sanganna Gari stated,

We’re now in an exciting period of HS-AFM technology, for example using this technique to study how some drugs modulate the structural dynamics of the channel proteins they target.

Main Source

Technique reveals proteins moving as they work. By Jim Schnabel in Cornell Chronicle, August 16, 2021.

https://news.cornell.edu/stories/2021/08/technique-reveals-proteins-moving-they-work

Other Related Articles published in this Open Access Online Scientific Journal include the following:

Cryo-EM disclosed how the D614G mutation changes SARS-CoV-2 spike protein structure.

Reporter: Dr. Premalata Pati, Ph.D., Postdoc

https://pharmaceuticalintelligence.com/2021/04/10/cryo-em-disclosed-how-the-d614g-mutation-changes-sars-cov-2-spike-protein-structure/

Proteins, Imaging and Therapeutics

Larry H Bernstein, MD, FCAP, Curator, LPBI

https://pharmaceuticalintelligence.com/2015/10/01/proteins-imaging-and-therapeutics/

From High-Throughput Assay to Systems Biology: New Tools for Drug Discovery

Curator: Stephen J. Williams, PhD

https://pharmaceuticalintelligence.com/2021/07/19/from-high-throughput-assay-to-systems-biology-new-tools-for-drug-discovery/

Imaging break-through: Fusion of microscopy and mass spectrometry produces detailed map of protein distribution

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2015/03/18/imaging-break-through-fusion-of-microscopy-and-mass-spectrometry-produces-detailed-map-of-protein-distribution/

Advanced Microscopic Imaging

Larry H Bernstein, MD, FCAP, Curator, LPBI

https://pharmaceuticalintelligence.com/2016/02/07/advanced-microscopic-imaging/

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Patients with type 2 diabetes may soon receive artificial pancreas and a smartphone app assistance

Curator and Reporter: Dr. Premalata Pati, Ph.D., Postdoc

In a brief, randomized crossover investigation, adults with type 2 diabetes and end-stage renal disease who needed dialysis benefited from an artificial pancreas. Tests conducted by the University of Cambridge and Inselspital, University Hospital of Bern, Switzerland, reveal that now the device can help patients safely and effectively monitor their blood sugar levels and reduce the risk of low blood sugar levels.

Diabetes is the most prevalent cause of kidney failure, accounting for just under one-third (30%) of all cases. As the number of people living with type 2 diabetes rises, so does the number of people who require dialysis or a kidney transplant. Kidney failure raises the risk of hypoglycemia and hyperglycemia, or unusually low or high blood sugar levels, which can lead to problems ranging from dizziness to falls and even coma.

Diabetes management in adults with renal failure is difficult for both the patients and the healthcare practitioners. Many components of their therapy, including blood sugar level targets and medications, are poorly understood. Because most oral diabetes drugs are not indicated for these patients, insulin injections are the most often utilized diabetic therapy-yet establishing optimum insulin dose regimes is difficult.

A team from the University of Cambridge and Cambridge University Hospitals NHS Foundation Trust earlier developed an artificial pancreas with the goal of replacing insulin injections for type 1 diabetic patients. The team, collaborating with experts at Bern University Hospital and the University of Bern in Switzerland, demonstrated that the device may be used to help patients with type 2 diabetes and renal failure in a study published on 4 August 2021 in Nature Medicine.

The study’s lead author, Dr Charlotte Boughton of the Wellcome Trust-MRC Institute of Metabolic Science at the University of Cambridge, stated:

Patients living with type 2 diabetes and kidney failure are a particularly vulnerable group and managing their condition-trying to prevent potentially dangerous highs or lows of blood sugar levels – can be a challenge. There’s a real unmet need for new approaches to help them manage their condition safely and effectively.

The Device

The artificial pancreas is a compact, portable medical device that uses digital technology to automate insulin delivery to perform the role of a healthy pancreas in managing blood glucose levels. The system is worn on the outside of the body and consists of three functional components:

  • a glucose sensor
  • a computer algorithm for calculating the insulin dose
  • an insulin pump

The artificial pancreas directed insulin delivery on a Dana Diabecare RS pump using a Dexcom G6 transmitter linked to the Cambridge adaptive model predictive control algorithm, automatically administering faster-acting insulin aspart (Fiasp). The CamDiab CamAPS HX closed-loop app on an unlocked Android phone was used to manage the closed loop system, with a goal glucose of 126 mg/dL. The program calculated an insulin infusion rate based on the data from the G6 sensor every 8 to 12 minutes, which was then wirelessly routed to the insulin pump, with data automatically uploaded to the Diasend/Glooko data management platform.

The Case Study

Between October 2019 and November 2020, the team recruited 26 dialysis patients. Thirteen patients were randomly assigned to get the artificial pancreas first, followed by 13 patients who received normal insulin therapy initially. The researchers compared how long patients spent as outpatients in the target blood sugar range (5.6 to 10.0mmol/L) throughout a 20-day period.

Patients who used the artificial pancreas spent 53 % in the target range on average, compared to 38% who utilized the control treatment. When compared to the control therapy, this translated to approximately 3.5 more hours per day spent in the target range.

The artificial pancreas resulted in reduced mean blood sugar levels (10.1 vs. 11.6 mmol/L). The artificial pancreas cut the amount of time patients spent with potentially dangerously low blood sugar levels, known as ‘hypos.’

The artificial pancreas’ efficacy improved significantly over the research period as the algorithm evolved, and the time spent in the target blood sugar range climbed from 36% on day one to over 60% by the twentieth day. This conclusion emphasizes the need of employing an adaptive algorithm that can adapt to an individual’s fluctuating insulin requirements over time.

When asked if they would recommend the artificial pancreas to others, everyone who responded indicated they would. Nine out of ten (92%) said they spent less time controlling their diabetes with the artificial pancreas than they did during the control period, and a comparable amount (87%) said they were less concerned about their blood sugar levels when using it.

Other advantages of the artificial pancreas mentioned by study participants included fewer finger-prick blood sugar tests, less time spent managing their diabetes, resulting in more personal time and independence, and increased peace of mind and reassurance. One disadvantage was the pain of wearing the insulin pump and carrying the smartphone.

Professor Roman Hovorka, a senior author from the Wellcome Trust-MRC Institute of Metabolic Science, mentioned:

Not only did the artificial pancreas increase the amount of time patients spent within the target range for the blood sugar levels, but it also gave the users peace of mind. They were able to spend less time having to focus on managing their condition and worrying about the blood sugar levels, and more time getting on with their lives.

The team is currently testing the artificial pancreas in outpatient settings in persons with type 2 diabetes who do not require dialysis, as well as in difficult medical scenarios such as perioperative care.

The artificial pancreas has the potential to become a fundamental part of integrated personalized care for people with complicated medical needs,” said Dr Lia Bally, who co-led the study in Bern.

The authors stated that the study’s shortcomings included a small sample size due to “Brexit-related study funding concerns and the COVID-19 epidemic.”

Boughton concluded:

We would like other clinicians to be aware that automated insulin delivery systems may be a safe and effective treatment option for people with type 2 diabetes and kidney failure in the future.

Main Source:

Boughton, C. K., Tripyla, A., Hartnell, S., Daly, A., Herzig, D., Wilinska, M. E., & Hovorka, R. (2021). Fully automated closed-loop glucose control compared with standard insulin therapy in adults with type 2 diabetes requiring dialysis: an open-label, randomized crossover trial. Nature Medicine, 1-6.

Other Related Articles published in this Open Access Online Scientific Journal include the following:

Developing Machine Learning Models for Prediction of Onset of Type-2 Diabetes

Reporter: Amandeep Kaur, B.Sc., M.Sc.

https://pharmaceuticalintelligence.com/2021/05/29/developing-machine-learning-models-for-prediction-of-onset-of-type-2-diabetes/

Artificial pancreas effectively controls type 1 diabetes in children age 6 and up

Reporter: Irina Robu, PhD

https://pharmaceuticalintelligence.com/2020/10/08/artificial-pancreas-effectively-controls-type-1-diabetes-in-children-age-6-and-up/

Google, Verily’s Uses AI to Screen for Diabetic Retinopathy

Reporter : Irina Robu, PhD

https://pharmaceuticalintelligence.com/2019/04/08/49900/

World’s first artificial pancreas

Reporter: Irina Robu, PhD

https://pharmaceuticalintelligence.com/2019/05/16/worlds-first-artificial-pancreas/

Artificial Pancreas – Medtronic Receives FDA Approval for World’s First Hybrid Closed Loop System for People with Type 1 Diabetes

Reporter: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2016/09/30/artificial-pancreas-medtronic-receives-fda-approval-for-worlds-first-hybrid-closed-loop-system-for-people-with-type-1-diabetes/

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Embryogenesis in Mechanical Womb

Reporter and Curator: Dr. Sudipta Saha, Ph.D.

A highly effective platforms for the ex utero culture of post-implantation mouse embryos have been developed in the present study by scientists of the Weizmann Institute of Science in Israel. The study was published in the journal Nature. They have grown more than 1,000 embryos in this way. This study enables the appropriate development of embryos from before gastrulation (embryonic day (E) 5.5) until the hindlimb formation stage (E11). Late gastrulating embryos (E7.5) are grown in three-dimensional rotating bottles, whereas extended culture from pre-gastrulation stages (E5.5 or E6.5) requires a combination of static and rotating bottle culture platforms.

At Day 11 of development more than halfway through a mouse pregnancy the researchers compared them to those developing in the uteruses of living mice and were found to be identical. Histological, molecular and single-cell RNA sequencing analyses confirm that the ex utero cultured embryos recapitulate in utero development precisely. The mouse embryos looked perfectly normal. All their organs developed as expected, along with their limbs and circulatory and nervous systems. Their tiny hearts were beating at a normal 170 beats per minute. But, the lab-grown embryos becomes too large to survive without a blood supply. They had a placenta and a yolk sack, but the nutrient solution that fed them through diffusion was no longer sufficient. So, a suitable mechanism for blood supply is required to be developed.

Till date the only way to study the development of tissues and organs is to turn to species like worms, frogs and flies that do not need a uterus, or to remove embryos from the uteruses of experimental animals at varying times, providing glimpses of development more like in snapshots than in live videos. This research will help scientists understand how mammals develop and how gene mutations, nutrients and environmental conditions may affect the fetus. This will allow researchers to mechanistically interrogate post-implantation morphogenesis and artificial embryogenesis in mammals. In the future it may be possible to develop a human embryo from fertilization to birth entirely outside the uterus. But the work may one day raise profound questions about whether other animals, even humans, should or could be cultured outside a living womb.

References:

https://www.nature.com/articles/s41586-021-03416-3

https://www.sciencedirect.com/science/article/pii/S0092867414000750?via%3Dihub

https://onlinelibrary.wiley.com/doi/abs/10.1111/j.1469-185X.1978.tb00993.x

https://www.nature.com/articles/199297a0

https://rep.bioscientifica.com/view/journals/rep/35/1/jrf_35_1_018.xml

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Left Ventricular Volume Reduction and Reshaping as a Treatment Option for Heart Failure

Reporter: Aviva Lev-Ari, PhD, RN

 

Left Ventricular Remodeling and Its Reversal

When the myocardium is subjected to abnormal mechanical and neurohormonal stresses, left ventricular remodeling ensues with a progression of structural, cellular, molecular, metabolic, and functional changes.

In chronic heart failure with reduced ejection fraction, this remodeling affects the left ventricle with consequences that include ventricular dilation, transition of the chamber shape from elliptical to spherical, and the shifting of papillary muscles and mitral valve apparatus into abnormal positions. Ironically, while remodeling is an outgrowth of the initial hemodynamic and metabolic insults that lead to heart failure, it is also self-propagating, contributing to the progressive loss of ventricular function over time.

In the July 20 online issue of Structural Heart, heart failure specialists at Columbia University Vagelos College of Physicians and Surgeons present a comprehensive review of treatment options that focus on restoring the normal ventricular size and preventing the remodeling process from continuing. But can preventing or limiting left ventricular remodeling following an insult or reversing it once it is present reduce cardiovascular morbidity?

Their article provides insight into this question with a view toward better understanding the impact of remodeling on ventricular dysfunction and an in-depth look at therapeutic approaches, including those that are well-established, several that are currently under investigation, as well as those that have been invalidated and no longer used. The authors focus on two fundamental therapeutic approaches – those that rely primarily on

  • biological mechanisms to induce responses in the myocardium and improve myocardial function, and
  • physical mechanisms, involving procedures where a portion of the heart is either removed or excluded and devices to reduce myocardial wall stress through ventricular constraint or reshaping.

Read more:

Left Ventricular Volume Reduction and Reshaping as a Treatment Option for Heart Failure.
https://doi.org/10.1080/24748706.2020.1777359

Other related articles published in this Open Access Online Scientific Journal, include the following:

Treatment Options for Left Ventricular Failure  –  Temporary Circulatory Support: Intra-aortic balloon pump (IABP) – Impella Recover LD/LP 5.0 and 2.5, Pump Catheters (Non-surgical) vs Bridge Therapy: Percutaneous Left Ventricular Assist Devices (pLVADs) and LVADs (Surgical) 

Author: Larry H Bernstein, MD, FCAP
and
Curator: Justin D Pearlman, MD, PhD, FACC

https://pharmaceuticalintelligence.com/2013/07/17/treatment-options-for-left-ventricular-failure-temporary-circulatory-support-intra-aortic-balloon-pump-iabp-impella-recover-ldlp-5-0-and-2-5-pump-catheters-non-surgical-vs-bridge-therapy/

Mechanical Circulatory Assist Devices as a Bridge to Heart Transplantation or as “Destination Therapy“: Options for Patients in Advanced Heart Failure

Writer and Curator: Larry H. Bernstein, MD, FCAP

and

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/06/30/advanced-heart-failure/

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Bioresorbable Stent Clinical Trials with New Esprit Below-the-knee Scaffold

Reporter: Irina Robu, PhD

Abbott announced on September 3, 2020, the beginning of the LIFE-BTK clinical trial to evaluate effectiveness and safety of  the Esprit BTK Everolimus Eluting Resorbable Scaffold System. The Esprit BTK System consists of a thin strutted scaffold made of poly-L-lactide, a semi-crystalline bioresorbable polymer engineered to resist vessel recoil and provide a platform for drug delivery. The scaffold is coated with poly-D, L-lactide (PDLLA) and the cytostatic drug, everolimus.

This trial is the first Investigational Device Exemption in the US to assess a fully bioresorbable stent to treat blocked arteries below the knees, also known as critical limb ischemia in people battling advanced stages of peripheral artery disease. For people with CLI, blocked vessels weaken blood flow to the lower extremities, which can lead to severe pain, wounds, and in severe cases, limb amputation.

At this time, the standard of care for patients battling critical limb ischemia is balloon angioplasty, which depend on on a small balloon delivered via a catheter to the blockage to compress it against the arterial wall, opening the vessel and restoring blood flow. Yet, blockages treated only with balloon angioplasty have poor short- and long-term results, and in many cases the vessels become blocked again, lacking additional treatment.

Patients treated with balloon angioplasty often require several procedures on treated arteries, and  a drug eluting resorbable device is if at all possible suited to provide mechanical support, decrease the chance of the vessel re-narrowing and then slowly disappear over time. At this time, there are no drug eluding stents, drug coated balloons or bare metal stents approved for use below the knee. Since, there is a limited number of options for stents below the knee, the FDA has granted Esprit BTK breakthrough device designation, which simplifies review and pre-market approval timelines.

According to Abbott, Espirit BTK System is not a permanent implant, but it does provide support to an artery right after a balloon angioplasty, stopping the vessel from reclosing. As soon as it is implanted, the scaffold distributes a drug over a few months that encourages healing and keeps the artery open. The scaffold is naturally resorbed into the body over time, like dissolving sutures, and eventually leaves only a healed artery behind.

The LIFE-BTK trial is the first Investigational Device Exemption trial in the U.S. to evaluate a fully dissoluble device to treat critical limb ischemia in people battling advanced stages of peripheral artery disease (PAD). The trial will be run by principal investigators Brian DeRubertis, M.D. (vascular surgeon, UCLA), Sahil Parikh M.D., (interventional cardiologist, New York-Presbyterian/Columbia University Irving Medical Center.

SOURCE

https://www.dicardiology.com/article/abbott-restarts-bioresorbable-stent-clinical-trials-new-esprit-below-knee-scaffold

 

 

 

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Targeting Atherosclerotic Plaques with Stents made of Drug-eluting Biomaterials

Reporter: Daniel Menzin, BSc BioMedical Engineering, expected, May 2021, Research Assistant 4, Core Applications Developer and Acting CTO 

 

Atherosclerosis is a chronic cardiovascular disease with a multitude of different implications. A coronary artery plaque may lead to congestive heart failure while an aortic plaque may cause angina. Both can quite possibly lead to a heart attack unless properly managed. One way to manage this condition is through the use of stents made of a mesh that is expanded following placement into the diseased vessel.

Unfortunately, stents are oftentimes initially effective but eventually restenosis occurs. Restenosis is a condition in which the affected vessel becomes blocked again. Cholesterol-rich blood vessel environments oftentimes lead to an irritation that results in white blood cells aggregating in the area and releasing proinflammatory chemokines and cytokines, which cause fibrosis. To make matters worse, the cholesterol plaques undergo compression against the vessel wall which causes vessel injury and further inflammation. This leads to thrombus formation and may potentiate neointimal hyperplasia, an abnormal proliferation and migration of smooth muscle cells in the tunica intima. Neointimal hyperplasia plays a major role in restenosis.

Recent research has found that interfacing drug eluting biomaterials with stents may help prevent restenosis. One study showed that rapamycin delivered with acid labile and ROS-sensitive forms of Beta-cyclodextrin produced promising results when treating atherosclerosis in rat models (Dou, et al). In this promising new paradigm of treatment, non-proinflammatory biomaterials are interfaced with stents. Once inflammation appears the biomaterial will begin to degrade, slowly releasing the drug which suppresses the underlying immune reaction and the resulting inflammation.

 

SOURCE

Dou Y;Chen Y;Zhang X;Xu X;Chen Y;Guo J;Zhang D;Wang R;Li X;Zhang J; “Non-Proinflammatory and Responsive Nanoplatforms for Targeted Treatment of Atherosclerosis.” Biomaterials, U.S. National Library of Medicine, 29 July 2017, pubmed.ncbi.nlm.nih.gov/28778000/.

 

Other related articles published in this Open Access Online Scientific Journal include: 

75 articles found in the search 

https://pharmaceuticalintelligence.com/?s=drug+eluting+stents

 

Among them:

Stent Design and Thrombosis:  Bifurcation Intervention, Drug Eluting Stents (DES) and Biodegrable Stents

Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/08/06/stent-design-and-thrombosis-bifurcation-intervention-drug-eluting-stents-des-and-biodegrable-stents/

 

Drug Eluting Stents: On MIT‘s Edelman Lab’s Contributions to Vascular Biology and its Pioneering Research on DES

Author: Larry H Bernstein, MD, FACP and Curator: Aviva Lev-Ari, PhD, RN

https://pharmaceuticalintelligence.com/2013/04/25/contributions-to-vascular-biology/

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First Surgical Robot Making Surgeon’s Life More Efficient

Reporter : Irina Robu, PhD

A team of microsurgeons and engineers, developed a high-precision robotic assistant called MUSA which is clinically and commercially available. The high precision robotic assistant is compatible with current operating techniques, workflow, instruments and other or instrument.   Microsure is a medical device company in The Netherlands founded by Eindhoven University of Technology and Maastricht University Medical Center in 2016. Microsure’s focus is to improve patients’ quality of life through developing robot systems for microsurgery.

The Microsure’s MUSA enhances surgical performance by stabilizing and scaling down the surgeon’s movements during complex microsurgical procedures on sub-millimeter scale. The surgical robot, allows lymphatic surgery on lymph vessels smaller than 0.3 mm in diameter. Microsure received the ISO 13485 certificate which assures that Microsure is adhering to the highest standards in quality management and regulatory compliance procedures to develop, manufacture, and test its products and services.

MUSA provides superhuman precision for microsurgeons, enabling new interventions that are currently impossible to perform by hand.

SOURCE

https://www.businesswire.com/news/home/20190607005175/en/

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New Neuromodulation Device to Treat Migraines

Reporter: Irina Robu, PhD

Theranica, Israeli startup is developing a non-invasive medical device that treats migraine pain through smartphone-controlled electric pulses unlike existing pharmaceutical solutions like triptans and ergotamine. The company recently received FDA De-novo clearance on Nerivio Migra, a class II medical device to treat acute migraine pain.

The non-invasive medical device, Nerivio Migra contains a bioelectric patch which is placed on the upper arm and a linked smartphone app which controls the electrical impulses and records data. The device’s electric pulses excite C-fiber nerves, generating an analgesic mechanism in the brain that lightens migraine pain.

In order to diminish the overuse of painkillers, the company developed the non-invasive device and tested it among acute migraine patients both two and 48 hours after treatment. Side effects from the device were mild and resolved within 24 hours.

Theranica’s product is lower in price than the existing alternatives and it is using existing smartphone technology. Their initial focus is on marketing to headache clinics as a start. And hoping to expand the indications for its device to the pediatric migraine population and finally use its platform to treat other idiopathic pain conditions like cluster headaches.

SOURCE

Israeli startup gets FDA nod for neuromodulation device to treat migraines

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Palmaz, Pinchuk, Schatz, Simpson and Yock are the 10th recipients of the Russ Prize for innovations leading to the widespread adoption of PCI at NAE Gala Ceremony, 2/20/2019, WashDC

 

Reporter: Aviva Lev-Ari, PhD, RN

National Academy of Engineering, Ohio University Award 2019 Russ Prize

Five interventional cardiologists awarded biennial $500,000 prize for innovations leading to the widespread adoption of PCI

National Academy of Engineering, Ohio University Award 2019 Russ Prize

January 3, 2019 — Ohio University and the National Academy of Engineering announced the 2019 Fritz J. and Dolores H. Russ Prize will be given to Julio Palmaz, Leonard Pinchuk, John Simpson, Richard Schatz and Paul Yock for innovations leading to the widespread adoption of percutaneous coronary intervention (PCI), also known as angioplasty with stent or coronary angioplasty. The $500,000 biennial prize, which recognizes a bioengineering achievement that significantly improves the human condition, cites PCI for “seminal contributions to coronary angioplasty, enabling minimally invasive treatment of advanced coronary artery disease.”

“The Russ Prize recipients personify engineering creations that advance health and healthcare every day,” said NAE President C. D. Mote, Jr.  “The PCI makes a remarkable contribution to patient well-being, helping millions afflicted with advanced coronary artery disease and significant angina. “

Ohio University alumnus and esteemed engineer Fritz Russ, BSEE ’42, HON ‘75, and his wife, Dolores Russ, established the biennial prize in 1999 with a multimillion dollar gift to Ohio University. They modeled it after the Nobel Prize, with the goal of recognizing bioengineering achievements worldwide that are in widespread use.

“This innovation — truly, sets of innovations — enables the treatment of coronary artery disease without the complexities, cost and risk of open heart surgery. Most of us have a friend or relative who has benefited greatly from angioplasty treatment,” said Russ College Dean Dennis Irwin. “These contributions have truly improved the human condition. Rewarding such innovations was the Russes’ intent.”

Percutaneous coronary intervention, also referred to as percutaneous transluminal coronary angioplasty (PTCA), is a minimally invasive procedure that uses a catheter to place a small structure called a stent to open up blood vessels in the heart that have been narrowed by plaque buildup. PCI improves blood flow, thus decreasing heart-related chest pain, making patients feel better and increasing their ability to be active. Ten of millions of patients have benefited from PCI worldwide, and this procedure has replaced or significantly delayed the need for open heart coronary bypass surgery.

Julio C. Palmaz, inventor of the first U.S. Food and Drug Administration (FDA)-approved balloon-expandable vascular stent (1990), is Ashbel Smith Professor at the University of Texas Health Science Center in San Antonio and scientific adviser of Vactronix Scientific. The Palmaz stent is on display at the Smithsonian’s National Museum of American History in Washington, D.C. In 1994 he and Richard Schatz created a modified coronary stent — two Palmaz stents joined by a single connector — approved by the FDA as the first stent indicated for the treatment of failure of coronary balloon angioplasty. The Palmaz-Schatz stent became the gold standard for every subsequent stent submitted for FDA approval.

Leonard Pinchuk is an inventor and entrepreneur in biomedical engineering, with 128 U.S. patents and 90 publications. He has co-founded 10 companies where his major accomplishments include invention of the Nylon 12 angioplasty balloon, helical wire stent, modular stent-graft, a drug-eluting stent (Taxus), several biomaterials (Bionate and polystyrene-block-isobutylene-block-styrene [SIBS]), a novel glaucoma tube (InnFocus MicroShunt), and the next-generation intraocular lens. He is a Distinguished Research Professor of Biomedical Engineering at the University of Miami.

John Simpson has helped revolutionize the field of cardiology through innovations that fundamentally altered how physicians treat cardiovascular disease. In 1981 he created a new catheter system for coronary angioplasty with an independently steerable guidewire in the central lumen of the balloon catheter, patented as the over-the-wire balloon angioplasty catheter. He now focuses his efforts on the treatment of vascular disease through the development of new technologies combined with a new approach to optical imaging.

Read the related article “Requirements for Interventional Echocardiographers”

Richard Schatz is research director of cardiovascular interventions at the Scripps Heart, Lung and Vascular Center, and director of gene and stem cell therapy. He is a recognized international expert in interventional cardiology and has published and lectured extensively. His seminal work in coronary stents spurred a revolution in the treatment of coronary artery disease — over 2 million of them are placed annually worldwide, with an immeasurable impact on relieving mortality and morbidity, improving patients’ lives, and reducing healthcare costs.

Paul Yock is the Martha Meier Weiland Professor of Medicine and founding co-chair of Stanford’s Department of Bioengineering, with courtesy appointments in the Graduate School of Business and the Department of Mechanical Engineering. He is also founder and director of the Stanford Byers Center for Biodesign. He has authored over 300 peer-reviewed publications, chapters, and editorials and two textbooks, and holds over 50 U.S. patents. Yock is internationally known for his work in inventing, developing and testing new devices, including the Rapid Exchange stenting and balloon angioplasty system, which is now the primary system in use worldwide. He also invented the fundamental approach to intravascular ultrasound imaging and founded Cardiovascular Imaging Systems (CVIS), later acquired by Boston Scientific.

“Ohio University is honored to join the National Academy of Engineering in recognizing these accomplished individuals, who have contributed to a bioengineering advancement that has enabled better health for heart patients across the world,” said Ohio University President M. Duane Nellis. “Their multi-disciplinary collaboration that lead to the development of PCI, a technology that has revolutionized coronary health, truly embraces the vision that Fritz and Dolores Russ had when creating the Russ Prize.”

Palmaz, Pinchuk, Schatz, Simpson and Yock are the 10th recipients of the Russ Prize. They will receive the award at a National Academy of Engineering gala ceremony in Washington, D.C., on Feb. 20, 2019

For more information: www.nae.edu

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Rhythm Management Device Hardware (Dual-chamber Pacemaker) coupled with BackBeat’s Cardiac Neuromodulation Therapy (CNT) bioelectronic therapy for Lowering Systolic Blood Pressure for patients with Pacemakers

Reporter: Aviva Lev-Ari, PhD, RN

 

BackBeat’s CNT is a bioelectronic therapy that immediately, substantially and chronically lowers blood pressure (BP) while simultaneously modulating the autonomic nervous system (ANS).  Mimicking the effects of multiple medications by reducing pre-load, after-load and sympathetic tone, it can be delivered using standard rhythm management device hardware such as dual-chamber pacemakers.

For more information: www.orchestrabiomed.com

October 2, 2018 — Two-year results of the Moderato I Study demonstrated immediate, substantial and sustained reduction in blood pressure when BackBeat cardiac neuromodulation therapy (CNT) was used in patients with persistent hypertension (office BP > 150mmHg). Patients in the study had persistent hypertension despite two or more anti-hypertensive medications and an indication for a pacemaker.

Results of the multicenter clinical trial were presented at the 2018 Transcatheter Cardiovascular Therapeutics (TCT) conference, Sept. 21-25 in San Diego, by Daniel Burkhoff, M.D., Ph.D., director, heart failure, hemodynamics and mechanical circulatory support research for the Cardiovascular Research Foundation (CRF).

“The clinical efficacy and safety data observed with BackBeat CNT in a patient population with a significant portion of isolated systolic disease is very promising. Hypertension affects over 70 percent of pacemaker patients. These patients could benefit substantially from a potent hypertension therapy such as BackBeat CNT that could be included in their already necessary pacemaker,” said Prof. Petr Neuzil, M.D., head of the Department of Cardiology of Na Homolce Hospital in Prague, Czech Republic and one of the principal investigators of the study.

The 27 patients that met the study inclusion criteria were implanted with BackBeat’s proprietary Moderato dual-chamber pacemaker that incorporates the BackBeat CNT algorithms. The primary safety and efficacy endpoint results of the study were as follows:

  • Efficacy Outcomes: Immediate, substantial and sustained reduction in blood pressure.
    • 14.2 mmHg decrease from baseline (p<0.001) in 24 hours ambulatory systolic blood pressure (AMB BP) at 3 months
    • 23.4 mmHg decrease from baseline (p < 0.001) in systolic blood pressure (SBP) sustained out to 2 years
  • High responder rate in a population where 78 percent of patients had isolated systolic hypertension.
    • 85 percent AMB BP reduced >5mmHg
    • 74 percent AMB BP reduced >10 mmHg
  • Safety Outcomes: The study met the safety endpoint.
    • Observed reduction in end systolic and diastolic volumes with no change to ejection fraction suggests improvement of cardiac function
    • Observed reduction in heart rate out to 2 years indicative of reduced sympathetic activity

“These statistically significant results demonstrate the potential for BackBeat CNT to be a broadly applicable therapy that substantially lowers blood pressure immediately and maintains reduced pressures for years,” commented Burkhoff. “It is rare to see a new therapy show such dramatic and sustained effects in such a small number of patients.”

To further investigate the efficacy and safety of BackBeat CNT for the treatment of hypertension, Orchestra BioMed is enrolling patients into a prospective, 1:1 randomized double-blind active treatment (BackBeat CNT) versus standard medical therapy trial, Moderato II. The study will enroll patients with uncontrolled blood pressure (office systolic > 140, day and AMB BP > 130 mmHg) treated with at least one anti-hypertension medication that are indicated for a dual-chamber pacemaker. The primary efficacy endpoint of the first cohort of the study is the comparison of the mean reduction in 24-hour systolic ambulatory blood pressure following 6 months of therapy between the treatment and the control. Primary safety endpoint is the rate of major adverse cardiac event (MACE) at 6 months between the treatment and control.  The company is expecting results on the first cohort of patients in 2019.

SOURCE

https://www.dicardiology.com/content/backbeat-cardiac-neuromodulation-therapy-reduces-blood-pressure-two-years?eid=333021707&bid=2258792

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