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Archive for the ‘Cardiac and Cardiovascular Surgical Procedures’ Category


Medical Device Representatives coach Surgeons in the Operating Rooms

Reporter: Aviva Lev-Ari, PhD, RN
Medical Device Representatives: The Untold Story

What Reps Don’t Do

As a surgeon and a healthcare executive, I’ve learned that the best device representatives are defined by what they won’t do: push a physician to use their product when it’s inappropriate. Villa says she sometimes sees patients who have blood clots in their arteries. “I will never recommend our product when there’s a clot because you can do more harm than good,” she says. “Ultimately, it’s up to the doctor’s discretion, but I’ll come right out and tell them, ‘I don’t know if CSI is the right product for that.’”

Just like physicians, device sales representatives have reputations to protect. A physician will recommend a helpful and knowledgeable sales representative to a colleague; but if the sales representative is clearly only interested in their bottom line — as opposed to the patient’s well-being — they’ll soon find that their calls go unanswered. For this reason, Nasser says he often finds himself advising physicians that his product isn’t appropriate for a patient. “You might not get the case,” he says, “but you’ll earn the trust of the physician.”

There’s a second — and more important — explanation for why these device representatives won’t push their products to boost sales. Simply put, that’s not why they’re in business. Nasser, for example, got into device sales after his father died of a heart attack. “I approach every case as if that were my family member and I ask what would be best for them,” he says.

“You can’t fake the passion and the caring you have,” adds Staub. “People see through if it’s just a business transaction.” Instead, he attributes his longevity to “engaging physicians in an educational way and getting across that you can be a partner in the care of their patients.”

When asked why she does her job, Villa thinks about the 77-year old woman she helped the day she drove to the hospital early in the morning. When the woman’s foot, which initially had turned grey, started to turn pink after the procedure, Villa says she was overcome with “a wonderful feeling. That patient had a fear of losing her limb and woke up knowing that her leg was still there. Saving limbs and saving lives. That’s the beauty of our job.”

¹ O’Connor B, Pollner F, Fugh-Berman A (2016) Salespeople in the Surgical Suite: Relationships between Surgeons and Medical Device Representatives. PLoS ONE 11(8): e0158510. https://doi.org/10.1371/journal.pone.0158510

² White, T. Stanford Medicine Magazine, 2006, Fall Issue. Father of invention – Stanford Medicine Magazine – Stanford University School of Medicine

³ Gawande, A. The New Yorker, October 3, 2011. The Coach in the Operating Room | The New Yorker

 

SOURCE

 

https://www.cardiovascularbusiness.com/sponsored/2052/medical-device-representatives-untold-story

From: Cardiovascular Business <announcements@mail.cardiovascularbusiness.com>

Reply-To: Cardiovascular Business <announcements@mail.cardiovascularbusiness.com>

Date: Monday, March 1, 2021 at 10:30 AM

To: “Aviva Lev-Ari, PhD, RN” <AvivaLev-Ari@alum.berkeley.edu>

Subject: The Untold Story of Medical Device Reps: A Physician’s Perspective

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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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Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement

Reporter: Aviva Lev-Ari, PhD, RN

Five-Year Outcomes of Transcatheter or Surgical Aortic-Valve Replacement

 

January 29, 2020
DOI: 10.1056/NEJMoa1910555

List of authors.

  • Raj R. Makkar, M.D.,
  • Vinod H. Thourani, M.D.,
  • Michael J. Mack, M.D.,
  • Susheel K. Kodali, M.D.,
  • Samir Kapadia, M.D.,
  • John G. Webb, M.D.,
  • Sung-Han Yoon, M.D.,
  • Alfredo Trento, M.D.,
  • Lars G. Svensson, M.D., Ph.D.,
  • Howard C. Herrmann, M.D.,
  • Wilson Y. Szeto, M.D.,
  • D. Craig Miller, M.D.,
  • et al.,

for the PARTNER 2 Investigators*

 

Abstract

BACKGROUND

There are scant data on long-term clinical outcomes and bioprosthetic-valve function after transcatheter aortic-valve replacement (TAVR) as compared with surgical aortic-valve replacement in patients with severe aortic stenosis and intermediate surgical risk.

METHODS

We enrolled 2032 intermediate-risk patients with severe, symptomatic aortic stenosis at 57 centers. Patients were stratified according to intended transfemoral or transthoracic access (76.3% and 23.7%, respectively) and were randomly assigned to undergo either TAVR or surgical replacement. Clinical, echocardiographic, and health-status outcomes were followed for 5 years. The primary end point was death from any cause or disabling stroke.

RESULTS

At 5 years, there was no significant difference in the incidence of death from any cause or disabling stroke between the TAVR group and the surgery group (47.9% and 43.4%, respectively; hazard ratio, 1.09; 95% confidence interval [CI], 0.95 to 1.25; P=0.21). Results were similar for the transfemoral-access cohort (44.5% and 42.0%, respectively; hazard ratio, 1.02; 95% CI, 0.87 to 1.20), but the incidence of death or disabling stroke was higher after TAVR than after surgery in the transthoracic-access cohort (59.3% vs. 48.3%; hazard ratio, 1.32; 95% CI, 1.02 to 1.71). At 5 years, more patients in the TAVR group than in the surgery group had at least mild paravalvular aortic regurgitation (33.3% vs. 6.3%). Repeat hospitalizations were more frequent after TAVR than after surgery (33.3% vs. 25.2%), as were aortic-valve reinterventions (3.2% vs. 0.8%). Improvement in health status at 5 years was similar for TAVR and surgery.

CONCLUSIONS

Among patients with aortic stenosis who were at intermediate surgical risk, there was no significant difference in the incidence of death or disabling stroke at 5 years after TAVR as compared with surgical aortic-valve replacement. (Funded by Edwards Lifesciences; PARTNER 2 ClinicalTrials.gov number, NCT01314313. opens in new tab.)

 

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Comparison between balloon-expandable (Sapien XT or Sapien 3 valve, Edwards Lifesciences) vs self-expanding (CoreValve, Medtronic) TAVR from 2013 to 2015, Results: Lower mortality rate and other advantages with balloon-expandable valves over self-expanding valves.

Reporter: Aviva Lev-Ari, PhD, RN

 

French Studies Point to Inherent Differences in TAVR Valves

FRANCE-TAVI database was funded and managed by the French Society of Cardiology and French Working Group of Interventional Cardiology. Edwards Lifesciences and Medtronic partly funded the registry, but had no role in data collection, analysis, or manuscript drafting. Van Belle, Dehara, Abdel-Wahab, and Thiele report no relevant conflicts of interest.

Circulation. Published online November 16, 2019. AbstractAbstractEditorial

American Heart Association (AHA) Scientific Sessions 2019; presented November 16, 2019.

Follow Patrice Wendling on Twitter: @pwendl. For more from theheart.org | Medscape Cardiology, join us on Twitter and Facebook.

Patrice Wendling

November 25, 2019

The coprimary end point of at least moderate paravalvular regurgitation (PVR) at discharge and/or in-hospital mortality was more common with a self-expanding (SE) valve than with a balloon-expandable (BE) valve (19.8% vs 11.9%; relative risk [RR], 1.68). This related to nearly twofold more PVR (15.5% vs 8.3%; RR, 1.90) and a 1.4% absolute mortality difference (5.6% vs 4.2%; RR, 1.33).

Need for a permanent pacemaker (22.3% vs 11.0%; P < .0001) and a second transcatheter heart valve (3.7% vs 1.0%; P < .0001) was more frequent with SE valves.

Patients receiving an SE valve also had higher rates of myocardial infarction (0.4% vs 0.2%; P = .02) but had a lower mean transprosthetic gradient than those receiving a BE valve (7 vs 10; P < .0001).

At 2 years, use of a self-expanding valve was associated with a higher risk for all-cause mortality (29.8% vs 26.6%; hazard ratio, 1.17; 95% CI, 1.06 – 1.28) and cardiovascular death (23.3% vs 20.9%; P = .001). This is explained by a 36% excess risk for death during the first 3 months (= .0001), with the two mortality curves remaining parallel thereafter, Van Belle said.

The findings were consistent across subgroups, although the difference in the primary composite end point was stronger for those who received transfemoral TAVR and for those treated at the end of the study in 2015.

On multivariable analysis, independent predictors of all-cause mortality were valve design and PVR severity, according to the study, simultaneously published online in Circulation.

Limitations include the use of observational data, potential unmeasured residual confounders, site-reported PVR grading and clinical events (except mortality), and a lack of newer valve designs, Van Belle said.

“The present study strongly supports conducting a randomized trial in order to compare head-to-head the most recent iterations of SE and BE THVs on all-cause mortality,” he concluded.

The study, he said, “points out, if nothing else, that perhaps there is an inherent difference between the TAVR valves. It may be incorrect to assume it is a class effect.”

A second propensity-matched analysis, also published online in Circulation but not presented at AHA, used the nationwide French administrative hospital-discharge database to compare 10,459 matched pairs who underwent TAVR with the balloon-expandable Sapien 3 or self-expanding Evolut R (Medtronic) valve from 2014 to 2018.

Over a mean follow-up of 358 days, use of the BE vs the SE valve was associated with a lower yearly incidence of all-cause death (rate ratio, 0.88; corrected P = .005), cardiovascular death (rate ratio, 0.82; corrected P = .002), and rehospitalization for heart failure (rate ratio, 0.84; corrected P < .0001).

Pacemaker implantation was also lower with the balloon-expandable valve (rate ratio, 0.72; corrected < .0001), Pierre Deharo, MD, PhD, CHU Timone, Marseille, France, and colleagues report.

In an editorial accompanying the two analyses, Mohamed Abdel-Wahab, MD, and Holger Thiele, MD, both with the Heart Center Leipzig at the University of Leipzig, Germany, praised the authors for reporting what is currently the largest published dataset comparing the two valve designs. The limitations of registry-based analyses, however, are “obvious, and the findings should therefore be considered thought-provoking but by no means definite.”

SOURCE

https://www.medscape.com/viewarticle/921791?nlid=132763_3866&src=WNL_mdplsfeat_191126_mscpedit_card&uac=93761AJ&spon=2&impID=2182575&faf=1

Other related articles published in this Open Access Online Scientific Journal include the following 73 articles:

https://pharmaceuticalintelligence.com/?s=TAVR

 

 

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Risks from Dual Antiplatelet Therapy (DAPT) may be reduced by Genotyping Guidance of Cardiac Patients

Reporter: Aviva Lev-Ari, PhD, RN

 

Genotyping Cardiac Patients May Reduce Risks From DAPT

-STEMI patient study reaches noninferiority mark for adverse cardiac events

In the investigational arm, all 1,242 patients were tested for CYP2C19 loss-of-function alleles *2 or *3. Carriers received ticagrelor or prasugrel, while noncarriers received clopidogrel, considered to be less powerful.

No genetic testing was performed in the standard treatment arm (n=1,246), in which patients largely went on to receive ticagrelor or prasugrel. Nearly all patients in both cohorts received dual antiplatelet therapy (DAPT) with aspirin.

Following primary PCI, patients went on to the P2Y12 inhibitor for at least 12 months, with drug adherence similar between the genotype-guided (84.5%) and standard groups (82.0%).

For patients with CYP2C19 loss-of-function alleles in the genotype-guided arm, 38% received ticagrelor and 1% received prasugrel. The remaining 61% of patients — the noncarriers — received clopidogrel. In the control arm, 91% were treated with ticagrelor, 2% with prasugrel, and 7% with clopidogrel, according to local protocol.

Ten Berg said that prasugrel is not typically used in the Netherlands, where eight of the centers in the trial were located, but that this might change given that the drug lowered rates of ischemic events versus ticagrelor in the head-to-head ISAR REACT 5 trial, which was also presented at ESC.

Reviewed by Robert Jasmer, MD Associate Clinical Professor of Medicine, University of California, San Francisco

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Post TAVR: Management of conduction disturbances and number of valve recapture and/or repositioning attempts – Optimize self-expanding transcatheter aortic valve replacement (TAVR) positioning reduced the need for permanent pacemaker (PPM) implants down the road

Reporter: Aviva Lev-Ari, PhD, RN

UPDATED on 4/14/2021

Specialists complete first procedure in historic head-to-head TAVR study

A study with significant implications for the future of patient care is officially underway. Specialists at Penn Medicine in Philadelphia have reported completing the first procedure in a global head-to-head study comparing the safety and effectiveness of two leading transcatheter aortic valve replacement (TAVR) systems.

The Small Annuli Randomized to Evolut or Sapien (SMART) post-market trial is designed to compare the safety and effectiveness of self-expanding TAVR systems manufactured by Medtronic and balloon-expandable systems manufactured by Edwards Lifesciences when treating patients with small annuli. More than 90 different facilities are taking part in the trial, and approximately 700 patients with severe symptomatic aortic stenosis are expected to participate. A majority of study participants are expected to be women due to the trial’s focus on individuals with small annuli.

Howard C. Herrmann, MD, a professor of cardiovascular diseases at the University of Pennsylvania’s Perelman School of Medicine, is leading the trial.

“Penn Medicine has been in on the ground floor of many of the early and landmark trials in TAVR research since performing one of the first investigational procedures in 2007, and, since then, we have completed thousands of these procedures,” he said in a prepared statement. “Subsequently, multiple devices have been FDA approved, and the procedure has grown to become the predominant one for all patients with aortic stenosis. The outcome of this study will help cardiac teams to make more tailored decisions about which kind of valve to use on which patients.”

The SMART trial’s estimated primary completion date is May 2023. The estimated study completion date, meanwhile, is May 2028.

  • The PPM rate dropped from 9.7% to 3.0% (P=0.035), according to a team led by Hasan Jilaihawi, MD, of NYU Langone Health in New York City.
  • the PARTNER 3 and CoreValve Low Risk trials in patients at low surgical risk showed PPM implant rates of 17.4% with the Evolut line, 6.6% with the balloon-expandable Sapien 3, and 4.1%-6.1% with surgery.
  • “The His bundle passes through the membranous septum, a few millimeters beneath the non-coronary/right coronary cusps. It is therefore not surprising that a deeper valve implantation increases the likelihood of mechanical damage of the His bundle leading to a transient or persistent conduction disturbance,” according to Rodés-Cabau.

To capture factors that contributed to need for PPM implantation, Jilaihawi and colleagues performed a detailed restrospective analysis on 248 consecutive Evolut recipients at Langone treated with the standard TAVR approach — aiming for 3-4 mm implant depth (in relation to the non-coronary cusp) and recapturing and repositioning when the device landed considerably lower. Patients with prior PPM implantation were excluded. Devices used were Medtronic’s Evolut R, Evolut Pro, and Evolut 34XL.

This analysis revealed that use of the large Evolut 34XL (OR 4.96, 95% CI 1.68-14.63) and implant depth exceeding membranous septum length (OR 8.04, 95% CI 2.58-25.04) were independent predictors of later PPM implantation.

From there, operators came up with the MIDAS technique and applied it prospectively to another 100 consecutive patients.

Besides bringing down the PPM implant rate to 3.0%, there were no more cases of valve embolization, dislocation, or need for a second valve.

The standard and MIDAS groups shared similar membranous septum lengths but diverged in average actual device depth, such that the standard group tended to have Evolut devices positioned deeper (3.3 mm vs 2.3 mm, P<0.001).

SOURCE

https://www.medpagetoday.com/cardiology/pci/81849

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Digital Therapeutics: A Threat or Opportunity to Pharmaceuticals


Digital Therapeutics: A Threat or Opportunity to Pharmaceuticals

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

 

Digital Therapeutics (DTx) have been defined by the Digital Therapeutics Alliance (DTA) as “delivering evidence based therapeutic interventions to patients, that are driven by software to prevent, manage or treat a medical disorder or disease”. They might come in the form of a smart phone or computer tablet app, or some form of a cloud-based service connected to a wearable device. DTx tend to fall into three groups. Firstly, developers and mental health researchers have built digital solutions which typically provide a form of software delivered Cognitive-Behaviour Therapies (CBT) that help patients change behaviours and develop coping strategies around their condition. Secondly there are the group of Digital Therapeutics which target lifestyle issues, such as diet, exercise and stress, that are associated with chronic conditions, and work by offering personalized support for goal setting and target achievement. Lastly, DTx can be designed to work in combination with existing medication or treatments, helping patients manage their therapies and focus on ensuring the therapy delivers the best outcomes possible.

 

Pharmaceutical companies are clearly trying to understand what DTx will mean for them. They want to analyze whether it will be a threat or opportunity to their business. For a long time, they have been providing additional support services to patients who take relatively expensive drugs for chronic conditions. A nurse-led service might provide visits and telephone support to diabetics for example who self-inject insulin therapies. But DTx will help broaden the scope of support services because they can be delivered cost-effectively, and importantly have the ability to capture real-world evidence on patient outcomes. They will no-longer be reserved for the most expensive drugs or therapies but could apply to a whole range of common treatments to boost their efficacy. Faced with the arrival of Digital Therapeutics either replacing drugs, or playing an important role alongside therapies, pharmaceutical firms have three options. They can either ignore DTx and focus on developing drug therapies as they have done; they can partner with a growing number of DTx companies to develop software and services complimenting their drugs; or they can start to build their own Digital Therapeutics to work with their products.

 

Digital Therapeutics will have knock-on effects in health industries, which may be as great as the introduction of therapeutic apps and services themselves. Together with connected health monitoring devices, DTx will offer a near constant stream of data about an individuals’ behavior, real world context around factors affecting their treatment in their everyday lives and emotional and physiological data such as blood pressure and blood sugar levels. Analysis of the resulting data will help create support services tailored to each patient. But who stores and analyses this data is an important question. Strong data governance will be paramount to maintaining trust, and the highly regulated pharmaceutical industry may not be best-placed to handle individual patient data. Meanwhile, the health sector (payers and healthcare providers) is becoming more focused on patient outcomes, and payment for value not volume. The future will say whether pharmaceutical firms enhance the effectiveness of drugs with DTx, or in some cases replace drugs with DTx.

 

Digital Therapeutics have the potential to change what the pharmaceutical industry sells: rather than a drug it will sell a package of drugs and digital services. But they will also alter who the industry sells to. Pharmaceutical firms have traditionally marketed drugs to doctors, pharmacists and other health professionals, based on the efficacy of a specific product. Soon it could be paid on the outcome of a bundle of digital therapies, medicines and services with a closer connection to both providers and patients. Apart from a notable few, most pharmaceutical firms have taken a cautious approach towards Digital Therapeutics. Now, it is to be observed that how the pharmaceutical companies use DTx to their benefit as well as for the benefit of the general population.

 

References:

 

https://eloqua.eyeforpharma.com/LP=23674?utm_campaign=EFP%2007MAR19%20EFP%20Database&utm_medium=email&utm_source=Eloqua&elqTrackId=73e21ae550de49ccabbf65fce72faea0&elq=818d76a54d894491b031fa8d1cc8d05c&elqaid=43259&elqat=1&elqCampaignId=24564

 

https://www.s3connectedhealth.com/resources/white-papers/digital-therapeutics-pharmas-threat-or-opportunity/

 

http://www.pharmatimes.com/web_exclusives/digital_therapeutics_will_transform_pharma_and_healthcare_industries_in_2019._heres_how._1273671

 

https://www.mckinsey.com/industries/pharmaceuticals-and-medical-products/our-insights/exploring-the-potential-of-digital-therapeutics

 

https://player.fm/series/digital-health-today-2404448/s9-081-scaling-digital-therapeutics-the-opportunities-and-challenges

 

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Immunoediting can be a constant defense in the cancer landscape


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

 

There are many considerations in the cancer immunoediting landscape of defense and regulation in the cancer hallmark biology. The cancer hallmark biology in concert with key controls of the HLA compatibility affinity mechanisms are pivotal in architecting a unique patient-centric therapeutic application. Selection of random immune products including neoantigens, antigens, antibodies and other vital immune elements creates a high level of uncertainty and risk of undesirable immune reactions. Immunoediting is a constant process. The human innate and adaptive forces can either trigger favorable or unfavorable immunoediting features. Cancer is a multi-disease entity. There are multi-factorial initiators in a certain disease process. Namely, environmental exposures, viral and / or microbiome exposure disequilibrium, direct harm to DNA, poor immune adaptability, inherent risk and an individual’s own vibration rhythm in life.

 

When a human single cell is crippled (Deranged DNA) with mixed up molecular behavior that is the initiator of the problem. A once normal cell now transitioned into full threatening molecular time bomb. In the modeling and creation of a tumor it all begins with the singular molecular crisis and crippling of a normal human cell. At this point it is either chop suey (mixed bit responses) or a productive defensive and regulation response and posture of the immune system. Mixed bits of normal DNA, cancer-laden DNA, circulating tumor DNA, circulating normal cells, circulating tumor cells, circulating immune defense cells, circulating immune inflammatory cells forming a moiety of normal and a moiety of mess. The challenge is to scavenge the mess and amplify the normal.

 

Immunoediting is a primary push-button feature that is definitely required to be hit when it comes to initiating immune defenses against cancer and an adaptation in favor of regression. As mentioned before that the tumor microenvironment is a “mixed bit” moiety, which includes elements of the immune system that can defend against circulating cancer cells and tumor growth. Personalized (Precision-Based) cancer vaccines must become the primary form of treatment in this case. Current treatment regimens in conventional therapy destroy immune defenses and regulation and create more serious complications observed in tumor progression, metastasis and survival. Commonly resistance to chemotherapeutic agents is observed. These personalized treatments will be developed in concert with cancer hallmark analytics and immunocentrics affinity and selection mapping. This mapping will demonstrate molecular pathway interface and HLA compatibility and adaptation with patientcentricity.

References:

 

https://www.linkedin.com/pulse/immunoediting-cancer-landscape-john-catanzaro/

 

https://www.cell.com/cell/fulltext/S0092-8674(16)31609-9

 

https://www.researchgate.net/publication/309432057_Circulating_tumor_cell_clusters_What_we_know_and_what_we_expect_Review

 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4190561/

 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5840207/

 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5593672/

 

https://www.frontiersin.org/articles/10.3389/fimmu.2018.00414/full

 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5593672/

 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4190561/

 

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4388310/

 

https://www.linkedin.com/pulse/cancer-hallmark-analytics-omics-data-pathway-studio-review-catanzaro/

 

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Mitralign and Corvia, Tewksbury, Mass – Investment and Acquisition by Edwards Lifesciences

 

Reporter: Aviva Lev-Ari, PhD, RN

 

Edwards LifesciencesEdwards Lifesciences (NYSE:EW) said today that it made a pair of strategic bets on the structural heart space, paying $35 million for the right to acquire Corvia Medical and paying an unspecified amount for some of mitral valve repair device maker Mitralign‘s assets.

Tewksbury, Mass.-based Corvia is developing an interatrial shunt to treat heart failure by creating a small opening between the left and right atria to lower blood pressure in the left atrium and lungs. The device has CE Mark approval in the European Union and a pivotal U.S trial aimed at winning a nod from the FDA is under way, Edwards said.

“We are extremely pleased to have the support of the global leader in patient-focused innovations for structural heart disease as we continue to advance this novel treatment for heart failure,” Corvia president & CEO George Fazio said in prepared remarks. “We are proud of our accomplishments to date and look forward to completing the pivotal study with the support of our global clinical investigators.”

The Irvine, Calif.-based company also said it bought “certain” Mitralign assets, including intellectual property and associated clinical and regulatory experience. Mitralign, also based in Tewksbury, is developing an annuloplasty system for treating functional mitral and tricuspid regurgitation.

Edwards said the transactions are not expected to affect its financial outlook for 2019.

SOURCE

https://www.massdevice.com/edwards-lifesciences-gets-in-on-corvia-mitralign/?spMailingID=1958&puid=370787

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