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Archive for the ‘FDA, CE Mark & Global Regulatory Affairs: process management and strategic planning – GCP, GLP, ISO 14155’ Category


A Timeline of Dr. Gottlieb’s Tenure at the FDA: 2017-2019

Reporter: Stephen J. Williams, Ph.D.

 

From FiercePharma.com

FDA chief Scott Gottlieb steps down, leaving pet projects behind

Scott Gottlieb FDA
FDA Commissioner Scott Gottlieb was appointed by President Trump in 2017. (FDA)

Also under his command, the FDA took quick and decisive action on drug costs. The commissioner worked to boost generic approvals and crack down on regulatory “gaming” that stifles competition. He additionally blamed branded drug companies for an “anemic” U.S. biosimilars market and recently blasted insulin pricing.

His sudden departure will likely leave many agency efforts to lower costs up in the air. After the news broke, many pharma watchers posted on Twitter that Gottlieb’s resignation is a loss for the industry.

During his tenure as FDA commissioner, Gottlieb’s name had been floated for HHS chief when former HHS secretary Tom Price resigned due to a travel scandal, but Gottlieb said he was best suited for the FDA commissioner job. Now, former Eli Lilly executive Alex Azar serves as HHS secretary, and on Tuesday afternoon, Azar praised Gottlieb for his work at the agency.

Also read from FiercePharma:

Gottlieb’s quick goodbye triggers investor panic, biopharma bewilderment and at least one good riddance

AUDIT Podcast

An emergency Scott Gottlieb podcast

 

Why is Scott Gottlieb quitting the FDA? Who will replace him?

 

A Timeline of Dr. Gottlieb’s Tenure at the FDA

From FiercePharma.com

New FDA commissioner Gottlieb unveils price-fighting strategies

Scott Gottlieb
New FDA commissioner Scott Gottlieb laid out some approaches the agency will take to fight high prices.

Other posts on the Food and Drug Administration and FDA Approvals during Dr. Gotlieb’s Tenure on this Open Access Journal Include:

 

Regulatory Affairs: Publications on FDA-related Issues – Aviva Lev-Ari, PhD, RN

FDA Approves La Jolla’s Angiotensin 2

In 2018, FDA approved an all-time record of 62 new therapeutic drugs (NTDs) [Not including diagnostic imaging agents, included are combination products with at least one new molecular entity as an active ingredient] with average Peak Sales per NTD $1.2Billion.

Alnylam Announces First-Ever FDA Approval of an RNAi Therapeutic, ONPATTRO™ (patisiran) for the Treatment of the Polyneuropathy of Hereditary Transthyretin-Mediated Amyloidosis in Adults

FDA: Rejects NDA filing: “clinical and non-clinical pharmacology sections of the application were not sufficient to complete a review”: Celgene’s Relapsing Multiple Sclerosis Drug – Ozanimod

Expanded Stroke Thrombectomy Guidelines: FDA expands treatment window for use (Up to 24 Hours Post-Stroke) of clot retrieval devices (Stryker’s Trevo Stent) in certain stroke patients

In 2017, FDA approved a record number of 19 personalized medicines — 16 new molecular entities and 3 gene therapies – PMC’s annual analysis, titled Personalized Medicine at FDA: 2017 Progress Report

FDA Approval marks first presentation of bivalirudin in frozen, premixed, ready-to-use formulation

Skin Regeneration Therapy One of First Tissue Engineering Products Evaluated by FDA

FDA approval on 12/1/2017 of Amgen’s evolocumb (Repatha) a PCSK9 inhibitor for the prevention of heart attacks, strokes, and coronary revascularizations in patients with established cardiovascular disease

FDA Approval of Anti-Depression Digital Pill Tracks Use When Swallowed and transmits to MDs Smartphone – A Breakthrough in Medication Remote Compliance Monitoring

Medical Devices Early Feasibility FDA’s Pathway – Accelerated Recruitment for Randomized Clinical Trials: Replacement and Repair of Mitral Valves

Novartis’ Kymriah (tisagenlecleucel), FDA approved genetically engineered immune cells, would charge $475,000 per patient, will use Programs that Payers will pay only for Responding Patients 

FDA has approved the world’s first CAR-T therapy, Novartis for Kymriah (tisagenlecleucel) and Gilead’s $12 billion buy of Kite Pharma, no approved drug and Canakinumab for Lung Cancer (may be?)

FDA: CAR-T therapy outweigh its risks tisagenlecleucel, manufactured by Novartis of Basel – 52 out of 63 participants — 82.5% — experienced overall remissions – young patients with Leukaemia [ALL]

‘Landmark FDA approval bolsters personalized medicine’ by Edward Abrahams, PhD, President, PMC

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In 2018, FDA approved an all-time record of 62 new therapeutic drugs (NTDs) [Not including diagnostic imaging agents, included are combination products with at least one new molecular entity as an active ingredient] with average Peak Sales per NTD $1.2Billion.

 

Reporter: Aviva Lev-Ari, PhD, RN

BIOBUSINESS BRIEFS

2018 FDA approvals hit all-time high — but average value slips again

In 2018, the FDA approved an all-time record of 62 new therapeutic drugs (NTDs; see Fig. 1 for the definition and the difference compared with new molecular entities). This is consistent with the increase we predicted last year (Nat. Rev. Drug Discov. 17, 87; 2018) and the overall resurgence of R&D in the last 5 years, with an average of 51 approvals per year in this period even with a low count in 2016. This is substantially more than the average of 31 approvals per year in the period 2000–2013 (Fig. 1).

Fig. 1 | FDA approvals of new therapeutic drugs and aggregate projected peak global annual sales: 2000–2018. We analysed 2018 FDA approvals of new therapeutic drugs (NTDs), defined as new molecular entities approved by the FDA’s Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), but with two adjustments: first, we excluded diagnostic imaging agents; and second, we included combination products with at least one new molecular entity as an active ingredient. The analysis is based exclusively on approvals by the FDA and the year in which the first indication approval took place. All peak sales values were obtained from EvaluatePharma and were inflation-adjusted to 2018 using standard global GDP-based inflators sourced from the Economist Intelligence Unit. To arrive at peak sales for each NTD, we reviewed both historical actual sales as well as the full range of forecast sales that are available from EvaluatePharma and selected the highest value. Sources: EvaluatePharma, FDA and Boston Consulting Group analysis.

SOURCE

https://www.nature.com/articles/d41573-019-00004-z

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Innovators in Therapeutics: John Maraganore, the CEO of Alnylam, and Sara Nochur, Alnylam’s Senior VP Regulatory Affairs, November 15, 2018, 4:30 PM – 6:30 PM, HMS

Reporter: Aviva Lev-Ari, PhD, RN

 

 

Innovators in Therapeutics, a Student Speaker Series

by Harvard-MIT Center for Regulatory Science

Free

Actions and Detail Panel

Innovators in Therapeutics, a Student Speaker Series

Thu, November 15, 2018, 4:30 PM – 6:30 PM EST

LOCATION

Cannon Room, Building C, Harvard Medical School

240 Longwood Ave

Boston, MA 02115

View Map

 

Free

 

REGISTER

Event Information

DESCRIPTION

Please join us for the Innovators in Therapeutics student speaker series organized by the Harvard-MIT Center for Regulatory Science and the Harvard Program in Therapeutic Science. The first installment of this series will feature John Maraganore, the CEO of Alnylam, and Sara Nochur, Alnylam’s Senior Vice President for Regulatory Affairs. Dr. Maraganore and Dr. Nochur will describe Alnylam’s path through development and FDA approval of the first RNAi therapeutic, ONPATTRO™ (patisiran), for the treatment of polyneuropathy of hereditary transthyretin-mediated amyloidosis. Dr. Maraganore and Dr. Nochur will focus on the regulatory science aspects of gaining approval for this innovative therapeutic.

Prior to the seminar, please join us for a networking session that brings together faculty, students and trainees who are interested in translational research, pharmacology, biotechnology, and regulatory science. Following the speaking program, there will be a small group discussion for students and trainees to engage directly with the expert about the topic at hand. Participation in the small group discussion is limited to students who register and are confirmed prior to the event.

This event is free and open to the Boston research community. Please help us to plan by RSVPing here!

 

AGENDA

4:30 – 5:00pm: Pre-event reception (outside Cannon Room)

5:00 – 5:45pm: Innovators in Therapeutics with Alnylam’s John Maraganore & Sara Nochur (Cannon Room)

5:45 – 6:15pm: [Limited Space] Student and Trainee Q&A with John Maraganore & Sara Nochur (Folin Wu Room)

SOURCE

https://www.eventbrite.com/e/innovators-in-therapeutics-a-student-speaker-series-tickets-50806305026

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21st Century Cures Act reforms to the Food and Drug Administration’s (FDA) regulation of the medical device and pharmaceutical industries – Medical Device Overview: Major FDA Reform Bill Becomes Law

Reporter: Aviva Lev-Ari, PhD, RN

 

HIGHLIGHTS

  • The 21st Century Cures Act seeks to expedite development of, and provide priority review for, “breakthrough” devices
  • The act requires FDA to provide training on the meaning and implementation of the least burdensome review standard, and requires an audit of the results
  • The act expressly excludes certain categories of medical software from FDA regulation

Major provisions of the act related to medical device regulation found in Subtitle F are listed, below.

 

President Obama recently signed the 996-page 21st Century Cures Act to implement a variety of reforms to the Food and Drug Administration’s (FDA) regulation of the medical device and pharmaceutical industries.

This alert summarizes the major provisions of the act related to medical device regulation found in Subtitle F.

Read more: http://www.btlaw.com/Food-Drug-and-Device-Law-Alert—Major-FDA-Reform-Bill-Becomes-Law-Medical-Device-Overview-12-13-2016/

 

Section 3051 – Breakthrough Devices

Section 3052 – Humanitarian Device Exemption (HDE)

Section 3053 – Recognition of Standards

Section 3054 – Certain Class 1 and Class II Devices

Section 3055 – Classification Panels

Section 3056 – Institutional Review Board Flexibility

Section 3057 – CLIA Waiver Improvements

Section 3058 – Least Burdensome Device Review

Section 3059 – Cleaning Instructions and Validation Data Requirement

Section 3060 – Clarifying Medical Software Regulation

 

A copy of the act can be found here.

http://docs.house.gov/billsthisweek/20161128/CPRT-114-HPRT-RU00-SAHR34.pdf

 

For more information, please contact the Barnes & Thornburg LLP attorney with whom you work or one of the following attorneys in the firm’s Food, Drug & Device Group: Lynn Tyler at (317) 231-7392 or lynn.tyler@btlaw.com; Beth Davis at (404) 264-4025 or beth.davis@btlaw.com; or Alicia Raines Barr at (317) 231-7398 or alicia.rainesbarr@btlaw.com.

Visit us online at www.btlaw.com/food-drug-and-device-law-practices.

 

SOURCE

http://www.btlaw.com/files/Uploads/Documents/2016%20Alerts/Food,%20Drug%20and%20Device/FDA%20Alert%20-%2021st%20Century%20Cures%20Act.pdf

http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM393978.pdf

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

Medical Devices

https://pharmaceuticalintelligence.com/category/medical-devices-rd-investment/

FDA

https://pharmaceuticalintelligence.com/category/fda-regulatory-affairs/

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Entire Family of Impella Abiomed Impella® Therapy Left Side Heart Pumps: FDA Approved To Enable Heart Recovery

Reporter: Aviva Lev-Ari, PhD, RN

 

Abiomed Impella® Therapy Receives FDA Approval for Cardiogenic Shock After Heart Attack or Heart Surgery

Entire Family of Impella Left Side Heart Pumps FDA Approved To Enable Heart Recovery

DANVERS, Mass., April 07, 2016 (GLOBE NEWSWIRE) — Abiomed, Inc. (NASDAQ:ABMD), a leading provider of breakthrough heart support technologies, today announced that it has received U.S. Food and Drug Administration (FDA) Pre-Market Approval (PMA) for its Impella 2.5™, Impella CP®, Impella 5.0™ and Impella LD™ heart pumps to provide treatment of ongoing cardiogenic shock. In this setting, the Impella heart pumps stabilize the patient’s hemodynamics, unload the left ventricle, perfuse the end organs and allow for recovery of the native heart.  This latest approval adds to the prior FDA indication of Impella 2.5 for high risk percutaneous coronary intervention (PCI), or Protected PCI™, received in March 2015.

With this approval, these are the first and only percutaneous temporary ventricular support devices that are FDA-approved as safe and effective for the cardiogenic shock indication, as stated below:

The Impella 2.5, Impella CP, Impella 5.0 and Impella LD catheters, in conjunction with the Automated Impella Controller console, are intended for short-term use (<4 days for the Impella 2.5 and Impella CP and <6 days for the Impella 5.0 and Impella LD) and indicated for the treatment of ongoing cardiogenic shock that occurs immediately (<48 hours) following acute myocardial infarction (AMI) or open heart surgery as a result of isolated left ventricular failure that is not responsive to optimal medical management and conventional treatment measures with or without an intra-aortic balloon pump.  The intent of the Impella system therapy is to reduce ventricular work and to provide the circulatory support necessary to allow heart recovery and early assessment of residual myocardial function.

The product labeling also allows for the clinical decision to leave Impella 2.5, Impella CP, Impella 5.0 and Impella LD in place beyond the intended duration of four to six days due to unforeseen circumstances.

The Impella products offer the unique ability to both stabilize the patient’s hemodynamics before or during a PCI procedure and unload the heart, which allows the muscle to rest and potentially recover its native function. Heart recovery is the ideal option for a patient’s quality of life and as documented in several clinical papers, has the ability to save costs for the healthcare system1,2,3.

Cardiogenic shock is a life-threatening condition in which the heart is suddenly unable to pump enough blood and oxygen to support the body’s vital organs. For this approval, it typically occurs during or after a heart attack or acute myocardial infarction (AMI) or cardiopulmonary bypass surgery as a result of a weakened or damaged heart muscle. Despite advancements in medical technology, critical care guidelines and interventional techniques, AMI cardiogenic shock and post-cardiotomy cardiogenic shock (PCCS) carry a high mortality risk and has shown an incremental but consistent increase in occurrence in recent years in the United States.

“This approval sets a new standard for the entire cardiovascular community as clinicians continue to seek education and new approaches to effectively treat severely ill cardiac patients with limited options and high mortality risk,” said William O’Neill, M.D., medical director of the Center for Structural Heart Disease at Henry Ford Hospital. “The Impella heart pumps offer the ability to provide percutaneous hemodynamic stability to high-risk patients in need of rapid and effective treatment by unloading the heart, perfusing the end organs and ultimately, allowing for the opportunity to recover native heart function.”

“Abiomed would like to recognize our customers, physicians, nurses, scientists, regulators and employees for their last fifteen years of circulatory support research and clinical applications. This FDA approval marks a significant milestone in the treatment of heart disease. The new medical field of heart muscle recovery has begun,” said Michael R. Minogue, President, Chairman and Chief Executive Officer of Abiomed. “Today, Abiomed only treats around 5% of this AMI cardiogenic shock patient population, which suffers one of the highest mortality risks of any patient in the heart hospital. Tomorrow, Abiomed will be able to educate and directly partner with our customers and establish appropriate protocols to improve the patient outcomes focused on native heart recovery.”

Abiomed Data Supporting FDA Approval

The data submitted to the FDA in support of the PMA included an analysis of 415 patients from the RECOVER 1 study and the U.S. Impella registry (cVAD Registry™), as well as an Impella literature review including 692 patients treated with Impella from 17 clinical studies. A safety analysis reviewed over 24,000 Impella treated patients using the FDA medical device reporting (“MDR”) database, which draws from seven years of U.S. experience with Impella.

In addition, the Company also provided a benchmark analysis of Impella patients in the real-world Impella cVAD registry vs. these same patient groups in the Abiomed AB5000/BVS 5000 Registry. The Abiomed BVS 5000 product was the first ventricular assist device (VAD) ever approved by the FDA in 1991 based on 83 patient PMA study. In 2003, the AB5000 Ventricle received FDA approval and this also included a PMA study with 60 patients.

For this approval, the data source for this benchmark analysis was a registry (“AB/BVS Registry”) that contained 2,152 patients that received the AB5000 and BVS 5000 devices, which were originally approved for heart recovery. The analysis examined by the FDA used 204 patients that received the AB5000 device for the same indications. This analysis demonstrated significantly better outcomes with Impella in these patients.

The Company believes this is the most comprehensive review ever submitted to the FDA for circulatory support in the cardiogenic shock population.

  1. Maini B, Gregory D, Scotti DJ, Buyantseva L. Percutaneous cardiac assist devices compared with surgical hemodynamic support alternatives: Cost-Effectiveness in the Emergent Setting.Catheter Cardiovasc Interv. 2014 May 1;83(6):E183-92.
  2. Cheung A, Danter M, Gregory D. TCT-385 Comparative Economic Outcomes in Cardiogenic Shock Patients Managed with the Minimally Invasive Impella or Extracorporeal Life Support. J Am Coll Cardiol. 2012;60(17_S):. doi:10.1016/j.jacc.2012.08.413.
  3. Gregory D, Scotti DJ, de Lissovoy G, Palacios I, Dixon, Maini B, O’Neill W. A value-based analysis of hemodynamic support strategies for high-risk heart failure patients undergoing a percutaneous coronary intervention. Am Health Drug Benefits. 2013 Mar;6(2):88-99


ABOUT IMPELLA

Impella 2.5 received FDA PMA approval for high risk PCI in March 2015, is supported by clinical guidelines, and is reimbursed by the Centers for Medicare & Medicaid Services (CMS) under ICD-9-CM code 37.68 for multiple indications. The Impella RP® device received Humanitarian Device Exemption (HDE) approval in January 2015. The Impella product portfolio, which is comprised of Impella 2.5, Impella CP, Impella 5.0, Impella LD, and Impella RP, has supported over 35,000 patients in the United States.

The ABIOMED logo, ABIOMED, Impella, Impella CP, and Impella RP are registered trademarks of Abiomed, Inc. in the U.S.A. and certain foreign countries.  Impella 2.5, Impella 5.0, Impella LD, and Protected PCI are trademarks of Abiomed, Inc.

ABOUT ABIOMED
Based in Danvers, Massachusetts, Abiomed, Inc. is a leading provider of medical devices that provide circulatory support.  Our products are designed to enable the heart to rest by improving blood flow and/or performing the pumping of the heart.  For additional information, please visit: www.abiomed.com

FORWARD-LOOKING STATEMENTS
This release includes forward-looking statements.  These forward-looking statements generally can be identified by the use of words such as “anticipate,” “expect,” “plan,” “could,” “may,” “will,” “believe,” “estimate,” “forecast,” “goal,” “project,” and other words of similar meaning.  These forward-looking statements address various matters including, the Company’s guidance for fiscal 2016 revenue. Each forward-looking statement contained in this press release is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statement.  Applicable risks and uncertainties include, among others, uncertainties associated with development, testing and related regulatory approvals, including the potential for future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, litigation matters, future capital needs and uncertainty of additional financing, and the risks identified under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended March 31, 2015 and the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2015, each filed with the Securities and Exchange Commission, as well as other information the Company files with the SEC.  We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.  You are encouraged to read our filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties.  The forward-looking statements in this press release speak only as of the date of this release and the Company undertakes no obligation to update or revise any of these statements.  Our business is subject to substantial risks and uncertainties, including those referenced above.  Investors, potential investors, and others should give careful consideration to these risks and uncertainties.

For more information, please contact: Aimee Genzler Director, Corporate Communications 978-646-1553 agenzler@abiomed.com Ingrid Goldberg Director, Investor Relations igoldberg@abiomed.com

SOURCE
http://investors.abiomed.com/releasedetail.cfm?ReleaseID=964113

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FDA approved Absorb GT1 Bioresorbable Vascular Scaffold System (BVS), Everolimus releasing and Absorbed by the body in 3 years

Reporter: Aviva Lev-Ari, PhD, RN

FDA approves first absorbable stent for coronary artery disease

For Immediate Release

July 5, 2016

Release

The U.S. Food and Drug Administration today approved the first fully absorbable stent to treat coronary artery disease. The Absorb GT1 Bioresorbable Vascular Scaffold System (BVS), which releases the drug everolimus to limit the growth of scar tissue, is gradually absorbed by the body in approximately three years.

“The FDA’s approval of the Absorb GT1 BVS offers a new treatment option for individuals who are candidates for angioplasty, but would prefer an absorbable device rather than a permanent metallic coronary stent,” said Bram Zuckerman, M.D., director of the division of cardiovascular devices at the FDA’s Center for Devices and Radiological Health.

Coronary heart disease is responsible for about 370,000 deaths each year in the U.S., according to the National Heart, Lung, and Blood Institute. The condition develops when cholesterol-containing deposits build up and narrow the coronary arteries, decreasing blood flow to the heart. This can cause chest pain (angina), shortness of breath, fatigue or other heart disease symptoms. Doctors often treat coronary artery disease with a procedure called angioplasty to widen the artery using a metal stent. Scar tissue can form within the stent causing the artery to narrow again (restenosis). Drug-eluting stents temporarily release a drug, typically for a few months after stent placement, to combat the formation of scar tissue.

The Absorb GT1 BVS is manufactured from a biodegradable polymer called poly(L-lactide), which is similar to materials used in other types of absorbable medical devices, such as sutures. The device’s absorption by the body gradually eliminates the presence of foreign material in the artery once the stent is no longer needed. After absorption, there are only four very small platinum markers embedded in the walls of the artery, which help cardiologists identify where the Absorb GT1 BVS was originally placed.

In approving the Absorb GT1 BVS, the FDA evaluated data from a randomized trial of 2,008 patients, which compared the rate of major adverse cardiac events between the Absorb GT1 BVS and a drug-eluting metallic stent. After one year, the Absorb GT1 BVS group showed a major cardiac adverse event rate of 7.8 percent, which was clinically comparable to the rate of 6.1 percent observed in the control group. In addition, after one year, the rate of blood clots forming within the devices was 1.54 percent for the Absorb GT1 BVS and 0.74 percent rate for the control.

Possible adverse events that may be associated with the procedure to insert the Absorb GT1 BVS or with the Absorb GT1 BVS itself include allergic reactions to materials in the device or medications used during the procedure, allergic reaction to the drug everolimus, infection or irritation at the catheter insertion site, internal bleeding, the development of abnormal connections between arteries and veins, embolism, or other coronary artery complications that may require medical intervention and that could lead to death.

The Absorb GT1 BVS is contraindicated for patients who have a known hypersensitivity or allergy to everolimus or the materials used in the device, such as poly(L-lactide), poly(D,L-lactide), or platinum. It is also contraindicated for those who are not candidates for angioplasty, have sensitivity to contrast, or who cannot take long-term aspirin therapy along with other blood-thinning medications (antiplatelet agents).

The Absorb GT1 BVS is manufactured by Abbott Vascular in Santa Clara, California.

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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Page Last Updated: 07/05/2016

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Previously undiscerned value of hs-troponin

Curators: Larry H. Bernstein, MD, FCAP and Aviva Lev-Ari, PhD, RN

 

UPDATED on 8/14/2018

Siemens Launches High-sensitivity Troponin Test for Faster Diagnosis of Heart Attacks

The new troponin I assays can detect lower levels of troponin compared to conventional testing

July 25, 2018 — The U.S. Food and Drug Administration (FDA) cleared Siemens Healthineers high-sensitivity troponin I assays (TnIH) for the Atellica IM and ADVIA Centaur XP/XPT in vitro diagnostic analyzers from Siemens Healthineers to aid in the early diagnosis of myocardial infarctions.

The new tests can shorten the time doctors need to diagnose a life-threatening heart attacks. The time to first results is 10 minutes. When a patient experiencing chest pain enters the emergency department, a physician orders a blood test to determine whether troponin is present. As blood flow to the heart is blocked, the heart muscle begins to die in as few as 30 to 60 minutes and releases troponin into the bloodstream.

The company said its high-sensitivity performance of the two new Siemens TnIH assays offers the ability to detect lower levels of troponin at significantly improved precision at the 99th percentile, and detect smaller changes in a patient’s troponin level as repeat testing occurs. This design affords clinicians greater confidence in the results with precision that provides the ability to measure slight, yet critical, changes to begin treatment.[1,2]

Chest pain is the cause of more than 8 million visits annually nationwide to emergency departments, but only 5.5 percent of those visits lead to serious diagnoses such as heart attacks.[3] Armed with data to properly triage patients sooner or to exclude myocardial infarctions, the Siemens Healthineers TnIH assays can help support testing initiatives tied to improving patient experience.

“Our emergency department is overcrowded with patients. If we can do a more efficient job at triaging patients to receive the proper level of care and to discharge the patients who do not need to stay in the emergency department, this will have a tremendous economic advantage for our healthcare system,” said Alan Wu, M.D., chief of clinical chemistry and toxicology at Zuckerberg San Francisco General Hospital and Trauma Center.

Siemens is launching the product at the 70th AACC Annual Scientific Meeting and Clinical Lab Expo taking place July 31 to Aug. 2 in Chicago.

For more information: http://www.siemens-healthineers.com

Watch the related VIDEO: Use of High Sensitivity Troponin Testing in the Emergency Department — Interview with James Januzzi, M.D., Massachusetts General Hospital

SOURCE

https://www.dicardiology.com/product/siemens-launches-high-sensitivity-troponin-test-faster-diagnosis-heart-attacks?eid=333021707&bid=2192216

References:

1. Eggers K, Jernberg T, Ljung L, Lindahl B. High-Sensitivity Cardiac Troponin-Based Strategies for the Assessment of Chest Pain Patients—A Review of Validation and Clinical Implementation Studies. Clin Chem. 2018;64(7). DOI: 10.1373/clinchem.2018.287342

2. Collinson P. High-sensitivity troponin measurements: challenges and opportunities for the laboratory and the clinician. Annals of Clinical Biochemistry. 2016;53(2) 191–195. DOI: 10.1177/0004563215619946

3. Hsia RY, Hale Z, Tabas JA. A National Study of the Prevalence of Life-Threatening Diagnoses in Patients With Chest Pain. JAMA Intern Med. 2016;176(7):1029–1032. DOI:10.1001/jamainternmed.2016.2498

 

 

Troponin Rise Predicts CHD, HF, Mortality in Healthy People: ARIC Analysis

Veronica Hackethal, MD

Increases in levels of cardiac troponin T by high-sensitivity assay (hs-cTnT) over time are associated with later risk of death, coronary heart disease (CHD), and especially heart failure in apparently healthy middle-aged people, according to a report published June 8, 2016 in JAMA Cardiology[1].

The novel findings, based on a cohort of >8000 participants from the Atherosclerosis Risk in Communities (ARIC) study followed up to 16 years, are the first to show “an association between temporal hs-cTnT change and incident CHD events” in asymptomatic middle-aged adults,” write the authors, led by Dr John W McEvoy (Johns Hopkins University School of Medicine, Baltimore, MD).

Individuals with the greatest troponin increases over time had the highest risk for poor cardiac outcomes. The strongest association was for risk of heart failure, which reached almost 800% for those with the sharpest hs-cTnT rises.

Intriguingly, those in whom troponin levels fell at least 50% had a reduced mortality risk and may have had a slightly decreased risk of later HF or CHD.

“Serial testing over time with high-sensitivity cardiac troponins provided additional prognostic information over and above the usual clinical risk factors, [natriuretic peptide] levels, and a single troponin measurement. Two measurements appear better than one when it comes to informing risk for future coronary heart disease, heart failure, and death,” McEvoy told heartwire from Medscape.

He cautioned, though, that the conclusion is based on observational data and would need to be confirmed in clinical trials. Moreover, high-sensitivity cardiac troponin assays are widely used in Europe but are not approved in the US.

An important next step after this study, according to an accompanying editorial from Dr James Januzzi (Massachusetts General Hospital, Boston, MA), would be to evaluate whether the combination of hs-troponin and natriuretic peptides improves predictive value in this population[2].

“To the extent prevention is ultimately the holy grail for defeating the global pandemic of CHD, stroke, and HF, the main reason to do a biomarker study such as this would be to set the stage for a biomarker-guided strategy to improve the medical care for those patients at highest risk, as has been recently done with [natriuretic peptides],” he wrote.

The ARIC prospective cohort study entered and followed 8838 participants (mean age 56, 59% female, 21.4% black) in North Carolina, Mississippi, Minneapolis, and Maryland from January 1990 to December 2011. At baseline, participants had no clinical signs of CHD or heart failure.

Levels of hs-cTnT, obtained 6 years apart, were categorized as undetectable (<0.005 ng/mL), detectable (≥0.005 ng/mL to <0.014 ng/mL), and elevated (>0.014 ng/mL).

Troponin increases from <0.005 ng/mL to 0.005 ng/mL or higher independently predicted development of CHD (HR 1.41; 95% CI 1.16–1.63), HF (HR 1.96; 95% CI 1.62–2.37), and death (HR 1.50; 95% CI 1.31–1.72), compared with undetectable levels at both measurements.

Hazard ratios were adjusted for age, sex, race, body-mass index, C-reactive protein, smoking status, alcohol-intake history, systolic blood pressure, current antihypertensive therapy, diabetes, serum lipid and cholesterol levels, lipid-modifying therapy, estimated glomerular filtration rate, and left ventricular hypertrophy.

Subjects with >50% increase in hs-cTnT had a significantly increased risk of CHD (HR 1.28; 95% CI 1.09–1.52), HF (HR 1.60; 95% CI 1.35–1.91), and death (HR 1.39; 95% CI 1.22–1.59).

Risks for those end points fell somewhat for those with a >50% decrease in hs-cTnT (CHD: HR 0.47; 95% CI 0.22–1.03; HF: HR 0.49 95% CI 0.23–1.01; death: HR 0.57 95% CI 0.33–0.99).

Among participants with an adjudicated HF hospitalization, the group writes, associations of hs-cTnT changes with outcomes were of similar magnitude for those with HF with preserved ejection fraction (HFpEF) and HF with reduced ejection fraction (HFrEF).

Few biomarkers have been linked to increased risk for HFpEF, and few effective therapies exist for it. That may be due to problems identifying and enrolling patients with HFpEF in clinical trials, Dr McEvoy pointed out.

“We think the increased troponin over time reflects progressive myocardial injury or progressive myocardial damage,” Dr McEvoy said. “This is a window into future risk, particularly with respect to heart failure but other outcomes as well. It may suggest high-sensitivity troponins as a marker of myocardial health and help guide interventions targeting the myocardium.”

Moreover, he said, “We think that high-sensitivity troponin may also be a useful biomarker along with [natriuretic peptides] for emerging trials of HFpEF therapy.”

But whether hs-troponin has the potential for use as a screening tool is a question for future studies, according to McEvoy.

In his editorial, Januzzi pointed out several implications of the study, including the possibility for lowering cardiac risk in those with measurable hs-troponin, and that HF may be the most obvious outcome to target. Also, optimizing treatment and using cardioprotective therapies may reduce risk linked to increases in hs-troponin. Finally, long-term, large clinical trials on this issue will require a multidisciplinary team effort from various sectors.

“What is needed now are efforts toward developing strategies to upwardly bend the survival curves of those with a biomarker signature of risk, leveraging the knowledge gained from studies such as the report by McEvoy et al to improve public health,” he concluded.

 

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