FDA provides update on its ongoing investigation into ARB drug products; reports on finding of a new nitrosamine impurity in certain lots of losartan and product recall

The U.S. Food and Drug Administration is updating the public on the agency’s ongoing investigation surrounding the recent voluntary recalls of multiple generic angiotensin II receptor blocker (ARB) drug products used to treat high blood pressure and heart failure. Hetero Labs Ltd. in India has announced a recall of 87 lots of losartan potassium tablets (25 mg, 50 mg and 100 mg). The recalled losartan potassium tablets made by Hetero Labs and distributed by Camber Pharmaceuticals contain the impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). The impurity is a known animal and potential human carcinogen. This is the first ARB recall resulting from the presence of NMBA, which is the third type of nitrosamine impurity detected in ARB medicines.

Recent testing of these recalled lots of losartan potassium tablets showed NMBA levels higher than the FDA’s interim acceptable intake limits. The FDA’s evaluation suggests that the nitrosamines found in ARBs may be generated when specific chemicals and reaction conditions are present in the manufacturing process of the drug’s API, and may also result from the reuse of materials, such as solvents.

“We are deeply concerned about the presence of a third nitrosamine impurity in certain ARB medications, but it’s important to underscore that, based on the FDA’s initial evaluation, the increased risk of cancer to patients with NMBA exposure appears to be the same for NDMA exposure but less than the risk from NDEA exposure. That said, any presence of such impurities in drug products is not acceptable. Over the past few months, the FDA has conducted a major investigation and has worked with drug companies to address the presence of impurities in these products,” said FDA Commissioner Scott Gottlieb, M.D. “Our ongoing effort has determined that the impurities may be generated by specific chemical reactions in the manufacturing process of the drug’s active pharmaceutical ingredients. FDA scientists have developed novel and sophisticated testing methods specifically designed to detect and measure N-Nitrosodimethylamine (NDMA) and N-Nitrosodiethylamine (NDEA) impurities in ARB medicines. Because of the potential for discovering other nitrosamine impurities, we are conducting an extensive organic chemistry analysis to develop novel testing methods to detect additional nitrosamine impurities, including NMBA. We’re continuing to share these testing methods with international regulators, industry and the public to help manufacturers and other regulators evaluate these products for any potential nitrosamine impurity. We are making important strides at understanding how these impurities form and we are continuing to examine if nitrosamine impurities may also arise during the manufacture of other ARB drug products. The FDA is committed to implementing measures to prevent the formation of these impurities during drug manufacturing processes in the future.”

Hetero Labs identified NMBA in lots of losartan potassium during recent testing. NMBA has not been found in previously recalled ARB products; however, the FDA is continuing its investigation. Previously, two other nitrosamine impurities, NDMA and NDEA, were found in drug products containing the active pharmaceutical ingredients valsartan, losartan and irbesartan and those products containing nitrosamines above the interim acceptable limits were recalled.

Recent FDA analyses of NDMA and NDEA in recalled valsartan found that overall, the risk to individual patients is very low, although this doesn’t diminish the significance of this issue or the FDA’s concerns. The agency continues to evaluate the risks nitrosamines pose to patients. The FDA and drug manufacturers continue to test all ARBs for nitrosamine impurities. If NDEA, NDMA, NMBA, or other nitrosamine impurities are found in products at levels above the interim acceptable intake limits, the FDA will work with companies to swiftly remove affected products from the market.

The FDA will continue to update the list of products included in the recall as more information becomes available from ongoing testing. If patients take an ARB drug product, they should check the list periodically, as information may change.

The FDA reminds patients taking an ARB medication from a recalled lot to continue taking their medicine until their doctor or pharmacist provides a replacement or a different treatment option. Any patient taking an ARB from a recalled lot who has not yet spoken to their pharmacist or doctor should do so promptly. Not all ARBs contain nitrosamine impurities.

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.

FDA Clears Test to Analyze Nutrients in Breast Milk

The US Food and Drug Administration (FDA) has cleared for marketing a diagnostic test to measure nutrients in breast milk, including the concentration of fat, carbohydrates, protein, total solids, and energy.

The Miris Human Milk Analyzer

The Miris Human Milk Analyzer (Miris AB) can help with nutritional management of newborns and young infants at risk for growth failure due to prematurity or other medical conditions. Knowing the macronutrient content of the breast milk may help clinicians make informed decisions on how to fortify the breast milk based on the individual needs of the infant, the FDA explained in a news release.

“For the first time, doctors have access to a test to help analyze the nutrients in breast milk. While this test is not for everyone, it has the potential to aid parents and healthcare providers, mainly in a hospital setting, in better assessing the nutrient needs of certain babies who are not growing as expected,” Courtney Lias, PhD, director of the Division of Chemistry and Toxicology Devices in the FDA’s Center for Devices and Radiological Health, said in the release.

The Miris Human Milk Analyzer uses an infrared spectroscopy system to analyze human milk and provide a quantitative measurement of fat, protein, and total carbohydrate content. It can also calculate the total solids and energy content of the milk. It is intended for use by trained personnel in clinical laboratories.

The accuracy of the Miris analyzer was demonstrated in an FDA analysis of 112 samples of human milk tested by the Miris analyzer and by independent methods. Both methods were similarly effective at determining levels of protein, fat, and carbohydrates in the milk.

However, the FDA said certain medications that a nursing mother may be taking could interfere with the test’s ability to accurately measure nutrient levels in breast milk.

The agency advises healthcare providers to carefully evaluate the Miris Human Milk Analyzer test results in conjunction with clinical assessments (such as weight and growth) when creating a nutritional management plan for an infant.

The FDA reviewed the Miris Human Milk Analyzer test through the de novo premarket review pathway, a regulatory pathway for some new types of low- to moderate-risk devices.

Along with this marketing authorization, the FDA is establishing “special controls” that set forth the agency’s expectations in ensuring the accuracy, reliability, and effectiveness of tests intended to measure the nutritional content of human milk to aid in the nutritional management of certain infants.

“These special controls, when met along with general controls, provide a reasonable assurance of safety and effectiveness for tests of this type,” the agency said.

FDA Approves First Digital Inhaler With Tracking App

The US Food and Drug Administration (FDA) has approved the first and only digital inhaler with a built-in sensor that connects to a companion mobile application that can monitor usage as well as strength of the user’s inhalation.

The ProAir Digihaler, from Teva Pharmaceutical Industries, contains albuterol sulfate 117 µg powder for inhalation.

The new inhaler is approved for use in people aged 4 years and older to treat or prevent bronchospasm in individuals with reversible obstructive airway disease and to prevent exercise-induced bronchospasm. The approval is based on review of a supplemental new drug application submitted by Teva to the FDA.

“The digital technology built into ProAir Digihaler provides patients with data on their inhaler use, which may help them to have a more informed dialogue with their healthcare provider regarding their asthma or COPD [chronic obstructive pulmonary disease] management,” Sven Dethlefs, Teva executive vice president, global marketing and portfolio, said in a news release.

“There are 25 million Americans living with asthma, many of whom use inhalers as part of their treatment regimen. Despite advancements in care over the years, we know that many are using their rescue medications incorrectly or too often,” Tonya Winders, president and CEO of the Allergy and Asthma Network, said in the release.

“The FDA approval of ProAir Digihaler is significant because it may help patients track their inhaler usage and provide data that can be used to work more closely with their HCPs [healthcare providers] on their asthma management. This approval is a major step forward and is indicative of how medications are evolving through technological innovations,” Winders said.

Teva said the ProAir Digihaler will be available in 2019 through a small number of “early experience” programs, which will be conducted in partnership with healthcare systems in limited geographic areas, in order to gather real-world experience.

A national launch is planned for 2020.

FDA, IHS Managing Through Partial US Government Shutdown

The chief of the US Food and Drug Administration (FDA) is using his Twitter feed to show how his agency is maintaining certain operations during the current partial government shutdown, from which Congress has spared most other federal medical programs.

“Thank you to the 17 dedicated employees in #FDA’s Division of Food Defense Targeting who are working this weekend through the lapse in funding,” tweeted FDA Administrator Scott Gottlieb, MD, on December 22.

Gottlieb also tweeted about FDA staff continuing their work monitoring the ports through which food and medicines reach the United States. And Gottlieb retweeted a note of thanks sent Saturday to the FDA by a Washington University cancer specialist about quick action of the compassionate use program, through which patients facing serious illness can gain access to experimental drugs.

In another tweet, Gottlieb noted the “dedication and commitment” of his agency’s staffers “as they work through a holiday, with diminished resources, to fulfill key elements of FDA’s mission.”

The FDA’s short-term budget woes stem from a political battle between congressional Democrats and President Donald J. Trump over his bid for funding for a border wall, as well as a quirk in congressional appropriations.

Most of the Department of Health and Human Service’s (HHS) budget is funded through a spending bill that also covers the Education and Labor departments. Congress managed to successfully bundle the latest Labor-HHS-Education bill with Defense Department appropriations. Trump signed this roughly $855 billion fiscal 2019 spending package into law days before the new budget year began. That law provided most of the funding needed for the National Institutes of Health, the Centers for Disease Control and Prevention, and other major federal health agencies.

Left out of this massive spending package, though, were the Department of Agriculture appropriations bill, which funds the FDA, and the Department of Interior bill, which funds the Indian Health Service.

Even with disruptions in the flow of funding to FDA, IHS, and other health agencies, though, certain federal workers would still be expected to report for duty, HHS said in the memo.

“Put another way, more than 76% of HHS employees would be retained and 24% would be furloughed,” HHS said in the memo about planning for a fiscal 2019 partial shutdown.

In the memo, HHS said IHS would continue to provide direct clinical healthcare services during a partial shutdown as well as referrals for contracted services that cannot be provided through IHS clinics.

But IHS “could only perform national policy development and issuance, oversight, and other functions necessary to meet the immediate needs of the patients, medical staff, and medical facilities,” HHS said.

In a release dated December 21, the IHS told leaders of Native American tribes that the partial shutdown will temporarily cut off the flow of funding to them to cover agreements with the agency.

“We acknowledge that this circumstance may result in insufficient funds to carry out the terms” of agreements connected to the Indian Self-Determination and Education Assistance Act (ISDEAA), the IHS said in the notice to tribal leaders.

Still, in general, the effects of the partial shutdown may be difficult to detect in the early days. In an interview with Fox News Sunday, Office of Management and Budget Director Mick Mulvaney noted that the shutdown took effect on a weekend and will continue through December 24 and 25, when agencies would be closed anyway for Christmas.

“Wednesday is really the first day this kicks in,” said Mulvaney, who will be the next White House chief of staff.

He also told Fox News that the budget stalemate over border wall funding may continue into January, when the Democrats will take control of the House of Representatives.

“There’s a chance we go into the next Congress” with the partial shutdown continuing, said Mulvaney, who is a former member of the House.

FDA warns some antibiotics can cause fatal heart damage

NBC: FDA warns some antibiotics can cause fatal heart damage

Last week, the FDA announced that certain Fluoroquinolone antibiotics might “raise the risk of an aortic dissection.”1 Fluoroquinolones, which are a commonly prescribed to treat upper respiratory infections and urinary tract infections, include ciprofloxacin (Cipro), levofloxacin (Levaquin), gemifloxacin (Factive) and moxifloxacin (Avelox).

The FDA said in a statement,

“A U.S. Food and Drug Administration (FDA) review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta. These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death.

Fluoroquinolones should not be used in patients at increased risk unless there are no other treatment options available. People at increased risk include those with a history of blockages or aneurysms (abnormal bulges) of the aorta or other blood vessels, high blood pressure, certain genetic disorders that involve blood vessel changes, and the elderly.”2

(This also includes those at risk for an aortic aneurysm, patients with peripheral atherosclerotic vascular diseases, hypertension, certain genetic conditions such as Marfan syndrome and Ehlers-Danlos syndrome (which I have), and the elderly.)

This new information will be added to the labels and prescribing information of fluoroquinolone drugs, according to the FDA. They also stressed that they should only be used when absolutely necessary.

Please be careful. High blood pressure is the main cause of aortic dissection so if you have high blood pressure, discuss this with your doctor before using fluoroquinolones. And if you are taking this class of antibiotic and feel sudden, severe, and constant pain in the stomach, chest or back, call 911 and get to an emergency room as quickly as possible.


Fluoroquinolones can cause serious heart damage, FDA warns


As Overdose Deaths Soar To Record Highs, FDA Approves New Painkiller 1,000x MORE Powerful Than Morphine


Purdue Pharma and other pioneers of powerful opioid painkillers probably felt a twinge of regret on Friday when the FDA approved a powerful new opioid painkiller that’s 10 times stronger than fentanyl  – the deadly synthetic opioid that’s been blamed for the record number of drug overdose deaths recorded in 2017 – and 1,000 times more powerful than morphine, ignoring the objections of lawmakers and its own advisory committee in the process.

After all that trouble that purveyors of opioids like Purdue and the Sackler family went to in order to win approval –doctoring internal research and suborning doctors to convince the FDA to approve powerful painkillers like OxyContin despite wildly underestimating the drug’s abuse potential – the agency might very well have approved those drugs any way? And opioid makers might have been able to avoid some of the legal consequences stemming from this dishonesty, like the avalanche of lawsuits brought by state AGs.

What’s perhaps even more galling is that the FDA approved the drug after official data showed 2017 was the deadliest year for overdose deaths in US history, with more than 70,000 recorded drug-related fatalities, many of which were caused by powerful synthetic opioids like the main ingredient in Dsuvia, the brand name under which the new painkiller will be sold.

Dsuvia is a 3-millimeter tablet of sufentanil made by AcelRx. It’s a sublingual tablet intended to provide effective pain relief in patients for whom most oral painkillers aren’t effective. The FDA’s advisory committee voted 10-3 to recommend approval of the drug, a decision that was accepted by the FDA on Friday. The agency justified its decision by insisting that Dsuvia would be subject to “very tight” restrictions.

“There are very tight restrictions being placed on the distribution and use of this product,” said FDA Commissioner Scott Gottlieb in a written statement Friday regarding his agency’s approval of Dsuvia. “We’ve learned much from the harmful impact that other oral opioid products can have in the context of the opioid crisis. We’ve applied those hard lessons as part of the steps we’re taking to address safety concerns for Dsuvia.”

Still, some of the agency’s actions looked to critics like attempts to stifle internal criticism. For example, the agency scheduled the advisory committee vote on a day where the chairman of the committee, who was opposed to approval, could not attend – while circumventing its normal vetting process, despite the fact that the member in question had notified the agency of his unavailability months beforehand.

But the FDA rejected any and all criticisms related to Dsuvia being sold as a street drug by insisting that the risk of diversion (when doctor-prescribed drugs are illicitly sold on the black market) was low because the drug would only be prescribed in hospital settings, and wouldn’t be doled out at pharmacies. But critics said that, given its potency, Dsuvia would “for sure” be diverted at some level. They also rejected the FDA’s argument that Dsuvia satisfied an important need for pain treatment: offering rapid, effective relief for obese patients or others lacking easily accessible veins.

While a niche may eventually be found for Dsuvia, “it’s not like we need it…and it’s for sure, at some level, going to be diverted,” said Dr. Palmer MacKie, assistant professor at the Indiana University School of Medicine and director of the Eskenazi Health Integrative Pain Program in Indianapolis. “Do we really want an opportunity to divert another medicine?”

Fortunately for Dsuvia’s manufacturer, AcelRx, these public health risks pale in comparison to the enormous profits that the company stands to reap from sales. The company anticipates $1.1 billion in annual sales, and hopes to have its product in hospitals early next year.

It goes without saying that cancer patients and others suffering from life threatening illnesses have a legitimate need for effective pain relief. But when the FDA says Dsuvia is needed in the hospital setting, it probably isn’t telling the whole story. Because, as the Washington Post pointed out, the medication’s development was financed in part by the Department of Defense, which believes Dsuvia will be an effective treatment for emergency pain relief on the battlefield – like when a soldier gets his legs blown off after accidentally stepping on an IUD.

Fluoroquinolone Antibiotics: Safety Communication – Increased Risk of Ruptures or Tears in the Aorta Blood Vessel in Certain Patients

ISSUE: FDA review found that fluoroquinolone antibiotics can increase the occurrence of rare but serious events of ruptures or tears in the main artery of the body, called the aorta.  These tears, called aortic dissections, or ruptures of an aortic aneurysm can lead to dangerous bleeding or even death.  They can occur with fluoroquinolones for systemic use given by mouth or through an injection.

BACKGROUND: Fluoroquinolone antibiotics are approved to treat certain bacterial infections and have been used for more than 30 years.  They work by killing or stopping the growth of bacteria that can cause illness.  Without treatment, some infections can spread and lead to serious health problems (see List of Currently Available FDA-Approved Systemic Fluoroquinolones).

Healthcare professionals should:

  • Avoid prescribing fluoroquinolone antibiotics to patients who have an aortic aneurysm or are at risk for an aortic aneurysm, such as patients with peripheral atherosclerotic vascular diseases, hypertension, certain genetic conditions such as Marfan syndrome and Ehlers-Danlos syndrome, and elderly patients.
  • Prescribe fluoroquinolones to these patients only when no other treatment options are available.
  • Advise all patients to seek immediate medical treatment for any symptoms associated with aortic aneurysm.
  • Stop fluoroquinolone treatment immediately if a patient reports side effects suggestive of aortic aneurysm or dissection.

Patients should:

  • Seek medical attention immediately by going to an emergency room or calling 911 if you experience sudden, severe, and constant pain in the stomach, chest or back.
  • Be aware that symptoms of an aortic aneurysm often do not show up until the aneurysm becomes large or bursts, so report any unusual side effects from taking fluoroquinolones to your health care professional immediately.
  • Inform your health professional before starting an antibiotic prescription,  if you have a history of aneurysms, blockages or hardening of the arteries, high blood pressure, or genetic conditions such as Marfan syndrome or Ehlers-Danlos syndrome.
  • Not stop the antibiotic without first talking to your health care professional.

Canada Says Talc May be ‘Harmful to Human Health’

The government of Canada is considering measures that would prohibit or restrict the use of talc in some products. After reviewing the latest science and producing a draft screening assessment, the government “proposes that inhaling loose talc powders and using certain products containing talc in the female genital area may be harmful to human health.”

The announcement was made Wednesday on the Health Canada website.

The draft screening assessment will be published in the Canada Gazette, Part I, and will be open for public comment for 60 days, until February 6, 2019. The Risk Management Scope , which outlines the possible measures to manage the risks identified in the draft screening assessment, will also be open for public comment for the same 60-day period.

The final screening assessment and risk management approach will take into consideration any comments and new evidence received during the consultation period, the announcement notes.

No action, such as warning labels or a ban, will be taken until this final assessment is published, according to news reports.

The document notes that the draft assessment did not identify human health risks of concern from oral exposures, including talc in food and drugs; dermal exposures such as the application of talc-containing products to skin; or inhalational exposures from dry hair shampoo or pressed powder products, such as cosmetics like eye shadow and blush.

However, the assessment did identify two exposure scenarios of potential concern to human health.

One was inhalation of fine particles of talc during the use of loose powder, self-care products (eg, body powder, baby powder, face powder, foot powder), potentially resulting in damage to the lungs.

The other scenario of concern was exposure of the female perineal area, which includes the genitals, to self-care products containing talc (eg, body powder, baby powder, diaper and rash creams, genital antiperspirants and deodorants, body wipes, bath bombs), as this type of exposure has been associated with ovarian cancer in studies of the human population, the document notes.

Move Comes Amid Great Controversy, US Lawsuits

The move from Canada comes amid a growing controversy, as well as fiercely fought court battles in the United States, over whether use of talc in the female genital area contributes to ovarian cancer.

The controversy is over whether talc itself is a carcinogen, and the issue is complicated because talc is sometimes contaminated with asbestos (the two sometimes occur naturally together).

The scientific community has not reached a consensus.

A recent review appearing in the European Journal of Cancer Prevention ( Eur J Cancer Prev. 2008;17:139–146.) concludes that “data collectively do not indicate that cosmetic talc causes ovarian cancer.” The heterogeneity in the perineal dusting studies has raised important concerns over the validity of the exposure measurements, and the lack of a consistent dose–response effect limits making causal inferences. Perhaps more importantly, it is unknown whether external talc dust enters the female reproductive tract, and measures of internal talc exposure such as talc-dusted diaphragms and latex condoms show no relationship with ovarian cancer risk. Talc is not genotoxic, and mechanistic, pathology and animal model studies have not found evidence for a carcinogenic effect, the journal adds.

However, a recent review in Epidemiology ( Epidemiology. 2018;29:41–49 ), concluded that “in general, there is a consistent association between perineal talc use and ovarian cancer.” This was based on a meta-analysis of observational studies that included at least 50 cases of ovarian cancer, and looked at 24 case–control studies (13,421 cases) and three cohort studies (890 cases, 181,860 person-years).

In the US, thousands of lawsuits have been filed by individuals, or the families of deceased individuals, alleging that ovarian cancer was caused by the use of talc products such as Baby Powder and Shower-to Shower manufactured by Johnson & Johnson. The company is reported to be facing more than 10,000 plaintiffs.

Many of the lawsuits that have already taken place have found for the plaintiffs, but not all.

For example, a jury in Missouri ordered Johnson & Johnson to pay $72 million in damages to the family of Jacqueline Fox, who died from ovarian cancer. However, in two cases juries on appeal overturned multimillion dollar awards: Gloria Ristesund of South Dakota was originally awarded $55 million in 2016, but in June the verdict was overturned. In August 2017, a jury in Los Angeles awarded $417 million to Eva Echeverria, but that verdict was overturned 2 months later.

A lawsuit in October 2018 involving a New Jersey woman cleared Johnson & Johnson of liability in a case of mesothelioma and the company’s baby powder product.

In one of the most recent cases, Johnson & Johnson was ordered in July to pay $4.7 billion to 22 women and their families, who claimed that asbestos in the company’s talc products led them to develop ovarian cancer.  The company said the verdict was ‘fundamentally unfair’ and says that its talc products do not contain asbestos.

Talc–Asbestos Connection Explained 

Talc is a naturally occurring mineral, mined from the earth, composed of magnesium, silicon, oxygen, and hydrogen, explains the Food and Drug Administration. It also notes that asbestos, another naturally occurring silicate mineral, may be found in close proximity in the earth, and so mining sites should be selected carefully. “Unlike talc, however, asbestos is a known carcinogen,” the agency notes.

The FDA says that “it continues to investigate and monitor reports of asbestos contamination in certain cosmetic products,” and notes that talc is used in many cosmetic products, including baby powder and makeup such as powder blush and eye shadow.

The American Cancer Society explains that asbestos does sometimes occur naturally in talc, but guidelines issued in the US in 1976 called for the removal of asbestos from commercial talc products.

However, many consumer groups note that this is an area that is not officially regulated, and report that makeup products sold in the United States that have been found to contain asbestos/talc. Consumer groups also point out that talc in cosmetics has been removed by the European Union, but is still allowed in the United States.

The American Cancer Society also emphasizes that it is important to distinguish between the two. Talc that contains asbestos is generally accepted as being able to cause cancer if it is inhaled. However, the evidence about asbestos-free talc is less clear, it notes.

It also cites the conclusions made by the International Agency for Research on Cancer (IARC), which is part of the World Health Organization (WHO).

The IARC classifies talc that contains asbestos as “carcinogenic to humans.”

Based on the lack of data from human studies and on limited data in lab animal studies, IARC classifies inhaled talc not containing asbestos as “not classifiable as to carcinogenicity in humans.”

As there is limited evidence from human studies showing a link to ovarian cancer, IARC classifies the perineal (genital) use of talc-based body powder as “possibly carcinogenic to humans.”

The US National Cancer Institute says that the “the weight of evidence does not support an association between perineal talc exposure and an increased risk of ovarian cancer. ”

New Documentary Traces History of SynCardia Total Artificial Heart

Produced by Retro Report for The New York Times, film traces the modern-day SynCardia Heart full circle from its origins as a permanent heart to successfully pioneering use as a bridge to transplant to a new FDA clinical study for permanent use.


SynCardia Total Artificial Heart, TAH-t, documentary, Retro Reports, The New York Times


A new documentary produced by Retro Report for The New York Times looks at the history and modern use of the SynCardia temporary Total Artificial Heart (TAH-t). The 12-minute film, “A Change of Heart,” re-examines this leading story of the past and brings viewers through to today’s news.

This documentary details the development of the SynCardia Total Artificial Heart and its direct predecessor, the Jarvik 7. Like a heart transplant, the TAH-t is the only approved device that eliminates end-stage biventricular (both sides) heart failure. This fatal condition results when the native heart’s two ventricles can no longer pump enough blood for a patient to survive.

Through personal stories of surgeons and SynCardia Total Artificial Heart patients, this documentary takes the audience from the first use of a Total Artificial Heart for permanent use in 1982 to today’s use as a bridge to a donor heart transplant.

“Use of SynCardia’s Total Artificial Heart Technology has gone full circle,” said Michael P. Garippa, SynCardia’s CEO and president. “The first implants were for permanent use. For the last 30 years the TAH-t has been used as a bridge to transplant. Now we are in an FDA [U.S. Food and Drug Administration] Investigational Device Exemption (IDE) clinical study for 19 destination therapy patients who do not qualify for a donor heart transplant.”

“This study is generating data on the effective use of the SynCardia Heart as a way for patients to recover from heart failure and continue with a near-normal lifestyle without a human heart,” Garippa said.

The 70cc SynCardia Total Artificial Heart, when used for destination therapy, is an investigational device, limited by United States law to investigational use.

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