New Smaller SynCardia Artificial Heart waiting FDA approval

Press Release

New Smaller SynCardia Total Artificial Heart

Will Expand Life-Saving Therapy to
All Adults & Many Adolescents

Once Results of Studies Are Approved by the FDA, the Smaller 50cc SynCardia Heart and
New Permanent Use Indication Will Triple the Number of Heart Failure Patients Who Can Get a 2nd Chance at Life

The 70cc SynCardia Total Artificial Heart, left, has been implanted in nearly 1,300 patients world-wide. The smaller 50cc SynCardia Heart, right, which could go to clinical trials this year pending FDA approval, is designed to fit in heart failure patients of smaller stature, including most women and many adolescents.

TUCSON, Ariz. – March 11, 2014 –Recent developments surrounding the SynCardia temporary Total Artificial Heart will make the life-saving device available to three times the number of people suffering from end-stage biventricular heart failure. Over 300 SynCardia Hearts have been implanted worldwide since 2012.

Clinical trials awaiting FDA approval will document the use of a new smaller 50cc version of the SynCardia Total Artificial Heart, making it available to people of smaller size, including most women, men and many adolescents.

The current 70cc SynCardia Total Artificial Heart, the world's first and only FDA, Health Canada and CE approved Total Artificial Heart, is approved as a bridge to transplant. It has been implanted in nearly 1,300 people worldwide.

Once approved by the FDA, the studies are expected to launch later this year. They will also investigate using the SynCardia Heart for permanent use (also known as destination therapy). This allows patients who do not qualify for a donor heart transplant — because of other health conditions or age — to receive a SynCardia Heart.

About 3,800 people wait for a heart transplant on any given day, according to the U.S. Department of Health & Human Services. The need for donor hearts is increasing, however. For over 20 years, the supply of approximately 2,300 donor hearts annually has been flat in the U.S. and the supply has generally been declining in Europe. Approximately 16% of people on the heart transplant list become too ill or die each year.

Many patients have lived with the SynCardia Heart for months or years while waiting for a matching donor heart. Thelongest a patient has lived with a SynCardia Heart was nearly four years before receiving a successful donor heart transplant. The SynCardia Total Artificial Heart is one of the most reliable approved heart devices. The valves in the heart have never failed and the diaphragms that pump the blood have a failure rate of less than 1% for nearly 1,300 implanted hearts, accounting for 2,600 ventricles.

Once the clinical trials are underway, both the 50cc and 70cc SynCardia Total Artificial Heart will be available as both destination therapy and bridge to transplant at study sites. The 70cc SynCardia Heart as a bridge to transplant is available at all SynCardia Certified Centers. Like a human heart transplant, the SynCardia Heart eliminates the symptoms and source of end-stage biventricular heart failure, when the left and right ventricles can no longer pump enough blood for the patient to survive.

Watch the Arizona Illustrated video on SynCardia Total Artificial Heart developments

SynCardia CEO and President Michael P. Garippa and Chief Technology Officer Rich Smith detailed these developments in a March 4, 2014 segment of “AZ Illustrated Science,” a Tucson Arizona news and public affairs show that airs on Public Broadcasting. They also provided an update about the Freedom® portable driver, which powers the SynCardia Heart.

The Freedom® portable driver, at only 13.5 pounds, provides patients with almost unlimited mobility. It is pending FDA approval and is approved by Health Canada and the CE Mark for Europe. A majority of clinically stable patients are discharged with the Freedom portable driver to recover at home and in their communities. At home, patients are able to sleep in their own beds, eat out, socialize and be part of their communities. Most patients exercise, helping them become stronger for their donor heart transplant.

“Freedom patients have proven that many activities and daily living are possible, including activities that we don’t necessarily endorse,” Garippa says of some patients. “We’ve had people go four-wheeling. We’ve had people doing tai chi. We’ve had people cycle, run, take driving vacations through many states and countries and do everything but swim.”

The 50cc Total Artificial Heart is designed for use as a bridge to transplant in patients of smaller stature, including women and adolescents. It has been designated as a Humanitarian Use Device (HUD) by the FDA for destination therapy in adults and as a bridge to transplant in pediatric patients. Prior to clinical study, an Investigational Device Exemption (IDE) application that includes each indication must be approved by the FDA.

CAUTION – The Freedom portable driver is an investigational device, limited by United States law to investigational use.

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About the SynCardia temporary Total Artificial HeartSynCardia Systems, Inc. (Tucson, AZ) is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. Originally used as a permanent replacement heart, the SynCardia Total Artificial Heart is currently approved as a bridge to transplant for people suffering from end stage heart failure affecting both sides of the heart (biventricular failure). There have been more than 1,250 implants of the Total Artificial Heart, accounting for more than 350 patient years of life on the device.

Similar to a heart transplant, the SynCardia Total Artificial Heart replaces both failing heart ventricles and the four heart valves. It is the only device that eliminates the symptoms and source of end stage biventricular failure. Unlike a donor heart, the Total Artificial Heart is immediately available at 97 SynCardia Certified Centers worldwide with 39 others in the process of certification.

The Total Artificial Heart provides immediate, safe blood flow of up to 9.5 liters per minute through each ventricle. This high volume of blood flow helps speed the recovery of vital organs, helping make the patient a better transplant candidate.

For up-to-date information, please visit: http://www.syncardia.com
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An artificial heart offers a real chance

Read my previous post about Syncardia being awarded Arizona's Bioscience Company of the Year for their artificial heart and driver.

After years of declining health, Tammy Lumpkins becomes the first West Coast patient to be released from the hospital after receiving an artificial heart. The device will buy her some time until she can get a transplant.

Tammy Lumpkins packs up an extra Freedom Drive System, which powers her artificial heart.“I was ready to give up last summer,” she said. “Now there’s a light at the end of the tunnel and it’s getting brighter.” (Genaro Molina, Los Angeles Times / November 8, 2011)
By Anna Gorman, Los Angeles Times
When 46-year-old Tammy Lumpkins showed up at Keck Hospital of USC in August, she needed a new heart.

Her doctors got her onto the transplant list, but as she waited, her health deteriorated. Her liver and kidneys started to fail and she couldn't get out of bed.

"To say she was on the brink of death was an understatement," said Dr. Michael Bowdish, a cardiothoracic surgeon at Keck Hospital.

Photos: A New Heart

So in late September, Bowdish implanted an artificial heart in Lumpkins to replace both of the organ's chambers and all four valves. And on Wednesday, Lumpkins will become the first person on the West Coast to leave the hospital with such a device.

Lumpkins said she feels lucky to be alive and grateful to be leaving the hospital. Now she can watch her 19-year-old son graduate from ITT Technical Institute in December. And after nearly 20 years with heart problems, Lumpkins said Tuesday that she had renewed confidence that she would finally get better.

"I was ready to give up last summer," she said, sitting beside her husband in front of the hospital. "Now there's a light at the end of the tunnel and it's getting brighter."

Although artificial hearts aren't new, patients have traditionally had to stay in the hospital because the machine necessary to make them work weighed more than 400 pounds. Now, new technology allows patients to go home while they wait for heart transplants. The device, which weighs almost 14 pounds, can be carried in a small backpack.

"She can go home and live a normal life," said Bowdish, who directs the hospital's artificial heart program.

More than 950 people have received artificial hearts and 22 people in the United States have gone home with the lightweight devices, according to Don Isaacs, spokesman for SynCardia, the Tucson-based company that manufacturers the artificial heart. The device costs about $124,000 and an additional $18,000 a year to maintain, Isaacs said. Although the heart is approved by the Food and Drug Administration, the backpack device is part of a clinical trial.

Patients can live with the artificial heart for years, although the goal is to get them transplants as soon as possible. "But the reality is there's a wait, and sometimes a long wait," he said.

More than 3,100 patients are waiting for heart transplants. The average wait is 168 days, according to the United Network for Organ Sharing.

"The supply doesn't meet the demand," said Dr. Kathy E. Magliato, a cardiothoracic surgeon and president of the American Heart Assn. board in Los Angeles. An artificial heart can save the lives of patients who cannot wait for transplants, she said.

Lumpkins, who lives near Modesto, was 28 when she was diagnosed with cardiomyopathy, a disease that weakens and enlarges the heart. Five years later, doctors told her she had congestive heart failure. Since early 2010, Lumpkins said, she has been in and out of the hospital. Her husband, Dale, an electrician, said his insurance will pay for some of the medical bills.

Because she must stay relatively close to the hospital, Lumpkins will live temporarily at a friend's house in Hemet and return weekly for checkups. After the holidays, Bowdish said, he plans to actively start looking for a transplant heart.

With the machine pumping loudly beside her Tuesday, Lumpkins said she was nervous. "It's scary not knowing what's going to happen," she said. "But I'm feeling 100% better than I ever did."

Following the surgery to implant her artificial heart in September, Lumpkins and her husband renewed their wedding vows after 22 years of marriage. "I told her that her new heart had to love me as much as her old heart had," he said.

Photos: A New Heart

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Tell Your Loved Ones of Your Decision”

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other Canadian provinces

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United Kingdom, register at NHS Organ Donor Register

Your generosity can save or enhance the lives of up to fifty people with heart, kidneys, liver, lungs, pancreas and small intestine transplants (see allotransplantation). One tissue donor can help by donating skin, corneas, bone, tendon, ligaments and heart valves

Has your life been saved by an organ transplant? "Pay it forward" and help spread the word about the need for organ donation - In the U.S. another person is added to the national transplant waiting list every 11 minutes and 18 people die each day waiting for an organ or tissue transplant. Organs can save lives, corneas renew vision, and tissue may help to restore someone's ability to walk, run or move freely without pain. Life Begins with You

Total Artificial Heart earns SynCardia "Arizona Bioscience Company of the Year"

SynCardia Honored by Arizona BioIndustry Association for "Doing the Most to Transform the World During the Last 12 Months"

TUCSON, AZ, Oct 18, 2011 (MARKETWIRE via COMTEX) -- On Oct. 13, SynCardia Systems, Inc. (www.syncardia.com), manufacturer of the world's only FDA, Health Canada and CE approved Total Artificial Heart, was named "Arizona Bioscience Company of the Year" by the Arizona BioIndustry Association (AZBio).

"The Arizona Bioscience Company of the Year Award recognizes the for-profit bioscience company whose Arizona-based operations did the most to transform the world during the last 12 months," said AZBio CEO Joan Koerber-Walker. "SynCardia makes it possible for patients awaiting donor hearts to not only survive the wait but also to do so with flexibility and mobility, a feat of biomedical engineering that is world-changing for these patients."

CAUTION - The Freedom(R) portable driver is an investigational device, limited by United States law to investigational use.
SynCardia designed, developed, and introduced the Freedom(R) portable driver, the world's first wearable power supply for the SynCardia temporary Total Artificial Heart. For the first time in U.S. history, stable patients without human hearts are being discharged from the hospital to wait for a matching donor heart at home using the Freedom portable driver to power their Total Artificial Hearts. Weighing 13.5 pounds, the Freedom driver is CE approved for use in Europe and undergoing an FDA-approved Investigational Device Exemption (IDE) clinical study in the U.S.

Prior to the development of the Freedom driver, U.S. Total Artificial Heart patients were confined to the hospital for months, sometimes years, while they waited for a heart transplant because the only FDA-approved driver for powering the Total Artificial Heart is hospital-based "Big Blue" which weighs 418 pounds.

Life for a stable Total Artificial Heart patient confined to the hospital is emotionally, physically and financially draining for them, their family and the hospital. As wait times for a heart transplant continue to lengthen, the ability to discharge stable patients home is critical for both the patient and the hospital. Recovery at home improves patient quality of life while eliminating most in-hospital costs for this portion of patient care.

The other two finalists for the award were Calimmune, Inc., which is developing innovative cell-based therapies for treating HIV, and VisionGate, which has developed an automated 3D cell imaging platform to help detect lung cancer sooner.

AZBio is the state affiliate of the Biotechnology Industry Organization (BIO), the preeminent national association for biotechnology companies, and of AdvaMed, the largest association representing manufacturers of medical devices, diagnostic products and medical information systems.

About the SynCardia temporary Total Artificial Heart SynCardia Systems, Inc. (Tucson, AZ) is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. Originally used as a permanent replacement heart, the Total is currently approved as a bridge to transplant for people dying from end-stage heart failure affecting both sides of the heart (biventricular failure). More than 950 implants account for more than 230 patient years of life.

Similar to a heart transplant, SynCardia's Total Artificial Heart replaces both failing heart ventricles and the four heart valves. It is the only device that eliminates the symptoms and source of end-stage biventricular heart failure and pumps up to 9.5 liters per minute through both ventricles. This high volume of safe blood flow helps speed the recovery of vital organs, helping make the patient a better transplant candidate.

Fast Company ranked SynCardia#20 among the World's 50 Most Innovative Companies "for giving mobility to artificial heart recipients."

Website: www.syncardia.com SynCardia on Facebook Twitter: @SynCardia SynCardia on LinkedIn

“You Have the Power to Donate Life – to become an organ and tissue donor Sign-up today!
Tell Your Loved Ones of Your Decision”

Australia, register at Australian Organ Donor Register

New Zealand, register at Organ Donation New Zealand

Canada - Ontario beadonor.ca
other Canadian provinces

South Africa, http://www.odf.org.za/

United States, organdonor.gov

United Kingdom, register at NHS Organ Donor Register

Your generosity can save or enhance the lives of up to fifty people with heart, kidneys, liver, lungs, pancreas and small intestine transplants (see allotransplantation). One tissue donor can help by donating skin, corneas, bone, tendon, ligaments and heart valves

Has your life been saved by an organ transplant? "Pay it forward" and help spread the word about the need for organ donation - In the U.S. another person is added to the national transplant waiting list every 11 minutes and 18 people die each day waiting for an organ or tissue transplant. Organs can save lives, corneas renew vision, and tissue may help to restore someone's ability to walk, run or move freely without pain. Life Begins with You

40 New Hospitals Have Joined SynCardia's Certification Program to Implant Total Artificial Heart During Past Year

TUCSON, AZ--(Marketwire - Jul 28, 2011) - SynCardia Systems, Inc. (www.syncardia.com), the privately-held manufacturer of the SynCardia temporary Total Artificial Heart, announced today that it has nearly tripled its first-half sales from 2010, posting its first quarterly and first-half profit in company history.

"There are only two companies making money in the mechanical circulatory support industry right now," said Michael Garippa, SynCardia CEO/President. "SynCardia and Thoratec. The Total Artificial Heart continues to become the standard of care for end-stage biventricular heart failure. In the past few weeks, half a dozen world-renowned transplant programs have completed SynCardia Certification and performed their first implants of the Total Artificial Heart. These centers have achieved excellent patient outcomes thus far, especially considering how sick these patients were prior to implant."

During the past year, 40 hospitals have enrolled in SynCardia's Certification Program to implant the Total Artificial Heart. SynCardia is currently conducting an FDA-approved Investigational Device Exemption (IDE) clinical study of the Freedom® driver, the first U.S. portable driver designed to power SynCardia's Total Artificial Heart both inside and outside the hospital. A total of 22 patients have been enrolled so far in the study. Of these patients, 19 have reached study end points of heart transplantation or 90 days of support on the Freedom driver. Twelve have been discharged, which is 40% of the 30 required by the FDA.

The Freedom driver, which is also CE approved for use in Europe, has supported a total of 50 patients worldwide. The most recent patient was transferred to the Freedom driver on July 21, at the Heart & Diabetes Center NRW in Bad Oeynhausen, Germany.

CAUTION - The Freedom® driver is an investigational device, limited by United States law to investigational use.

About the SynCardia temporary Total Artificial HeartSynCardia Systems, Inc. (Tucson, AZ) is the privately-held manufacturer of the world's first and only FDA, Health Canada and CE approved Total Artificial Heart. Originally used as a permanent replacement heart, the Total is currently approved as a bridge to transplant for people dying from end-stage biventricular heart failure. More than 900 implants account for more than 210 patient years of life.

Similar to a heart transplant, SynCardia's Total Artificial Heart replaces both failing heart ventricles and the four heart valves. It is the only device that eliminates the symptoms and source of end-stage biventricular failure. The Total Artificial Heart provides immediate, safe blood flow of up to 9.5 liters per minute through both ventricles. This high volume of safe blood flow helps speed the recovery of vital organs, helping make the patient a better transplant candidate.

In March 2011, Fast Company magazine ranked SynCardia #20 among the World's 50 Most Innovative Companies "for giving mobility to artificial heart recipients." Also in March, the longest running health and wellness series on public television, "Healthy Body, Healthy Mind," produced a 30-minute program featuring SynCardia's Total Artificial Heart. View here

For additional information, please visit: http://www.syncardia.com
or follow SynCardia on Twitter - @SynCardia_News

“You Have the Power to Donate Life – Sign-up today!
Tell Your Loved Ones of Your Decision”

Canada Ontario,
Canada - British Columbia, other Canadian provinces

United States, organdonor.gov

United Kingdom, register at NHS Organ Donor Register

Australia, register at Australian Organ Donor Register

Your generosity can save or enhance the lives of up to fifty people with heart, kidneys, liver, lungs, pancreas and small intestine transplants (see allotransplantation). One tissue donor can help by donating skin, corneas, bone, tendon, ligaments and heart valves

Has your life been saved by an organ transplant? "Pay it forward" and help spread the word about the need for organ donation - In the U.S. another person is added to the national transplant waiting list every 11 minutes and 18 people die each day waiting for an organ or tissue transplant. Organs can save lives, corneas renew vision, and tissue may help to restore someone's ability to walk, run or move freely without pain. Life Begins with You

A change of heart changed her life

Jennifer Monteith had accepted living with a battery-powered heart — then she got an unexpected call. Photo: Lucas Oleniuk, Toronto Star

By Amy Dempsey Toronto Star

On the evening of Jan. 7, Jennifer Monteith decided to celebrate being alive.

“I decided to make myself a fabulous dinner,” she says. “I was at home and I felt like pork chops and mashed potatoes and green beans. And I’d been dying for a glass of wine.”

Monteith had spent more than a year and a half with a mechanical heart — a device attached to her heart’s left ventricle that is powered by a battery pack she carried around in a shoulder bag.

For most people who get one, the LVAD, or left ventricle assist device, is a bridge to a heart transplant. Few need them for longer than six months because a donor heart is usually found by then.

But Monteith was in a difficult situation; doctors had warned her that 98 per cent of all potential donor hearts wouldn’t work because of her unusually high number of antibodies that would cause her body to reject most of them.

“I’d just about given up and I’d settled for the fact that I have an LVAD and it was working good,” she says.

In her Bloor West Village home last January, Monteith prepared for what she calls a “fancy night.” She set the table, cranked the jazz and turned on her fireplace.

Then she got an unexpected call: “We have a heart for you, Jennifer.”

She called one of her sons, who heard the excitement in her voice and asked if she was having one of her fancy moments.

“I said ‘Yes I am. And it’s going to get even fancier.’”

Monteith smiles as she relays memories of her three-year heart journey, but then pauses as tears spill down her cheeks.

“This is taking me back,” she says, mopping her face with a cloth. She chuckles, shakes her head and continues.

Monteith, 57, doesn’t know for sure what weakened her heart, but two years ago she was diagnosed with advanced heart failure.

The irregular rhythm of her heart made sudden death a looming threat. Her doctors say she would have died waiting for a transplant without the LVAD.

More than half a million Canadians suffer from some form of heart disease and more than 50,000 a year are treated for advanced heart failure. Nearly 40 per cent of those patients die within the first year of diagnosis.

Monteith was one of the lucky ones, as just 90 patients have received a mechanical heart from the Peter Munk Cardiac Centre since 2001. The devices cost about $100,000 and are funded by private hospital donors and the Ministry of Health and Long-Term Care.

Dr. Terrence Yau, the surgeon who performed Monteith’s transplant in January, says only a few mechanical heart users in the country had one as long as Monteith.

“We really never thought that we’d get her a heart,” he says.

But then, despite incredible odds, they found a match.

It is possible to live permanently with an LVAD, but Monteith says living with a battery-powered heart was not easy. She had to have a friend or family member with her at all times in case of an emergency and be home to recharge her battery pack every six to eight hours.

She says having to depend on others and ask for help was the hardest part. Monteith raised two boys on her own after her husband died in a car accident nearly 20 years ago and she takes pride in running her own business, a trade show support centre at Exhibition Place. One of her sons helped run the shop when she couldn’t.

The mechanical heart kept her alive, but it stripped her of her independence; the transplant gave Monteith her freedom back.

“I’m home by myself without doctors and machines,” she says. “I’m able to be on my own.”

More tears spill from her brown eyes. “God that is such an amazing thing.”

For the first few nights after she left the hospital in February, Monteith says she couldn’t sleep without the familiar buzz of the power unit that had kept blood pumping through her body for 20 months. It was replaced with a sound she wasn’t used to: the thump of her new heart.

“Can you imagine getting a new heart?” she says. “Somebody else giving you a heart and you are able to go out and have a second chance at life and carry on your dream?”

She laughs, wipes her face again and shakes her head.

“It’s just such a magical feeling. I look forward to my every day.”

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Your generosity can save up to eight lives with heart, kidneys, liver, lungs, pancreas and small intestine transplants (see allotransplantation). One tissue donor can help 75 to 100 other people by donating skin, corneas, bone, tendon, ligaments and heart valves

Has your life been saved by an organ transplant? "Pay it forward" and help spread the word about the need for organ donation - In the U.S. another person is added to the national transplant waiting list every 11 minutes and 18 people die each day waiting for an organ or tissue transplant. Organs can save lives, corneas renew vision, and tissue may help to restore someone's ability to walk, run or move freely without pain. Life Begins with You