1976 Dr. William S. Pierce, M.D., attached the
first Penn State pneumatic ventricular assist pump to the
heart of a patient who had undergone open heart surgery
at Penn State Hershey Medical Center.
1983 Penn State researchers implanted a
cam-type electric motor artificial heart in a calf named
E.T. who survived for 222 days with an electric total
artificial heart, setting a world record.
1984 A calf survived for 354 days with a Penn
State pneumatic artificial heart, setting a world record
for an experimental animal with an artificial heart.
1985 The Penn State Heart, an air-driven total
artificial heart, is first implanted in a patient.
1986 The Penn State Heart is implanted in its
second patient, who remains on the device for 13 months.
1988 The National Institutes of Health awards
Penn State Milton S. Hershey Medical Center a $5.7
million contract for research to develop an electrical,
artificial heart.
1990 The Penn State Heart-Assist Pump was named
an International Historic Mechanical Engineering Landmark
by the American Society of Mechanical Engineers.
1991 Holly the calf shatters the record for the
longest living calf on any artificial heart. She survives
for one year and 23 days.
1992 Winston the calf ushered in the era of the
wireless, electric total artificial heart living 118 days
on the Penn State device.
1993 Penn State Hershey Medical Center is one
of only three institutions awarded a three-year, $5.4
million contract from the National Heart, Lung, and Blood
Institute to continue work in developing a permanently
implantable electric heart.
1996 Penn State Hershey Medical Center receives
a $7.7 million federal contract awarded for research on
the electromechanical heart.
1998 The Whitaker Foundation awards a grant of
nearly $1 million to the Biomedical Engineering Institute
at Penn State Hershey Medical Center. The institute's
purpose is to add a new educational component to the
bioengineering program at Penn State.
A newly FDA-approved heart assist device, the Vented
Electric Left Ventricular Assist Device, is implanted for
the first time in the country in a patient at Penn State
Hershey Medical Center. The device allows seriously ill
heart patients to survive and wait at home for a heart
transplant. The surgical team is led by surgeon Benjamin
Sun, M.D., who has since left the institution.
1999 As part of a multi-center clinical trial,
a patient on a left ventricular assist device (LVAD) is
placed on a portable driver-control unit that will power
the LVAD. This is the first clinical use of the device in
the United States. The device greatly improves the
patient's mobility allowing her to leave the hospital
while awaiting a heart transplant, according to Walter
Pae, Jr., M.D., professor of surgery at Penn State
College of Medicine and director of cardiac
transplantation at Penn State Hershey Medical Center.
Physicians begin implanting a new heart-assist system
in patients with end-stage heart failure who are not
candidates for transplantation. The new system is totally
implantable and permanent - not a bridge to
transplantation or temporary heart helper. The lead
investigator is Walter E. Pae, Jr., professor of surgery.
The device is called the Arrow LionHeart™ and was
developed at Penn State College of Medicine in
conjunction with Arrow International, Inc., of Reading,
PA.
The first human implant of the Arrow LionHeart™ LVAS
occurred on October 26, 1999 at The Heart and Diabetes
Center in Bad Oeynhausen, Germany.
2001 Arrow receives an Investigational Device
Exemption (IDE) from the U.S. Food and Drug
Administration (FDA) to begin a Phase I human clinical
trial in the United States. The lead investigator for
this pilot study is Dr. Walter Pae of Penn State's
Hershey Medical Center. Other trial sites are: University
of Arizona; University of Pennsylvania; University of
Iowa, Loyola University.
The first U.S. recipient of the LionHeart™ receives
the device February 28, 2001 at Penn State Milton S.
Hershey Medical Center. On July 26, Penn State Hershey
Medical Center reported that the first U.S. patient died.
2002 First part of U.S. Phase I trial
completed.
At the American College of Cardiology 51st Annual
Scientific session held March 2002 in Atlanta, Walter E.
Pae, Jr., M.D., professor of surgery at Penn State
College of Medicine and director of transplantation at
Penn State Milton S. Hershey Medical Center, reported
that nine of the 22 European patients receiving a
LionHeart™ implant prior to March 1, 2002 were alive and
that seven were now living at home. Three of the nine
patients have been living over one year with the
Lionheart™ and one of these three has passed the two year
mark. A fourth patient lived just short of two years with
the device.
FDA approves second set of seven U.S. patients with a
slightly different list of qualifications for patient
inclusion. Also, additional trial sites were added:
Washington Hospital Center, Columbia University,
University of Louisville, and LSS Hospital.
July 31, 2002, University of Iowa physicians implant
the LionHeart into the first patient in the second set of
seven U.S. patients.
2003
May 14 The second U.S.
patient in the second set of Phase I clinical trials
receives Arrow LionHeart at Penn State Milton S. Hershey
Medical Center.
May European Trial closes.
Arrow International applies for CE Mark, the equivalent
of FDA approval in the United States. The CE Mark would
allow the device to be offered in Europe as an option to
patients with end-stage heart failure.
June 23 Gayle Snider of
York, Pa., becomes the first U.S. patient with an Arrow
LionHeart heart assist device to go home from the
hospital.
Fall Gayle Snider takes a
trip to a NASCAR event at Dover Downs, Delaware.
November The first results of
the European trial of the Arrow LionHeart led by Walter
E. Pae Jr., M.D., are unveiled by Pae and John P. Boehmer,
M.D., both from Penn State Hershey Medical Center, at the
American Heart Association’s 76th Scientific
Sessions. The study suggests that fully-implantable
mechanical heart support is possible and reliable. Only
three device failures were recorded in 17.3 years of
support time.
Arrow International, Inc., announces
that it received authorization from its European Notified
Body, TUV Product Services of Munich, Germany, to CE-mark
the Arrow LionHeart, based on the results of the European
trial. The CE-mark provides authorization to market the
device within the European Economic Area for permanent
implantation or “destination therapy”. The Arrow
LionHeart is the first left ventricular assist system to
receive CE-marking authorization specifically for
destination therapy.
2004
January Gayle Snider is added to the heart
transplant list.
May 14 Gayle Snider marks one year milestone with
Arrow LionHeart.
