Feature | March 28, 2013

Thoratec Announces the First Human Use of HeartMate PHP

March 28, 2013 — Thoratec Corp. announced that it has successfully completed the first human use of HeartMate PHP (percutaneous heart pump). The first PHP patient was supported for over 60 minutes during a high-risk percutaneous coronary intervention (HR PCI). The patient was hemodynamically stable during the procedure, which involved three-vessel intervention on a patient with an ejection fraction less than 30 percent. Two additional patients were treated as part of this first-in-man series. The procedures were performed by Adrian Ebner, M.D. at Sanatorio Italiano in Asuncion, Paraguay. Ebner is the chief of the Cardiovascular Department at Sanatorio Italiano.

The HeartMate PHP system is a catheter-based heart pump designed to provide hemodynamic left ventricular support. Upon insertion into the femoral artery via an integrated 12 French introducer sheath, the PHP catheter is advanced into the left ventricle where the distal end of the catheter expands to 24 French, allowing for enhanced blood flow with low levels of hemolysis. Thoratec has designed the PHP system to facilitate rapid insertion using an intuitive control console and to provide 4-5 liters per minute of mean flow for support durations up to several days.

"We are delighted to have participated in the first human experience with HeartMate PHP," said Ebner. "The PHP technology represents a potential breakthrough in MCS therapy, providing the support required for hemodynamically unstable patients. Without PHP in place during this high-risk procedure, we might not have been able to achieve complete revascularization."

"I am pleased with the level of support the PHP system provided in this milestone case," said Michael Ennen, vice president and general manager of Thoratec's Interventional Business. "In just three years, our team has taken PHP from concept to clinical utilization, and we look forward to advancing our evaluation of this next-generation percutaneous support system."

Thoratec intends to pursue clinical investigations on the use of HeartMate PHP to support patients undergoing high-risk percutaneous interventions as well as those in cardiogenic shock, a population with persistently high mortality rates. The company is planning a continuation of the pilot study during the second quarter and anticipates initiating a CE mark study in the second half of 2013. The PHP system complements Thoratec's surgical-based MCS pump platforms such as HeartMate II and CentriMag, providing a complete continuum of circulatory support products.

"This First-in-Human experience with HeartMate PHP demonstrates Thoratec's commitment to our mission of providing physicians with superior MCS solutions, for both chronic and acute support needs, in order to dramatically improve patient outcomes," said Gary Burbach, Thoratec's president and CEO.

For more information: www.thoratec.com

Related Content

FDA, CDRH, national evaluation system, medical device development
Feature | Business| May 04, 2016
The U.S. Food and Drug Administration (FDA) announced it is building the foundations of a national evaluation system to...
Biotronik, FDA, MR Conditional CRT devices, Iperia HF-T, defibrillator, ProMRI
Technology | Cardiac Resynchronization Therapy Devices (CRT)| May 03, 2016
Biotronik announced U.S. Food and Drug Administration (FDA) approval of Iperia ProMRI HF-T, a cardiac resynchronization...
American Society of Echocardiography, ASE guideline, left ventricular diastolic function, LV, heart failure, JASE
News | Cardiovascular Ultrasound| May 03, 2016
May 3, 2016 — Good news for clinicians and their patients: the evaluation of left ventricular (LV) diastolic function
CardioMEMS, implantable hemodynamic monitor, Fontan anatomy, Nationwide Children's Hospital, Wexner Medical Center
News | Implantable Cardiac Monitor (ICM)| May 02, 2016
In a recent case series, clinicians from The Heart Center at Nationwide Children’s Hospital and The Ohio State...
radiation dose in the cath lab
News | Radiation Dose Management| May 02, 2016
May 2, 2016 — Starting at the Society for Cardiovascular Angiography and Interventions (SCAI) 2016 annual meeting May
Feature | Business| April 28, 2016 | Dave Fornell
 
Technology | Stents Peripheral| April 27, 2016
Veniti Inc. announced the first successful treatment with the Vici Verto Venous Stent System of a patient suffering...
Auris Surgical Robotics, acquisition, Hansen Medical
News | Robotic Systems| April 26, 2016
Auris Surgical Robotics Inc. and Hansen Medical Inc. announced that they have signed a definitive merger agreement...
CABG, bypass surgery, heart failure, NHLBI study
News | Cardiovascular Surgery| April 25, 2016
Scientists have found that a greater number of patients with coronary artery disease may benefit from coronary artery...
Siemens Sensis Vibe, hemodyanamics system

Siemens released the Sensis Vibe hemodyanamics system at ACC.16. The newer system offers better integration of cath lab data into cath lab reports and the electronic medical record (EMR).

Feature | ACC| April 25, 2016 | Jon Brubaker, MBA, RCVT, Tom Watson, BS, RCVT, and Sabrina Newell MS, RCS
There were several trends seen in new cardiovascular technologies showcased on the expo floor at the 2016 American...
Overlay Init