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

ORSIF, radiation exposure for interventionalists, greater on left side of head, Ehtisham Mahmud
Feature | Radiation Dose Management| October 06, 2015
The results of a research study indicate that interventional cardiologists receive “very high” radiation exposure...
Aortix device, TCT, Interventional Innovation Shark Tank Competition, catheter-based circulatory heart pump

Image courtesy of Procyrion

News | Ventricular Assist Devices (VAD)| October 06, 2015
The novel Aortix device has earned a spot among the diagnostic and therapeutic modalities accepted for presentation in...
Procyrion, Aortix device, grand prize, Create the Future Design Contest

Aortix device image courtesy of Procyrion Inc.

News | Ventricular Assist Devices (VAD)| October 05, 2015
Procyrion Inc. of Houston has been awarded the grand prize of $20,000 in the 2015 "Create the Future" Design Contest...
Synergy stent
Technology | October 05, 2015
October 5, 2015 — The U.S.
News | Heart Failure| October 02, 2015
Cyberonics Inc. announced results from the extension of the ANTHEM-HF clinical study (ENCORE Study). Results of the...
Tryton Side Branch Stent, clinical trial results, Catheterization and Cardiovascular Interventions

Tryton Side Branch Stent image courtesy of Tryton Medical

News | Stents Bifurcation| October 02, 2015
October 2, 2015 — Tryton Medical Inc.
Brilinta, 60 mg dose available, U.S. pharmacies
Technology | Antiplatelet and Anticoagulation Therapies| October 02, 2015
AstraZeneca announced that Brilinta (ticagrelor) 60-mg tablets are now available in U.S. pharmacies. On Sept. 3, 2015,...
Intact Vascular, TOBA II study, Tack Endovascular System

Image courtesy of Intact Vascular

News | Peripheral Arterial Disease (PAD)| October 01, 2015
Intact Vascular Inc. announced the U.S. Food and Drug Administration has granted conditional approval for a U.S. and...
Cook Medical, Zilver PTX, Japan PMS study, CIRSE 2015, two-year results

Image courtesy of Cook Medical

News | Stents Peripheral| October 01, 2015
Kimihiko Kichikawa, M.D., department of radiology at Nara Medical University in Japan, reported two-year results of the...
Stentys, CE Mark for self-apposing stent, lower limb artery disease, below-the-knee arteries, critical limb ischemia, PES BTK-70 trial

Image courtesy of Stentys

News | Stents Peripheral| October 01, 2015
Stentys announced that the company’s drug-eluting stent received CE Mark for treatment of below-the-knee (BTK) arteries...
Overlay Init