HeartWare begins clinical trial of less-invasive surgical approach for its devices

HeartWare ($HTWR) announced the first implant of its HeartWare Ventricular Assist System and HVAD Pump using the less-invasive thoracotomy procedure in patients in its HVAD Lateral clinical trial of end-stage heart failure patients who are waiting for a heart transplant.

HVAD pump--Courtesy of HeartWare International

The goal of the study is to examine the outcomes of the less invasive surgical approach to implantation, which involves placing the HVAD pump near the heart via a small, lateral incision between the patient's ribs on the left side of the chest, explains the release.

In contrast, the conventional approach calls for a vertical incision through the center of the patient's chest.

"The thoracotomy implant technique holds considerable promise for making implantation easier for the surgeon and better tolerated by the patient," said Dr. Ed McGee, head of the heart transplant and assist device program, professor in the Department of Thoracic and Cardiovascular Surgery at Loyola University Chicago Stritch School of Medicine, and a co-principal investigator for the HVAD Lateral Study. "Implantation via thoracotomy allows for preservation of a sternotomy for a heart transplant, making that subsequent surgery less difficult for the bridge-to-transplant patient."

The trial will eventually enroll up 120 patients at 30 U.S. hospitals. Its population will consist of end-stage heart failure patients who are candidates for a cardiac transplant.

"We have observed a marked increase in thoracotomy interest in the U.S. and internationally, with more than 20 percent of global HVAD implants in the past year performed via this less-invasive method," HeartWare CEO Doug Godshall said in a statement. "We are encouraged that physicians are able to take advantage of the versatility of the HVAD Pump and look forward to confirming the potential benefits of the thoracotomy implant technique previously published through single-center studies in the U.S. and Europe."

HeartWare could use some good news from the trial after a difficult 2014. Over the summer the FDA issued a formal warning regarding the device. The agency gave the company one month to correct software and manufacturing issues tied to the system that were uncovered by an inspection of its Miami Lakes, FL facility.

- read the release

Suggested Articles

The ADDF announced its second round of research awards, with a total of $6 million in new funding for diagnostic tests.

Takeda teamed up with Enzyre to develop an at-home diagnostic device that will help people with hemophilia determine their own coagulation status.

Foundation Medicine received a diagnostic approval from the FDA for selecting HR+/HER2- breast cancer patients for treatment with Novartis' Piqray.