FDA-approved device, an alternative to traditional stents, can save patients from lower-limb amputations and decrease risk of a heart-related incident

St. Elizabeth’s Medical Center, part of Steward Health Care and a teaching hospital of Tufts University School of Medicine, this week became the first hospital in New England to use the Lutonix 035 Drug Coated Balloon PTA Catheter, a new device to treat patients with peripheral artery disease. The device will offer patients the ability to undergo endovascular procedures to treat peripheral vascular disease that “leave nothing behind” and offers new hope for patients who suffer from symptomatic peripheral vascular disease or are at risk for lower extremity amputations.

“This is a huge step forward in the treatment of peripheral artery disease,” said Dr. Lawrence Garcia, chief of Interventional Cardiology at St. Elizabeth’s, who performed the first procedure in New England on Tuesday using the new device. While this device has been available overseas for several years, the Food and Drug Administration on Sunday approved it for commercial use in the United States, he said.

Garcia’s patient is recovering well at St. Elizabeth’s Medical Center, located at 736 Cambridge St., Brighton, and is expected to enjoy a higher quality of life as a result of undergoing this procedure with the new drug coated balloon. The new treatment is also expected to reduce the recurrence of the patient’s disease due to restenosis.

“It will improve his ability to ambulate without limitation,” Garcia said. “It’s really about our pateints’ quality of life.”

Peripheral Arterial Disease (PAD) in the femoropopliteal (thigh) artery, a lifestyle limiting condition, that affects millions of Americans by narrowing arteries and reducing blood flow to the limbs, according to American Heart Association (AHA) estimates. Patients with PAD in the femoropopliteal arteries are at risk for lower-extremity amputation, particularly in people over the age of 50. Minimally-invasive endovascular procedures such as angioplasty balloons and stents, medications and vascular bypass surgery are some of the accepted ways to treat PAD, but these options may be limited depending on the type of arterial blockage.

Successful treatment of PAD requires improved blood flow (patency) for longer periods of time. A recent clinical study demonstrated superior primary patency with the LUTONIX ® 035 DCB for the efficacy endpoint.

Prior to the approval of the new drug coated balloon, patients had been treated, in some cases, with bare metal stents as well as with drug coated stents or other devices such as atherectomy (devices that remove plaque to re-establish blood flow, all of which have not always been successful in the treatment for our patients, Garcia said.

“We are committed to bringing innovations in care to our patients and we are excited to be the first hospital in New England to offer this new treatment option to our patients,” said Garcia. “The LUTONIX ® 035 DCB is a new first-line therapy for treating blockages without closing the door to other treatment options down the road, an important consideration as we help our patients manage this painful, progressive and debilitating disease.”

About St. Elizabeth’s Medical Center
St. Elizabeth’s Medical Center is a major academic medical center affiliated with Tufts University School of Medicine. Areas of medical excellence include vascular and endovascular surgery, cardiology, neurosciences, general and robotic surgery, bariatric surgery, women’s health, high-risk obstetrics, bone and joint health, hematology/oncology, pulmonary medicine and emergency medicine. St. Elizabeth’s is a member of Steward Health Care, which is the second largest health care system in New England. Visit St. Elizabeth’s online at semc.org

Why PAD Matters – American Heart Association Web site. Available at: http://www.heart.org/HEARTORG/Conditions/More/PeripheralArteryDisease/Why-PAD-Matters_UCM_301303_Article.jsp.
2 Peripheral Arterial Disease – NIH National Heart, Lung, and Blood Institute. Available at: https://www.nhlbi.nih.gov/health/health-topics/topics/pad.