News | Peripheral Artery Disease (PAD) | March 22, 2016

First Pennsylvania Patient Treated in TOBA II Study

PinnacleHealth CardioVascular Institute offers adjunct treatment option for leg artery blockages

PinnacleHealth Cardiovascular Institute, TOBA II study, first patient, Tack Endovascular System, PAD

March 22, 2016 — PinnacleHealth CardioVascular Institute enrolled the first patient in Pennsylvania into the TOBA II clinical on Oct. 19, 2015. This trial is to assess the safety and efficacy of a vascular implant for the treatment of dissections (tearing in the artery wall) that occur following balloon angioplasty (PTA) of the main artery in the leg.

The TOBA II study is designed to enroll 210 subjects at up to 40 sites in the United States and Europe. William Bachinsky, M.D., FACC, medical director of vascular services at PinnacleHealth CardioVascular Institute, serves as principal investigator locally at PinnacleHealth.

The first Pennsylvania patient is from the Harrisburg area and was unable to walk more than a short distance before the procedure without feeling symptoms. All study subjects in TOBA II suffer from advanced peripheral artery disease in one or both legs. They are treated with the Tack Endovascular System following standard balloon angioplasty or drug-coated balloon angioplasty in the superficial femoral and proximal popliteal arteries when a dissection occurs.

The Tack implant supports the specific area of dissection and allows the vessel to heal, while preserving the areas that are open and don’t require additional treatment such as stenting. This “Tacking” approach minimizes the metal left in the artery and the vessel inflammation that can result from traditional stenting.

“We are very excited about having this cutting-edge technology available at PinnacleHealth for patients with claudication — or pain in the legs — due to leg artery blockages,” said Bachinsky. “The Tack implant could be a game-changer by reducing the re-narrowing that can be seen following PTA, allowing for greater flexibility within the artery, and potentially reducing the risk for implant fracture.”

For more information: www.intactvascular.com

Related Content

Medtronic Announces Global Resolute Onyx DES One-Month DAPT Study
News | Antiplatelet and Anticoagulation Therapies| August 18, 2017
Medtronic plc announced a global randomized clinical trial that will evaluate one-month dual antiplatelet therapy (DAPT...
Bivalirudin exhibited an improvement in 30-day all-cause mortality when injected post PCI.
News | Antiplatelet and Anticoagulation Therapies| August 16, 2017
August 16, 2017 — A study has examined the efficacies of various post-percutaneous coronary intervention (PCI) bivali
CMS considers eliminating cardiac bundled payments.
Feature | Business| August 16, 2017 | Dave Fornell
August 16, 2017 — The Centers for Medicare and Medicaid Services (CMS) announced a proposed rule to reduce the number
ESC 2017 late breaking trial hot line study presentations.
News | Clinical Study| August 16, 2017
Aug. 16, 2017 – The European Society of Cardiology (ESC) Congress 2017 includes several Hot Line Late-breaking Clinic
News | Drug-Eluting Balloons| August 15, 2017
Surmodics Inc. announced receipt of an investigational device exemption (IDE) from the U.S. Food and Drug...
The Vascular Dynamics MobiusHD device enhances the carotid baroreceptors to reduce resistant hypertension.
News | Hypertension| August 15, 2017
Aug. 15, 2017 — The U.S. Food and Drug Administration (FDA) has approved the Vascular Dynamics Inc.
Abbott Initiates First Clinical Trial of Clip-Based Tricuspid Repair System
News | Heart Valve Technology| August 09, 2017
Abbott announced that the first patient has been enrolled in a clinical study to evaluate a minimally invasive clip-...
Four Blue Cross Blue Shield Companies Issue Positive Medical Policies on HeartFlow FFRct Analysis
News | FFR Catheters| August 09, 2017
HeartFlow Inc. announced that four Blue Cross Blue Shield companies have each issued a positive medical policy for the...
Overlay Init