A medical device company with a combination catheter-stapler device to improve outcomes in balloon angioplasty procedures to treat peripheral artery disease has raised $11 million. The funding comes after the company secured CE Mark approval in Europe for its device earlier this year.
Intact Vascular‘s Tack It Endoscopy Stapler System is a permanent implant that uses four self-expanding tacks and six pairs of anchors to create tissue apposition along the walls of the artery and smooth the arterial lumen to improve blood flow. It is designed to overcome potential complications for angioplasty procedures like irregularly shaped lumen and tissue dissection that can lead to acute or long-term complications resulting in tissue loss or amputation. The device was designed by Robert Giasolli, a co-founder and the company’s chief technology officer and vice president of research and development.
Carol Burns, the co-founder and CEO of the Wayne, Pennsylvania-based company, said its system produces “less foreign material in the artery, less long-term chronic injury to the vessel and the ability to perform ‘spot’ treatment to the vessel only where needed,” according to its website.
Burns told MedCity News earlier this year that in addition to seeking CE Mark approval, it planned to conduct two clinical trials over the next 18 months and then would embark on clinical trials to seek approval from U.S. regulators.
Peripheral artery disease is a blockage in peripheral blood vessels that carry blood to the heart by fatty plaque, a condition that can be caused by atherosclerosis. It can occur in the arms and legs, but is more common in the legs. About 8 million people in the U.S. have the disease, according to the Centers for Disease Control and Prevention’s website.
Other companies have also devoted attention to the problem of peripheral artery disease, although many are in the early or preclinical stages.
A Deep-dive Into Specialty Pharma
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
Nanoparticles: Vascular Magnetics developed a drug-delivery system involving magnetically guided nanoparticles that deliver drugs to the affected blood vessels using paclitaxel, an antirestenosis drug. The treatment is based on research by Vascular Magnetics co-founder Dr. Robert J. Levy, who holds the William J. Rashkind Endowed Chair of pediatric cardiology at Children’s Hospital of Philadelphia and is the director of the hospital’s cardiac research laboratory.
Ultrasound: International Cardio Corp. licensed High Intensity Focused Ultrasoundtechnology from the University of Minnesota in a noninvasive treatment approach to the disease. The technology adapts ultrasound imaging technology to generate heat. The heat can be applied directly to the blood in the capillary that feeds the plaque. The technology was developed by Emad Ebbinni, a professor in the University of Minnesota’s electrical and computer engineering department.
Drug-coated balloon catheter: Lutonix developed a drug-coated percutaneous transluminal angioplasty balloon called Moxy. The balloon is used to deliver the drug paclitaxel into arterial walls and clear blockages in patients. The treatment spurred the Minnesota company’s $225 million acquisition by New Jersey-based C.R. Bard last year. Medtronic has also been active in the drug-coated balloon technology space, having launched a clinical trial earlier this year.
