A medical device company secured an ISO Certification and CE Mark approval for a stapling device to improve angioplasty results for peripheral artery disease.
The Tack-It Endovascular Stapler device consists of a catheter with four self-expanding tacks. The 6 mm-length implant has six pairs of anchors to optimize angioplasty by fitting together tissue to smooth the arterial lumen. The device is produced by InTact Vascular in Wayne, Pennsylvania.
Carol A. Burns, the CEO, said the CE Mark was a significant milestone for the company.
“We are one step closer to providing this technology for patients in which peripheral artery disease procedures are growing at double-digit rates partly due to the staggering rise in patients with type 2 diabetes,” she said. “This is a unique solution for patients, offering physicians a new paradigm for treatment.”
In February, the company said it had raised $2.5 million since September to fund clinical trials for the implanted device in Europe.
Co-founder and chief medical officer Dr. Peter Schneider said in a company statement: “Right now, we are very limited by the tools we have available. We can either do angioplasty, which often produces a suboptimal result, or we can place a stent, which looks good initially but often does not last and has a lot of downstream problems. We believe the Tack-It technology will offer a new solution to address this problem. One of the key design features is that the device can treat a range of diameters offering tremendous versatility. This will enable physicians to go down the leg after angioplasty and spot-treat several areas using a single device.”
A clinical trial on 11 patients was done in South America in whom 50 tacks were placed. The subjects were tracked for 12 months, according to the statement.
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.
Peripheral artery disease affects more than 8 million people each year, with about one-fifth of patients requiring treatment.
