Showing posts with label absorbable implant. Show all posts
Showing posts with label absorbable implant. Show all posts

06 July, 2016

FDA approves Abbott's fully dissolving heart stent

Abbott announced that the U.S. Food and Drug Administration has approved the company's Absorb bioresorbable heart stent, making the first-of-its-kind medical device commercially available to treat people with coronary artery disease in the United States.



Absorb is the only fully dissolving stent approved for the treatment of coronary artery disease, which affects 15 million people in the United States and remains a leading cause of death worldwide, despite decades of therapeutic advances. While stents are traditionally made of metal, Abbott's Absorb stent is made of a naturally dissolving material, similar to dissolving sutures. Absorb disappears completely1 in approximately three years, after it has done its job of keeping a clogged artery open and promoting healing of the treated artery segment. By contrast, metal stents are permanent implants that restrict vessel motion for the life of the person treated.

"The Absorb bioresorbable scaffold represents a major advance in the treatment of coronary artery disease," said Gregg W. Stone, M.D., FACC, FSCAI, director, cardiovascular research and education, Center for Interventional Vascular Therapy, Columbia University Medical Center, New York-Presbyterian Hospital and the chairman of the ABSORB clinical trial program. "This novel technology appeals to both physicians and patients alike because after treating the underlying blockage it is completely absorbed, leaving nothing behind. No metal means the treated artery can pulse and flex naturally as demands on the heart change with everyday activities. No metal may also reduce the potential of future blockages that occur with permanent metallic stents, and allows easier access to other treatment options should they prove necessary in the patient's future."

Abbott plans to offer the Absorb device to hospitals in the United States, starting with interventional cardiology centers that participated in Absorb clinical trials.

"Abbott's goal is to help people everywhere live better, fuller and healthier lives," said Deepak Nath, Ph.D., senior vice president, vascular, Abbott. "The Absorb bioresorbable stent treats coronary artery disease without committing people to a permanent metal implant—giving them peace of mind and helping them get back to their daily lives without the concern of having a permanent metallic implant. We're very excited to bring the promise of Absorb to patients in the United States."

In clinical studies conducted around the world, the Absorb bioresorbable stent demonstrated comparable short-term and mid-term outcomes to the leading metallic stent—Abbott's Xience™ drug eluting stent. At one year in a pre-specified group of approximately 2,000 U.S. patients in the pivotal ABSORB III randomized clinical trial, patients who received the dissolving Absorb stent experienced comparable rates of specific adverse events in the intended patient population (reference vessel diameter of ≥ 2.5 mm and ≤ 3.75 mm)—including heart disease-related death, heart attacks attributed to the stented artery and repeat procedures at the treated lesion (collectively termed target lesion failure)—as compared to patients who received the metallic Xience stent.

Abbott's Absorb stent, sold commercially as the Absorb GT1 Bioresorbable Vascular Scaffold (BVS) system, is now available in more than 100 countries, including the United States, and has been used to treat more than 150,0002 people with coronary artery disease worldwide.

A press release can be found from Abbott website.

30 June, 2016

Nerve Capping Device for Treatment and Prevention of Symptomatic Neuroma CE Marked

Polyganics, a privately held medical technology company, announced that it has received the CE mark for NEUROCAP®, its nerve capping device. Polyganics intends to launch NEUROCAP® in several European countries later this year.

NEUROCAP® is an absorbable implant for the treatment and reduction of symptomatic neuroma in peripheral nerves. The device was cleared for sales in the United States in January 2016, and Polyganics introduced NEUROCAP® during the Annual Meeting of the American Society of Surgery of the Hand in Phoenix last January.

In February, the European STOP NEUROMA study started to gather evidence for the long-term effectiveness of NEUROCAP® in the reduction of painful neuroma formation. The first patients have been successfully enrolled at the MC Groep hospital in Emmeloord, The Netherlands, by Coordinating Investigator MariĆ«tta Bertleff, MD. Through this study, Polyganics is collecting more data on the clinical performance of NEUROCAP®’s ability to isolate the nerve end, and the product’s effectiveness with respect to the reduction of pain from the symptomatic neuroma and prevention of pain reoccurrence.

Rudy Mareel, CEO of Polyganics said, “CE regulatory approval is a key milestone for our nerve capping device. We strongly believe NEUROCAP® represents an important addition to the surgeons’ tool-box in the treatment of peripheral nerve injuries enhancing surgical outcomes and patient recovery.

Furthermore, if NEUROCAP® shows effectiveness in terms of preventing pain symptoms to return over a one-year period, the device could be used in the prevention of painful neuroma formation following amputations. This is an additional, even more significant population which is steadily increasing due to the growing prevalence of diseases such as diabetes.”

More information can be found from Polyganics website.