Surmodics, Inc. announced that they have received FDA approval for the next generation SurVeil drug-coated balloon for the treatment of peripheral artery disease (PAD).

United States: The US Food and Drug Administration (FDA) on June 20, 2023, approved a medical device SurVeil DCB (drug-coated balloon) which will help physician for percutaneous transluminal angioplasty, after appropriate vessel preparation, of de novo or restenotic lesions (≤ 180 mm in length) in femoral and popliteal arteries with reference vessel diameters of 4 to 7 mm. It had received CE mark certification in the European Union in June 2020. Surmodics specializes in performance coating technologies for intravascular medical devices, as well as chemical and biological coatings for in vitro diagnostic immunoassays and microarrays. Peripheral artery disease is a condition in which the blood vessels that move blood from your heart to your legs become narrowed or blocked. The main cause of peripheral artery disease is atherosclerosis, a condition in which fatty plaque builds up in the arteries. PAD can affect any blood vessel. However, it’s more common in your legs than your arms. Smoking, High blood pressure, Atherosclerosis, Diabetes, High cholesterol, age above 60 years are some of the risk factors for PAD. Symptoms that indicate PAD are weakness, hair loss, pain in legs while doing physical activities like walking, cold or numb toes, and sores in the feet that don’t heal.

PTA, short for Percutaneous Transcutaneous Angioplasty, is a procedure that uses a small flexible plastic tube, also known as a catheter, to open a blocked blood vessel. The tube is attached to a balloon-like device at the end of the catheter. When the balloon is attached to the tube, it expands to widen the blood vessel or artery, allowing normal blood flow to return.

Gary Maharaj, President, and CEO of Surmodics said, “Obtaining FDA approval for our SurVeil DCB is one of the most important achievements in Surmodics’ history, it represents a major milestone in our efforts to develop next-generation products to help millions of people affected by peripheral artery disease and the physicians that treat them. I would like to thank our internal SurVeil DCB team and our external advisors, investigators, and partners for their multi-year efforts to make this achievement possible.”

According to Surmodics, Abbott holds global commercialization rights to the SurVeil DCB. Surmodics manufactures and supplies the product and realizes revenue from product sales for Abbott and a percentage of profits from Abbott's third-party sales for Surmodics. In addition, Surmodics receives a milestone payment of $27 million from Abbott. The commercialization agreement between Surmodics and Abbott was disclosed in February 2018.

Mr. Maharaj Continued and said, “Building on our recent progress, Surmodics remains focused on supporting Abbott and its exclusive worldwide commercialization rights for the SurVeil DCB. We’ll discuss details on the developments and update our fiscal year 2023 financial guidance during our third quarter earnings call.”

As co-principal investigator of TRANSCEND, Dr. Rosenfield presented the TRANSCEND 24-month Follow-up Results at VIVA Foundation VIVA22, which represented the company’s durability of the SurVeil DCB’s safety and efficiency outcomes.

Kenneth Rosenfield, MD, in Surmodics’ commented, market leading that the Surveil DCB will be available to treat patients in the United States, The Surveil DCB is the next-generation DCB as established by results from the TRANSCEND trial, which is the only head-to-head pivotal study that has been conducted versus the market-leading DCB. The Surveil DCB successfully demonstrated noninferior safety and effectiveness at 2 years posttreatment with a substantially lower drug dose.”

According to TechSci Research, the approval of SurVeil DCB covers a therapeutic gap for agitation linked with adults brought on by peripheral artery disease. It is a medical device treatment approved in the U.S. for agitation associated with adults due to peripheral artery disease. With the approval of SurVeil DCB, medical providers  now have a new tool to manage this difficult symptom, potentially enhancing patients' quality of life and lessening the load on caregivers as it includes a special formulation of drug-excipient for a long-lasting balloon coating. For Surmodics, the results of the 24-month clinical trials showed that SurVeil is long-lasting in terms of safety and efficacy. The company also noted that it was not inferior to Medtronic's market-leading In-Pact Admiral. SurVeil has a significantly lower drug dose, according to the company. Also, the key growth strategy combines the company's experience in surface modification and drug delivery coating technologies with the company's design, development, and manufacturing capabilities. The company's mission is to improve disease detection and treatment.