On April 10, Biotronik announced the US launch of its PK Papyrus covered coronary stent system, following its FDA approval in September 2018. The stent is used to treat emergency acute coronary artery perforations,
GlobalData estimates that in the US, less than 1% of all percutaneous coronary stenting procedures use covered stents due to the rare nature of acute coronary artery perforation. However, despite the fact that acute coronary artery perforations are uncommon, they are a potentially life-threatening complication to procedures performed in heart vessels. Covered stents allow physicians to utilize a minimally invasive approach to sealing perforations after percutaneous coronary interventions (PCI) and avoid more invasive interventions. GlobalData expects that while covered stents will still represent less than 1% of all coronary stenting procedures, the number of covered stents is expected to grow alongside the overall PCI market at a Compound Annual Growth Rate (CAGR) of 2.5% by 2028.
PK Papyrus was the first device approved for acute coronary artery perforations in almost two decades and was granted approval as a humanitarian device exemption (HDE). HDE-designated devices are intended to benefit patients with a condition that affects less than 8,000 Americans per year. Prior to Biotronik’s entrance into the market, Abbott Laboratories’ Jostent had monopolized the US covered stent market since its FDA approval through the HDE process in 2001.
GlobalData predicts that Biotronik may face difficulty in gaining market share within a small and specialized market, particularly against Abbott Laboratories, which has a much larger product portfolio and a well-established presence in the market. However, if PK Papyrus proves to have better outcomes than Abbott’s Jostent due to being a newer device and the advancements in technology, Biotronik may overcome some of these challenges and gain a portion of the market share.