Biotronik’s PK Papyrus might be paper thin – but the coronary stent system is extremely sturdy. The Lake Oswego, OR-based company recently announced it was launching the technology in the U.S. The paper-thin stent is one of the key devices in helping Biotronik launch its coronary vascular intervention (CVI) business.
“PK Papyrus is still durable and I think that’s the key component,” Amy Culley, director of Vascular Intervention Clinical Studies, for Biotronik Inc., told MD+DI. “It might look like paper but it’s still a very strong polyurethane membrane [device] that will seal the [coronary artery perforation].”
The ultrathin strut, single-stent design and electrospun polyurethane membrane expands treatment options and is designed to reduce the high rate of adverse outcomes associated with coronary artery perforations.
The technology is available in 17 sizes and Biotronik said the device is the only 5 French compatible covered coronary stent on the U.S. market. Biotronik also said its covered stent is 58% more flexible, and has a 23% smaller crossing profile compared to Abbott Laboratories’ Graftmaster, which has a layered dual-stent design and is the only other covered coronary stent available in the U.S.
"Clinicians can now rely on a low-profile covered stent during critical cardiac emergencies. In situations where every second counts, physicians can trust PK Papyrus to deliver quickly,” Ryan Walters, President of Biotronik Inc., said in a release. “Biotronik's covered stent is designed to save more lives and to help avoid emergency bypass surgeries, which come with increased risk for patients and can be costly for hospitals. This is innovation that matters for hospital administrators, physicians and their patients, who deserve the best outcomes."
PK Papyrus’ launch comes about seven months after Biotronik won a nod from FDA for the device. The company held off on releasing the product earlier so the launch could coincide with Orsiro’s – a product the firm gained approval for in February. Biotronik has had CE Mark for PK Papyrus since 2013.
“It was important for us to bring this product along with our Orsiro DES onto the [U.S.] market at the same time as we launch our [CVI] business,” Culley told MD+DI. “The timing is more coordinated to ensure that were are providing the complete product line in the CVI portfolio.