FDA News

FDA approves stent system for acute coronary artery perforations

Dean J. Kereiakes, MD, FACC, FSCAI
Dean J. Kereiakes

The FDA announced it has approved a coronary stent system for the treatment of patients with acute coronary artery perforations occurring during PCI.

The stent system (PK Papyrus Covered Coronary Stent System, Biotronik) is the first device in 17 years that has been approved by the FDA for this indication, according to a press release from the agency.

“This is a limited-use, but very important application,” Dean J. Kereiakes, MD, FACC, FSCAI, medical director of The Christ Hospital Heart and Vascular Center in Cincinnati, medical director of the Carl and Edyth Lindner Center for Research and Education at The Christ Hospital and professor of clinical medicine at Ohio State University, told Cardiology Today’s Intervention. “I’ve been doing this for years. We used the first Jostent (JOMED), a precursor for this. Before that, we did things like … take a piece of saphenous vein from a patient on the cath table and sew it onto a Palmaz-Schatz stent to go in and seal a perforation.”

The stent system is a balloon-expandable covered coronary stent and delivery system that is inserted into the perforated coronary artery vessel with a balloon catheter. Once implanted, the system creates a physical barrier that seals the tear while allowing blood to flow to the heart muscle, according to the release.

“An acute coronary artery perforation is a rare, but potentially life-threatening complication of heart vessel procedures,” Bram Zuckerman, MD, director of the division of cardiovascular devices in the Center for Devices and Radiological Health for the FDA, said in the press release. “The PK Papyrus Covered Coronary Stent System provides health care providers with a new treatment option that can seal the perforation in order to stop blood leakage during the procedure and avoid a potentially life-threatening complication or a more invasive surgical procedure.”

The FDA stated it reviewed real-world survey data, which included information from 80 patients who received the stent for the treatment of coronary artery perforations. Successful delivery occurred in 95% of patients, and the perforation was successfully sealed in 91.3% of patients, according to the release. Death occurred in two patients during PCI, and seven patients had fluid drained from around the heart. Five patients whose perforations were successfully sealed with the system died post-procedure in the hospital, and one patient died during this time whose perforation was not successfully sealed.

Contraindications for the stent device include patients who are not candidates for PCI, such as those who are unable to take anticoagulation and/or antiplatelet therapy, those with uncorrected bleeding disorders and those with allergies to contrast media. Other contraindications include patients with a known hypersensitivity or allergy to amorphous silicon carbide or another compound of the stent system, including cobalt chromium alloy, L-605 and Siloxane-based Polyurethane.

“In that [high-risk] environment, it’s even more essential for every lab, particularly that’s doing that level of work, to have this type of a device on the shelf because you never know when you’re going to need it, and when you need it, you need it right away,” Kereiakes, a member of the Cardiology Today’s Intervention Editorial Board, said in an interview. “Fortunately, it’s a significant technological advance over anything else that can be used for the same purpose.”

For more information:

Dean J. Kereiakes, MD, FACC, FSCAI, can be reached at The Christ Hospital Medical Office Building, 2123 Auburn Ave., Suite 136, Cincinnati, OH 45219.

Disclosures: Kereiakes reports he is a consultant for Abbott, Boston Scientific, Micell, Sinomed and Svelte Medical. Zuckerman is an employee of the FDA.

Dean J. Kereiakes, MD, FACC, FSCAI
Dean J. Kereiakes

The FDA announced it has approved a coronary stent system for the treatment of patients with acute coronary artery perforations occurring during PCI.

The stent system (PK Papyrus Covered Coronary Stent System, Biotronik) is the first device in 17 years that has been approved by the FDA for this indication, according to a press release from the agency.

“This is a limited-use, but very important application,” Dean J. Kereiakes, MD, FACC, FSCAI, medical director of The Christ Hospital Heart and Vascular Center in Cincinnati, medical director of the Carl and Edyth Lindner Center for Research and Education at The Christ Hospital and professor of clinical medicine at Ohio State University, told Cardiology Today’s Intervention. “I’ve been doing this for years. We used the first Jostent (JOMED), a precursor for this. Before that, we did things like … take a piece of saphenous vein from a patient on the cath table and sew it onto a Palmaz-Schatz stent to go in and seal a perforation.”

The stent system is a balloon-expandable covered coronary stent and delivery system that is inserted into the perforated coronary artery vessel with a balloon catheter. Once implanted, the system creates a physical barrier that seals the tear while allowing blood to flow to the heart muscle, according to the release.

“An acute coronary artery perforation is a rare, but potentially life-threatening complication of heart vessel procedures,” Bram Zuckerman, MD, director of the division of cardiovascular devices in the Center for Devices and Radiological Health for the FDA, said in the press release. “The PK Papyrus Covered Coronary Stent System provides health care providers with a new treatment option that can seal the perforation in order to stop blood leakage during the procedure and avoid a potentially life-threatening complication or a more invasive surgical procedure.”

The FDA stated it reviewed real-world survey data, which included information from 80 patients who received the stent for the treatment of coronary artery perforations. Successful delivery occurred in 95% of patients, and the perforation was successfully sealed in 91.3% of patients, according to the release. Death occurred in two patients during PCI, and seven patients had fluid drained from around the heart. Five patients whose perforations were successfully sealed with the system died post-procedure in the hospital, and one patient died during this time whose perforation was not successfully sealed.

Contraindications for the stent device include patients who are not candidates for PCI, such as those who are unable to take anticoagulation and/or antiplatelet therapy, those with uncorrected bleeding disorders and those with allergies to contrast media. Other contraindications include patients with a known hypersensitivity or allergy to amorphous silicon carbide or another compound of the stent system, including cobalt chromium alloy, L-605 and Siloxane-based Polyurethane.

“In that [high-risk] environment, it’s even more essential for every lab, particularly that’s doing that level of work, to have this type of a device on the shelf because you never know when you’re going to need it, and when you need it, you need it right away,” Kereiakes, a member of the Cardiology Today’s Intervention Editorial Board, said in an interview. “Fortunately, it’s a significant technological advance over anything else that can be used for the same purpose.”

For more information:

Dean J. Kereiakes, MD, FACC, FSCAI, can be reached at The Christ Hospital Medical Office Building, 2123 Auburn Ave., Suite 136, Cincinnati, OH 45219.

Disclosures: Kereiakes reports he is a consultant for Abbott, Boston Scientific, Micell, Sinomed and Svelte Medical. Zuckerman is an employee of the FDA.