Gradual plaque build-up in coronary arteries tends to limit the oxygen-rich blood supply to your heart muscles and increase the risk of coronary heart diseases, the medical term for tears in the heart's blood vessels. To improve the blood flow in narrowed or blocked arteries, the physicians insert a cardiac stent, which is an expandable coil made of metal mesh, designed to support your artery walls, and keep the artery open. For many people, stenting can enhance the quality of life for patients with heart diseases, and the combination of angioplasty with stenting can be lifesaving, especially when performed right after heart surgery. Stenting is a minimally invasive procedure, that requires only a few days for recovery. In some cases, stenting is an ideal alternative for coronary bypass surgery, an extensive procedure that requires around six weeks or longer to recover. However, the outcome of the stenting procedure may vary from patient to patient, depending on the type of stent used within the arteries. 

Biotronik has recently introduced a new treatment option, PK Papyrus for acute coronary artery perforation. Designed with a high elastic membrane, the medical device is a balloon-expandable covered coronary stent and delivery system that clears clogged blood vessels efficiently. PK Papyrus coronary stent is accessible in 17 broad range of sizes and is the only 5 French compatible covered stent available in the US market. The first FDA-approved 2.5 mm diameter stent for the treatment of acute perforations in nearly two decades, has a low-crossing profile because of its thin membrane and ultrathin strut, and exceptional deliverability, with a 23% reduction in diameter and 58% enhanced flexibility compared to dual-stent design.

The introduction of PK Papyrus signifies a major progression in the domain of interventional cardiology as clinicians can now rely on a low-profile covered stent during cardiac emergencies. In situations where every second matters, physicians can trust PK Papyrus to deliver quickly as it requires a relatively shorter delivery time than most conventional stents available in the market today. Biotronik's covered stent is designed to prevent emergency bypass surgeries, which comes with an increased patient risk and results in high medical costs. The innovation is a major medical breakthrough for the treatment of cardiovascular disorders, designed to overcome the challenges associated with conventional stents.

How does PK Papyrus work?

The PK Papyrus Covered Coronary Stent System is made from cobalt-chromium metal alloy and covered with polyurethane membrane. The stent delivery balloon catheter is well-positioned at the site of a coronary artery perforation, the balloon is inflated, which expands the covered stent and presses it against the coronary artery wall to seal the perforation to allow normal blood flow in the artery. The permanently implanted stent within the coronary artery acts as a physical barrier to prevent bleeding from perforation.

When should not use PK Papyrus?

Although PK Papyrus is a ground-breaking innovation for the treatment of acute coronary disorders, the medical device should not be used if the patients

·         are not able to take antiplatelet agents or undergo anticoagulation therapy

·         have a hypersensitivity to amorphous silicon carbide

·         have lesions that cannot be treated with the system

·         have lesions with abrupt closure during attempted pre-dilation before stent implantation

·         have the risk of blockage of vital coronary artery side from PK Papyrus Covered Coronary Stent

·         Have uncorrected bleeding disorders

·         Have an allergy to contrast media

What makes PK Papyrus distinct from conventional stents?

Annually, 800,000 percutaneous coronary intervention procedures are performed in the United States. In less than one percent of the cases, the coronary artery perforation during the procedure can cause life-threatening internal bleeding that requires immediate treatment, either with a coronary covered stent or emergency coronary artery bypass graft surgery. With covered coronary stents, one can quickly and effectively treat perforations and eliminate the need for coronary artery bypass graft altogether. The covered coronary stent is classified by the FDA as Humanitarian Use Devices since fewer than 8,000 PCIs require treatment of perforation with a stent. For nearly two decades, just one covered stent, the Jostent Graftmaster by Abbott had FDA approval for the treatment of emergency coronary artery perforations. Graftmaster is an expandable polytetrafluoroethylene covered stent, employed for coronary artery perforation and saphenous vein graft lesions. Its dual-stent sandwich design is more rigid and has a larger crossing diameter than standard bare-metal or drug eliciting stent used by physicians in PCI procedures. However, graftmaster is only available in selected sizes, with the potential to treat a limited range of vessel diameters and perforation lengths.

While bare-metal and drug-eluting stent technology continuously evolved, becoming thinner and more agile, covered stent design moved out of the spotlight for nearly 17 years. But with increasingly complex cases associated with cardiovascular disorders, the need for covered single stent design has expanded. The dual-stent design, limited variety of stent lengths and diameters makes the procedure cumbersome for physicians during emergency procedures where every second count. With the single-stent design available, like PK Papyrus to seal perforation, the surgeon takes 47% less time than the average 15 minutes it takes to deliver dual-stent design. The maneuverable PK Papyrus helps physicians in critical care situations to minimize complications for patients and save the time of surgeons.

Design innovations in PK Papyrus have transformed the covered stent from a cumbersome device into a practical and deliverable solution, helping physicians to treat the patients with confidence. The medical device eliminates the need to upsize the radial sheath or gain femoral access, allowing physicians to keep the wire down the vessel, reducing the rate of adverse outcomes, and avoiding costs and risks associated with the emergency surgery.

Complications associated with Stent Implantation

Although major complications are rare, stenting carries all of the same risks as angioplasty such as infection, bleeding, bruising, and severe risks of heart attack, heart stroke, etc. Stenting does not completely eliminate the possibility for a coronary artery to renarrow (occurs in as many as 15-30% of patients) depending on the type of stent. If the restenosis occurs, the patient might require a stenting procedure, bypass surgery, or angioplasty. Although the stents are considered safe and effective, their use may result in stent thrombosis, a blood clot that occurs following implantation of the stent, which may lead to heart attack or even death. However, PK Papyrus stent reduces the risk of stent thrombosis, which is commonly associated with bare-metal or drug-eluting stents.

Conclusion

Stents have been recognized as a powerful medical emergency tool that saves thousands of lives every year worldwide. The probability of survival is at least 30% high in the usage of the stent when compared to other processes like dissolving the clot with thrombolysis, bypass surgery, etc. PK Papyrus is the innovation that matters for hospital administrators, physicians, and patients who deserve better outcomes. With high delivery (98.9%) and sealing success (96.3%), PK Papyrus results in low target lesion revascularization and stent thrombosis rates, which makes it a preferable choice for the treatment of acute coronary perforations.

According to TechSci research report on "Global Stent Market By Type of Product (Vascular Stent (Coronary Vascular Stent, Peripheral Vascular Stent, Neurovascular Stent) and Non-Vascular Stent), By Material (Metallic Biomaterial, Polymeric Biomaterial, and Natural Biomaterials), By Type (Self-Expandable and Balloon-Expandable), By End User (Hospital & Clinics, Ambulatory Care Centres and Others) By Region, Competition, Forecast & Opportunities, 2026", the global stent market is anticipated to witness significant growth and reach a market value of USD25.8 billion by 2026. The growth can be attributed to rising incidences of cardiovascular disorders around the world and the growing adoption of minimally invasive techniques. Moreover, increasing medical advances in the field of interventional cardiology and the introduction of novel technologies are expected to fuel the market growth during the forecast period.

According to another TechSci research report on "Global Cardiac Monitoring & Cardiac Rhythm Management Devices Market By Cardiac Monitoring Devices (ECG Devices, Implantable Loop Recorders, Mobile Cardiac Telemetry Devices, Cardiac Output Monitoring Devices, Others) By Cardiac Rhythm Management Devices (Defibrillators v/s Pacemakers) By End User (Hospitals & Clinics, Cardiac Care Centers, Ambulatory Surgery Centers, Others) By Region, Competition Forecast & Opportunities, 2026", the global cardiac monitoring and cardiac rhythm management devices market is expected to grow at a steady rate through 2026. The growth can be attributed to the surging treatment costs of cardiac diseases and the rising demand for ambulatory and home services. Besides increasing geriatric population and introduction of advanced cardiac management, monitoring, and treatment options for heart arrhythmia are also expected to propel the growth of the global cardiac monitoring and cardiac rhythm management devices market.

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