The SinuSys Vent-Os Sinus Dilation System recently received clearance from the Food and Drug Administration.
The system is a two-step interventional procedure designed to resolve sinusitis symptoms. Here, SinuSys CEO Thomas Schreck discusses the system and where this technology is headed in the future.
Q: How is the Vent-Os Sinus Dilation System different from other products on the market?
Thomas Schreck: We have designed the Vent-Os System to be more tolerable for patients and much simpler to perform than either balloon sinuplasty or surgery, making it ideal for an outpatient or office setting using only local anesthesia. Unlike balloon dilation devices that use rapid, high-pressure inflation (~180 psi), the Vent-Os Sinus Dilation System is a small, low-pressure (~40 psi), self-expanding insert designed to gently and gradually open the maxillary ostia. Because of the simplicity of the device, virtually any physician can perform the procedure.
Q: What are the benefits for patients and surgeons of using the Vent-Os?
TS: The Vent-Os System is designed to be a gentler and better tolerated solution to resolve a patient's painful chronic sinusitis symptoms. As an outpatient or office procedure, it is convenient for the patient, and requires only a pre-procedural local anesthetic. This is in contrast to balloon dilation devices, which often require administration of anxiolytics, analgesics and/or additional local injections of anesthetics during the procedure to increase patient tolerability. And our clinical study is demonstrating that it has long-lasting effects, as the sinus ostia stay patent over time.
The procedure is designed to be a simple, two-step procedure for physicians, as opposed to the complexity of balloon dilation. No interventional skills or special training are required as the device is intuitive to use.
Q: What impact do you think it will make on the clinical and operational environment of the outpatient centers that incorporate the Vent-Os?
TS: As the Vent-Os System is used in a simple, two-step procedure, it is much quicker than balloon sinuplasty, which may create efficiencies for outpatient centers and individual physical practices. Because of the improved tolerability of the procedure, more patients may seek treatment for their chronic sinusitis. The gentleness and ease of the procedure may also allow physicians to treat sinusitis earlier in the disease progression.
Q: What does it take for physicians and staff to train on utilization?
TS: Virtually any physician can perform the Vent-Os procedure. The simple, two-step procedure is similar to existing in-office diagnostic and interventional procedures, so physician and staff training is minimal.
Q: Where do you see this type of technology heading in the future? What is the next generation or best opportunity for continued development?
TS: We see the Vent-Os procedure achieving strong adoption in outpatient centers and physician offices as it is so simple, efficient and well tolerated. Our current technology is designed for the maxillary sinus, which is involved in the majority (~70 percent) of sinusitis cases. Based on the clinical success we are seeing with this device, we are developing the same osmotic technology to be used in other sinus anatomy.
More Articles on Surgery Centers:
ASC QI Projects: Best Ideas for Biggest Impact
24 Statistics on Surgery Staff & Wages Based on Number of ORs
Eliminate the Weak Links in Supply Chain: 4 Core Points
The system is a two-step interventional procedure designed to resolve sinusitis symptoms. Here, SinuSys CEO Thomas Schreck discusses the system and where this technology is headed in the future.
Q: How is the Vent-Os Sinus Dilation System different from other products on the market?
Thomas Schreck: We have designed the Vent-Os System to be more tolerable for patients and much simpler to perform than either balloon sinuplasty or surgery, making it ideal for an outpatient or office setting using only local anesthesia. Unlike balloon dilation devices that use rapid, high-pressure inflation (~180 psi), the Vent-Os Sinus Dilation System is a small, low-pressure (~40 psi), self-expanding insert designed to gently and gradually open the maxillary ostia. Because of the simplicity of the device, virtually any physician can perform the procedure.
Q: What are the benefits for patients and surgeons of using the Vent-Os?
TS: The Vent-Os System is designed to be a gentler and better tolerated solution to resolve a patient's painful chronic sinusitis symptoms. As an outpatient or office procedure, it is convenient for the patient, and requires only a pre-procedural local anesthetic. This is in contrast to balloon dilation devices, which often require administration of anxiolytics, analgesics and/or additional local injections of anesthetics during the procedure to increase patient tolerability. And our clinical study is demonstrating that it has long-lasting effects, as the sinus ostia stay patent over time.
The procedure is designed to be a simple, two-step procedure for physicians, as opposed to the complexity of balloon dilation. No interventional skills or special training are required as the device is intuitive to use.
Q: What impact do you think it will make on the clinical and operational environment of the outpatient centers that incorporate the Vent-Os?
TS: As the Vent-Os System is used in a simple, two-step procedure, it is much quicker than balloon sinuplasty, which may create efficiencies for outpatient centers and individual physical practices. Because of the improved tolerability of the procedure, more patients may seek treatment for their chronic sinusitis. The gentleness and ease of the procedure may also allow physicians to treat sinusitis earlier in the disease progression.
Q: What does it take for physicians and staff to train on utilization?
TS: Virtually any physician can perform the Vent-Os procedure. The simple, two-step procedure is similar to existing in-office diagnostic and interventional procedures, so physician and staff training is minimal.
Q: Where do you see this type of technology heading in the future? What is the next generation or best opportunity for continued development?
TS: We see the Vent-Os procedure achieving strong adoption in outpatient centers and physician offices as it is so simple, efficient and well tolerated. Our current technology is designed for the maxillary sinus, which is involved in the majority (~70 percent) of sinusitis cases. Based on the clinical success we are seeing with this device, we are developing the same osmotic technology to be used in other sinus anatomy.
More Articles on Surgery Centers:
ASC QI Projects: Best Ideas for Biggest Impact
24 Statistics on Surgery Staff & Wages Based on Number of ORs
Eliminate the Weak Links in Supply Chain: 4 Core Points