Michael Barbella, Managing Editor01.21.23
Studies and product sanctions took top billing this past week on MPO's website.
Data from two Medtronic trials drove the majority of online traffic. Study results support the clinical efficacy of the company's cardiovascular technology.
One trial demonstrated that early intervention with Medtronic's Arctic Front Cryoablation Catheters was more effective than antiarrhythmic drugs (AADs) in preventing atrial arrhythmia recurrence and reducing atrial fibrillation (AFib) disease progression rates as a first-line therapy. Compared to AAD therapy, patients treated with the Medtronic cryoablation therapy achieved a 75% relative reduction in the rate of disease progression from paroxysmal to persistent AFib, 36-month study results showed. In addition, 42.7% of patients in the cryoballoon group achieved freedom from atrial tachyarrhythmia recurrence at 36 months compared to 9.3% in the AAD group.
Six-month results from the company's SPYRAL HTN-ON MED clinical trial are equally as encouraging. Subjects who were prescribed antihypertensive medications and were treated with the Medtronic Symplicity Spyral Renal Denervation (RDN) System had a statistically significant and clinically meaningful reduction in office-based systolic blood pressure (OSBP), a key secondary endpoint, compared with subjects in a sham control group. However, in the primary endpoint, RDN did not demonstrate a statistically significant reduction in 24-hour ambulatory systolic blood pressure (ABPM) due to increased medications in the sham control group and the potential impacts of the COVID-19 pandemic on the clinical trial environment.
In addition to the studies, site visits benefitted from Shockwave Medical's most recent acquisition (Neovasc) and regulatory approvals for both Pentax Medical and Abbott. Hoya Corp. division Pentax Medical gained CE marks for its INSPIRA video processor and i20c video endoscope series, while Abbott Labs received FDA approval for its latest-generation transcatheter aortic valve implantation (TAVI) system, Navitor, to treat patients with severe aortic stenosis at high or extreme risk for open-heart surgery.
Data from two Medtronic trials drove the majority of online traffic. Study results support the clinical efficacy of the company's cardiovascular technology.
One trial demonstrated that early intervention with Medtronic's Arctic Front Cryoablation Catheters was more effective than antiarrhythmic drugs (AADs) in preventing atrial arrhythmia recurrence and reducing atrial fibrillation (AFib) disease progression rates as a first-line therapy. Compared to AAD therapy, patients treated with the Medtronic cryoablation therapy achieved a 75% relative reduction in the rate of disease progression from paroxysmal to persistent AFib, 36-month study results showed. In addition, 42.7% of patients in the cryoballoon group achieved freedom from atrial tachyarrhythmia recurrence at 36 months compared to 9.3% in the AAD group.
Six-month results from the company's SPYRAL HTN-ON MED clinical trial are equally as encouraging. Subjects who were prescribed antihypertensive medications and were treated with the Medtronic Symplicity Spyral Renal Denervation (RDN) System had a statistically significant and clinically meaningful reduction in office-based systolic blood pressure (OSBP), a key secondary endpoint, compared with subjects in a sham control group. However, in the primary endpoint, RDN did not demonstrate a statistically significant reduction in 24-hour ambulatory systolic blood pressure (ABPM) due to increased medications in the sham control group and the potential impacts of the COVID-19 pandemic on the clinical trial environment.
In addition to the studies, site visits benefitted from Shockwave Medical's most recent acquisition (Neovasc) and regulatory approvals for both Pentax Medical and Abbott. Hoya Corp. division Pentax Medical gained CE marks for its INSPIRA video processor and i20c video endoscope series, while Abbott Labs received FDA approval for its latest-generation transcatheter aortic valve implantation (TAVI) system, Navitor, to treat patients with severe aortic stenosis at high or extreme risk for open-heart surgery.