Maquet Cardiovascular landed FDA 510(k) clearance and CE Mark approval in the European Union for a new version of its intra-aortic balloon catheters, the Sensation Plus 7.5Fr 40cc.
The larger-volume fiber optic IAB catheter, designed for smaller patients between 5’0" and 5’4", will be on the market in the U.S. and E.U. in October, according to a press release.
That’s the latest in a series of wins for Wayne, N.J.-based Maquet. The company in June won CE Mark approval for its Intergard Synergy vascular graft, which is made with anti-microbial compounds to prevent vascular graft infections.
In May Maquet won 510(k) for new sizes of its Mega intra-aortic balloon catheters.
"Over the last 12 months, Maquet has launched 2 new families of IAB catheters, as well as a new balloon pump, Cardiosave – all of which are designed to revolutionize counterpulsation therapy, from both an efficacy and safety perspective," president & CEO Christian Keller said in prepared remarks. "As a global leader in hemodynamic support, we are dedicated to developing and marketing new and innovative products that continuously improve the therapy needs of hemodynamically compromised patients thereby improving patient outcomes."
Maquet has, however, seen some bad luck in recent months. Results from the Maquet-sponsored IABP-Shock II trial found no benefit for intra-aortic balloon pump therapy in MI patients, calling into question a practice used for decades with one of the oldest medical devices.
Despite wide use and clinical acceptance, the procedure failed to produce only minimal clinical benefit in the 600-patient IABP-Shock study, the largest trial ever performed in cardiogenic shock.
Trial sponsor Maquet tried to look on the brighter side of the study results. The study did find a mild 30-day benefit among IABP patients, even though it did not meet the 12% improvement mark researchers were aiming for, the company noted at the time.
Although the trial didn’t achieve a statistically significant difference in 30-day mortality between the IABP and control arms, a difference was beginning to emerge at the 20-30 day mark, Maquet noted. After 30 days the mortality rate in the IABP arm was 39.7%, compared with 41.3% in the control group.