Medtronic has received FDA regulatory approval to market a pair of left ventricle cardiac resynchronization leads. The Attain Ability Plus and Attain Ability Straight left-heart leads are designed for better retention and easier placement.
From a Medtronic press release:
A pooled data analysis from several Medtronic left-heart lead studies for 1,307 patients presented today at Heart Rhythm 2011, the Heart Rhythm Society’s 32nd Annual Scientific Sessions, shows a CRT retention rate of 95 percent at 18 months for Medtronic’s Attain family of left heart leads. In this analysis, CRT retention rate was defined as 18-month survival rate from loss of CRT due to any left ventricle (LV) lead-related events that required operative intervention or termination of CRT. The observed events were LV lead dislodgement, phrenic nerve stimulation (PNS) (electrical stimulation of the nerve that facilitates breathing), and other LV lead failures such as elevated thresholds, loss of capture and lead fracture. Clinically acceptable performance was achieved in the majority of patients in this analysis using a variety of Medtronic left-ventricle leads to accommodate varying anatomies.
Attain Ability Plus enables physicians to reach and maintain the target vein, providing stability in medium-to-large venous anatomies, while Attain Ability Straight allows physicians to maneuver through small cardiac veins. These leads are part of the only portfolio of medical technology to incorporate NASA-developed insulation material that was previously evaluated for space applications, high-performance engines and harsh environments.
The design of the Attain Ability Plus and Attain Ability Straight left-heart leads, combined with their capacity to be delivered via the Attain Select II, a sub-selection catheter (in leads ³ 88 cm in length), assists physicians in placing the lead directly in difficult to reach locations in the heart.
According to clinical studies conducted on these leads, approximately 94 percent of physicians positively rated the ability to position the Attain Ability Plus lead to the desired cardiac veins, with a one-month complication-free rate of 98.5 percent. Additionally, 96.8 percent of physicians positively rated the handling of the Attain Ability Straight and the ability to maneuver it to the appropriate veins, with a low lead-dislodgement rate of 3.2 percent. Both left-heart leads offer multiple pacing vectors, which may help address PNS and help prevent the need to reposition the lead invasively.