Steroid eluting electrodes

About the DANCE Trial:
The Delivery of D examethasone to the A dventitia to e N hance C linical E fficacy after Femoropopliteal Revascularization (DANCE) trial is a perivascular drug delivery trial that pairs the Bullfrog Micro-Infusion Device with dexamethasone to treat femoral and popliteal arteries after revascularization. DANCE is a prospective, multicenter, single-arm study designed and sponsored by Mercator. The trial is being conducted in 35 centers and its leadership includes co-principal investigators Mahmood Razavi, MD, from St. Joseph's Hospital in Orange, California, and George Adams, MD, from the University of North Carolina-Rex Healthcare, in Raleigh, North Carolina. More information about the DANCE trial is available at https:///ct2/show/NCT01983449 .

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We utilize state-of-the art technology, draw from an experienced technical community, and take a creative systematic approach to provide you with a dependable, high-quality and overall cost-effective solution to your manufacturing needs. ProMed has the resources, quality systems and facilities to meet most dimensional and cosmetic print specifications and comply with rigorous industry standards. ProMed has garnered the reputation as the world’s benchmark for molded components and assemblies-and is one of a handful of companies in the world to provide contract manufacturing of drug-eluting products. Facilities are in Minneapolis, MN and Dorado, Puerto Rico with a total of 97,000 square feet of manufacturing space and approximately 200 employees.

Between January 1990 and October 1992, we implanted 16 steroid-eluting ventricular epicardial pacing leads (Medtronic 10295A and 10295B/4965) in 12 patients. There were 8 males and 4 females ranging in age from 3 months to 49 years (mean +/- , median years). Structural cardiac disease was present in 11 of 12 patients. Follow-up ranged from 3-73 months postimplant (mean +/- , median months). Lead fracture (10295A) occurred in 1 of 12 patients. Of the remaining 11 patients, 8 of 11 have very low long-term pacing thresholds. Unexpectedly, 3 patients demonstrated precipitous threshold increases from 3 months to years postimplant. Although no deaths resulted in these exit block patients, 1 of 3 exit block patients developed marked worsening of congestive heart failure. We reviewed and analyzed the data obtained at 4 weeks postimplant for all of the 10295A and 4965 patients in the entire Medtronic clinical study database. Using the criterion of a 4 week postimplant pacing threshold > or = ms (5 V), we found that the long-term risk of eventual exit block was % for the 10295A lead (P = ) and % for the 10295B/4965 lead (P = ). We, therefore, recommend that in patients implanted with the 4965 steroid-eluting epicardial lead, ventricular pacing thresholds > or = ms (5 V) measured at 4 weeks postimplant should prompt frequent threshold testing to detect late and potentially sudden ventricular pacing threshold increases.

Clinical research has shown that resorbable scaffolds, or naturally dissolving stents, offer comparable efficacy and safety profile to drug-eluting stents. Specifically, the Absorb naturally dissolving stent has been investigated in single-arm trials and in randomized trials comparing it to a drug-eluting stent (DES). Early and late major adverse cardiac events, revascularizations, and scaffold thromboses have been uncommon and similar to the Xience DES, a market leader in the drug eluting stent category. [11] [12] [13] [14] [15] Studies in real-world patients are ongoing. [15]

Dr. Groppo has served in various leadership positions at Sacramento area hospitals and physician associations. He is currently the Chief of the Division of Otolaryngology – Head & Neck Surgery at Mercy General Hospital. He is actively involved in planning and reviewing physician continuing medical education for the Dignity Healthcare system and serves as clinical faculty for the Dignity Family Medicine Residency Program. He volunteers his time and expertise by providing charity care for medically indigent patients through the Sierra Sacramento Valley Medical Society SPIRIT program.

Steroid eluting electrodes

steroid eluting electrodes

Between January 1990 and October 1992, we implanted 16 steroid-eluting ventricular epicardial pacing leads (Medtronic 10295A and 10295B/4965) in 12 patients. There were 8 males and 4 females ranging in age from 3 months to 49 years (mean +/- , median years). Structural cardiac disease was present in 11 of 12 patients. Follow-up ranged from 3-73 months postimplant (mean +/- , median months). Lead fracture (10295A) occurred in 1 of 12 patients. Of the remaining 11 patients, 8 of 11 have very low long-term pacing thresholds. Unexpectedly, 3 patients demonstrated precipitous threshold increases from 3 months to years postimplant. Although no deaths resulted in these exit block patients, 1 of 3 exit block patients developed marked worsening of congestive heart failure. We reviewed and analyzed the data obtained at 4 weeks postimplant for all of the 10295A and 4965 patients in the entire Medtronic clinical study database. Using the criterion of a 4 week postimplant pacing threshold > or = ms (5 V), we found that the long-term risk of eventual exit block was % for the 10295A lead (P = ) and % for the 10295B/4965 lead (P = ). We, therefore, recommend that in patients implanted with the 4965 steroid-eluting epicardial lead, ventricular pacing thresholds > or = ms (5 V) measured at 4 weeks postimplant should prompt frequent threshold testing to detect late and potentially sudden ventricular pacing threshold increases.

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