Medtronic announced data that continues to reinforce the safety, durability, and consistency of the IN.PACT Admiral drug-coated balloon in real-world patients with peripheral arterial disease. Three-year real-world results from the full clinical cohort of the IN.PACT Global Study and one-year data from the Total IN.PACT pooled imaging and propensity analyses were presented at the Cardiovascular and Interventional Radiological Society of Europe annual meeting and the 30th Transcatheter Cardiovascular Therapeutics conference, the annual scientific symposium of the Cardiovascular Research Foundation, respectively. The freedom from clinically-driven target lesion revascularization rate calculated using Kaplan Meier survival estimates was 76.9% in a real-world patient cohort with a mean lesion length of 12.09 +/- 9.54 cm, 18.0% in-stent restenosis, 35.5% occluded lesions, and 39.9% diabetic subjects. Additionally, the proportion of patients undergoing repeat procedures were low through three years. Total IN.PACT combined independently adjudicated data from a total of 1,837 patients treated with IN.PACT Admiral DCB from all IN.PACT Admiral randomized clinical trials and real-world studies from 147 sites across 28 countries. The analyses presented today at TCT specifically looked at two different groups - a core laboratory-adjudicated imaging cohort and a propensity matched imaging cohort. The data showed that IN.PACT Admiral DCB demonstrated consistently superior patency and freedom from clinically-driven target lesion revascularization compared to standard PTA alone. The propensity analysis matched one PTA subject with up to four IN.PACT Admiral DCB subjects based on baseline variables. The propensity-matched analysis showed a patency rate of 90.5% for the IN.PACT Admiral DCB as compared to 53.8% for PTA and a freedom from CD-TLR rate of 96.9% compared to 80.7% for PTA. Additional safety and effectiveness outcomes from the DCB arm also included low rates of thrombosis and CD-TLR, and no occurrences of major target limb amputation at one year.

Investigators unveiled new clinical data from the physician-initiated BIONYX study, representing the first all-comers analysis in nearly 2,500 patients comparing the safety and efficacy of the durable polymer Resolute Onyx drug-eluting stent from Medtronic to the Orsiro biodegradable polymer stent. At one year, the study showed patients with coronary artery disease who were treated with Orsiro BP-DES received no clinical advantage compared to patients treated with the Resolute Onyx DP-DES, and Orsiro BP-DES demonstrated a higher rate of stent thrombosis. Enrolling approximately 2,500 real-world patients, the BIONYX study had a primary composite endpoint of target vessel failure at one-year and showed no statistically significant difference in outcomes for the Resolute Onyx DP-DES treated group at 4.5% compared to 4.7% with the Orsiro BP-DES. However, notable differences were observed in significantly lower rates of definite or probable stent thrombosis at one year. The Resolute Onyx DES is coated with the proprietary BioLinx polymer, a bio-compatible and non-thrombogenic coating specifically designed for use on DES. Low rates of stent thrombosis have been observed in more than 70,000 real-world clinical study patients, with additional studies underway, including the global Medtronic Onyx ONE Month DAPT Program comprised of two studies designed to investigate safety following one-month of dual anti-platelet therapy discontinuation post-PCI. The Resolute Onyx DES offers the broadest size matrix available and is the first-and-only DES to feature Core Wire Technology which enables thinner struts and greater deliverability while maintaining structural strength and enhanced visibility.

Nightstar Therapeutics announced that positive preliminary safety and efficacy data of NSR-RPGR from the dose escalation study in the Phase 1/2 XIRIUS trial were presented at the EURETINA 2018 Congress. XIRIUS is a Phase 1/2, open-label, dose-ranging, single-eye clinical trial consisting of a dose escalation study and an expansion study with sites in both the U.S. and the U.K. The XIRIUS trial is intended to evaluate the safety, tolerability and efficacy of NSR-RPGR for the treatment of XLRP in patients with the RPGR mutation. Available safety data from the 15 treated patients in cohorts 1-5 indicates that NSR-RPGR was well-tolerated. The safety profile in the dose escalation study is generally consistent with that of surgical vitrectomy procedures and what has been observed in clinical trials of other ocular gene therapies. No serious adverse events related to treatment were reported and no early discontinuations or dose limiting toxicity were observed. Mild drug-related inflammation that potentially dampened efficacy was seen in the treated eyes of cohorts 4-5, with treatment efficacy observed to have been rescued in patients who received additional steroid treatment. Adverse events of varying severity and duration related to the vitrectomy procedure or drug have been observed in the dose escalation study such as retinal changes, intraocular inflammation and visual disturbances. The Data Monitoring Committee reviewed preliminary safety data for cohorts 1-5 and recommended escalation to cohort 6. The DMC also has not restricted pediatric enrollment in either the dose escalation study or expansion study. Based on the totality of results to date, Nightstar expects to initiate enrollment of the expansion study in the XIRIUS trial in the fourth quarter of 2018. The expansion study is intended to enroll approximately 30 adult and pediatric patients at a therapeutic dose informed by the dose escalation study and a low-dose control group of approximately 15 patients. Preliminary efficacy data from the expansion study is expected to be available in mid-2019, with one-year follow-up data expected to be available in 2020.