The annual Transcatheter Cardiovascular Therapeutics conference went down in Washington, D.C., this week, with late-breaking study results beginning Oct. 29.
After stents took center stage Day 1, with a raft of studies covering the latest on the bioresorbable front, transcatheter valve replacements were the focus on Day 2. Day 3 saw a wider variety of topics, featuring big-name devices for structural heart repair and peripheral artery disease at the Transcatheter Cardiovascular Therapies conference.
Below is a roundup of miscellaneous releases from the conference:
Freudenberg Medical launches new products
Freudenberg Medical said it launched a trio of new technologies at TCT 2016: The FlexSeal introducer sheath, FlexSeal hemostasis valve and the Composer deflectable catheter handle platform.
“These innovative devices are for companies looking to 1) accelerate time to market with a unique white-label device, 2) access new design options for improving next generation catheter and delivery systems, or 3) reduce time when building new feature sets into products,” Freudenberg said. Read more
Shockwave Medical touts Disrupt CAD study, announces plans for Disrupt PAD III
Shockwave Medical reported positive safety, performance and intravascular imaging data from its Disrupt CAD study and revealed its plans for the Disrupt PAD III trial, claiming it as the largest-ever multi-center randomized study of patients with calcified peripheral artery disease.
InspireMD reveals 12-month CGuard data
InspireMD (NYSE:NSPR) revealed 12-month follow up data from the Paradigm-101 trial of its CGuard embolic prevention system in a pair of presentations, “Twelve-month Safety and Efficacy of CGuard Micronet-Covered Embolic Prevention Stent System” and “Highly Calcific Carotid Lesions Endovascular Revascularizaton Using a Novel Dual-layer Carotid Stent System CGuard.” Read more
Elixir Medical drops 6-month data from Desolve Cx study
Elixir Medical announced 6-month data for the first 25-patient subset of its Desolve Cx study showing late lumen loss of 0.18 ± 0.29mm, no cases of scaffold thrombosis and no clinically-driven major adverse cardiac events. Read more
Backbeat Medical shows 1-year data from anti-hypertension pacer
BackBeat Medical presented data demonstrating a continued significant reduction in blood pressure over 1 year with its Moderato pacemaker. The 35-patient study showed that systolic blood pressure remained low at 1 year with an average reduction of 13.9mmHG. No significant difference was observed between the change at 3 months and 1 year. In the 13 patients who reached 18 months and the 10 patients who reached 24 months, the effect was maintained with respective average reductions of 18.7 and 19.7mmHg. Read more
Mitralign posts 30-day Scout I results for Trialign tricuspid repair device
Mitralign presented 30-day data from its Scout I study of its Trialign device for tricuspid valve repair. The data from a 15-patient cohort showed 100% acute implant success, no deaths and no major adverse events through 30 days, as well as statistically significant improvements in TV annulus area (from 12.3 ± 3.1cm2 to 11.3 ± 2.7cm2), PISA EROA (from 0.51 ± 0.2cm2 to 0.32 ± 0.2cm2), 6-minute walk test (from 236.5m ± 107.4 to 305.1m ± 106.5) and Minnesota Living with Heart Failure Score (from 49.6 ± 15.7 to 18.8 ± 12.0). Read more
Amaranth Medical presentation of the 9-month clinical and imaging results from the company’s FORTITUDE® sirolimus-eluting bioresorbable scaffold (BRS)62 patients YY Read more
Amaranth Medical touts 9-month results for Fortitude bioresorbable stent
Amaranth Medical presented 9-month clinical and imaging results from a 62-patient study of its sirolimus-eluting bioresorbable scaffold and announced plans for another study of its latest-generation Magnitude sirolimus-eluting BRS, which has a strut thickness in the sub-100-micron range.
Cardiovascular Systems announces plans for 2,000-patient Eclipse study
Cardiovascular Systems (NSDQ:CSII) debuted the design of its new Eclipse orbital atherectomy trial, saying it plans to enroll as many as 2,000 subjects at up to 60 U.S. sites. Half will receive orbital atherectomy prior to drug-eluting stent implantation and the other half will receive conventional angioplasty, including specialty balloons, followed by DES implantation. The study is powered to demonstrate differences in the primary endpoints of post-procedural minimal cross-sectional area (assessed by intravascular imaging in a subset of up to 400 patients) as well as in the clinical outcome of target vessel failure at 1 year. CSI said it expects to begin recruiting patients in spring 2017. Read more
Neovasc details Tiara TMVR program, updates on Reducer
Neovasc presented an update on its ongoing Tiara transcatheter mitral valve replacement program, including data on the 19 patients treated with the Tiara valve showing a 30-day survival rate of 84%. Enrollment is ongoing in the Tiara-I early feasibility study and other compassionate use programs. Neovasc also presented data from the Cosira study of its Reducer device for treating refractory angina and outlined the design of the 380-patient Cosira II pivotal U.S. study. Read more