The pilot study of an extravascular implantable cardiac defibrillator developed by Medtronic (NYSE:MDT), which is designed to deliver both defibrillation and anti-tachycardia pacing using leads placed outside the heart and venous system, showed strong safety and efficacy results.
The safety outcome for the 26-patient study, presented last week at the annual meeting of the Heart Rhythm Society in San Francisco, was the rate of freedom from major complications at three months. The efficacy measure was the inducement, detection and conversion of ventricular fibrillation episodes; patients were followed at two weeks, four to six weeks and three months after implantation.
Of the 21 patients implanted with the EV ICD device, defib testing was complete on 19, with successful inducement and termination in 17 or 89.5%, and a more than 95% rate of pacing capture. One episode of ventricular tachycardia outside the hospital was successfully detected and treated by the device, Medtronic said.
“The successful pilot study revealed valuable insights to inform our EV ICD clinical program and we are eager to incorporate the learnings from this study into a pivotal trial,” Cardiac Rhythm and Heart Failure CMO Dr. Rob Kowal said in prepared remarks. “Medtronic appreciates the contributions of the investigators and patients and we are proud to lead the way in ICD innovation for patients who need protection from life-threatening heart rhythms.”
“I am very encouraged by our pilot experience using the Medtronic EV ICD system in patients out to three months,” added principal investigator Dr. Ian Crozier of New Zealand’s Christchurch Hospital. “This small but important study affirms the potential of this new extravascular approach to provide pacing and lifesaving defibrillation therapy without the risks that accompany transvenous leads implanted inside the heart and veins.”
Boston Scientific’s Emblem S-ICD fares well in primary prevention study
A 1,116-patient study of primary prevention using BSX’s Emblem S-ICD device in patients with left ventricular ejection fractions of 35% or less showed a 95.8% rate of freedom from complications, a 99.6% rate of successful implantation at 30 days and an 99.2% rate of successful defbrillator conversion.
“The data presented today reiterate the value of the Emblem S-ICD System for a broad group of ICD-indicated patients, enabling them to avoid the long-term complications associated with TV-ICD leads,” global health policy & rhythm management CMO Dr. Kenneth Stein said in prepared remarks. “We remain proud of the clinical success of the S-ICD System, which has now been implanted in nearly 60,000 patients worldwide, and we will continue to invest in clinical studies that advance our understanding of the role of the device in patients at risk of sudden cardiac death.”
“We found that the complication rate within this primary prevention population was as low as in prior S-ICD registries, despite the patients having much lower LVEF, more hypertension, and diabetes – underscoring that sicker patients do well with this device for the prevention of sudden death,” added principal investigator Dr. Lucas Boersma of Holland’s St. Antonius Hospital. “These acute outcomes also validate the advantages of the two-incision implant technique, which has continued to gain worldwide adoption in the last few years.”
CardioFocus touts HeartLight X3 study
CardioFocus said a study of the latest iteration of its visualization and ablation catheter, the HeartLight X3, cut procedure times by mroe than 90 minutes and showed comparable safety and efficacu compared with the first-generation device.
“CardioFocus is experiencing tremendous growth; more than 6,500 patients have been treated with our revolutionary HeartLight system and the HeartLight X3 system is poised to make a real impact on the AFib ablation space with its recent CE Mark approval,” president & CEO Burke Barrett said in prepared remarks. “We believe coupling the HeartLight System’s unique feature set and its safety and effectiveness profile with the straightforward introduction of X3 Rapid mode for accelerating procedures, will result in an unparalleled PVI ablation tool.”
“Our trial results using the HeartLight X3 System were outstanding, with the study meeting all the pre-specified endpoints,” added lead investigator Dr. Petr Neužil of Prague’s Na Homolce Hospital. “With faster PVI and faster total ablation times combined with the already established safety and efficacy of the current HeartLight System, I anticipate that the HeartLight X3 System will be quickly adopted in the clinical setting.”
Javelin Medical’s Vine embolic coil passes FIH feasiblity study
An embolic coil developed by Javelin Medical to reduce the risk of stroke in Afib patients who can’t take anti-coagulant drugs passed a first-in-human feasibility study.
The Vine device is designed to be placed transcutaneously into both common carotid arteries to trap debris that mioght travel downstream and cause a stroke. The 25-patient feasibility study had a safety endpoint of the rate of major adverese events and an efficacy endpoint of procedural success, both at 30 days.
The Capture study showed a 0% rate of major adverse events and a 20% rate of minor AEs, consisting of five cases of puncture site hematoma and/or edema. The procedural success rate was 92% at 30 days. After six months there was no evidence of in situ clot formation and the filter captured clots in four patients, which were dissolved with heparin. One patients suffered two minor strokes from clots outside the carotid arteries.
“These promising data should prompt large prospective randomized trials,” according to the study’s authors.
- Promising one-year outcomes for AFTx’s real-time rotor mapping algorithm
- MediLynx touts micro-AF monitoring as predictor
- Preventice Solutions touts long-term cardiac monitoring with BodyGuardian device
- J&J’s Biosense Webster launches Cartonet
- Spacelabs debuts Sentinel 11 software
- Medtronic: Studies show CRM devices are underused
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
Join Shultz and 1,000+ medical device professionals at the 8th annual DeviceTalks Boston.