Atmo Biosciences Ltd. is gearing up for pivotal trials of its ingestible gas-sensing capsule after a clinical study supported the gas capsule’s ability to determine its location in the gastrointestinal tract.
Boston Scientific Corp. and Abbott Laboratories continue to parry over clinical trials comparing the latter’s Amplatzer Amulet with Boston Scientific’s Watchman in sealing the heart’s left atrial appendage (LAA) to prevent ischemic stroke in patients with atrial fibrillation (Afib). In one of five presentations at the 34th Transcatheter Cardiovascular Therapeutics annual scientific symposium in Boston in mid-September, Abbott said device-related thrombosis or peri-device leak more frequently preceded strokes in patients with Watchman compared to those with Abbott’s Amplatzer Amulet device.
In recent years, ethicists have executed a 180-degree shift on including children in clinical trials testing drugs, biologics and medical devices, moving from the idea that it was unethical to include youngsters in trials to an understanding that such inclusion may be the best way of protecting them.
Volta Medical SAS reported validation for its VX1 software mapping system, an artificial intelligence (AI) algorithm compatible with most commonly available multi-pole catheters and technology used in operating rooms and cath labs for treating cardiac arrhythmia. Results from the proof-of-concept-study were published in the Journal of Cardiovascular Electrophysiology.
Aggressive prostate cancer disproportionately affects—and kills—African American men, but identifying which men are at highest-risk has proved challenging, particularly in younger patients. Veracyte Inc.’s Decipher prostate genomic classifier could help identify these men with early, localized prostate cancer at the greatest risk of aggressive disease, a new study published in the Journal of the National Cancer Institute found.
The 2022 Transcatheter Cardiovascular Therapeutics annual meeting highlighted mostly positive outcomes from major trials conducted by nearly all the big players in the cardiac device market. Here’s our round-up of the meeting’s high points, with updates from Abbott Laboratories, Abiomed Inc., Boston Scientific Corp., Edwards Lifesciences Corp., Inari Medical Inc., Medtronic plc and Recor Medical Inc.
Transcatheter aortic valve replacement (TAVR) continues to grow, so it is little surprise that the 2022 Transcatheter Cardiovascular Therapeutics (TCT) annual meeting featured multiple presentations about TAVR-related devices and outcomes. The American College of Cardiology/American Heart Association’s latest guidelines recommends TAVR for patients over age 80 and surgery for those under age 65. Those in the middle can go either way, depending on comorbidities and patient preferences.
Abiomed Inc., has worked the ventricular assist device (VAD) space for a number of years with its Impella series of VADs, and a study coming out of Japan seems to affirm investors’ confidence in these devices. This registry study demonstrated that the combination of Impella devices and extracorporeal membrane oxygenation (ECMO) provides a 30-day survival rate of more than three in four patients with cardiogenic shock, an outcome that is said to support the notion that the native heart tissue can recover from myocarditis, an especially salient consideration for those who contracted the SARS-CoV-2 virus.
In an unexpected turn of events, Medtronic plc presented results from the Symplicity HTN-3 trial at year 3 showed sustained reductions in blood pressure with radiofrequency renal denervation (RDN) for resistant hypertension, contrary to the trial’s results at the six-month mark—and it wasn’t alone in showing positive results for the procedure.
Inari Medical Inc. released results from its 800-person Flowtriever All-Comer Registry for Patient Safety and Hemodynamics (FLASH) registry in pulmonary embolism (PE) at the 2022 Transcatheter Cardiovascular Therapeutics conference in Boston on Sept. 18 showing that treatment of PE with its Flowtriever device provided immediate hemodynamic and symptom improvement with all-cause mortality rates under 1.0% at 30 days.
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