Endotronix raised $3 million and is looking to bring in another $540,000 in a new round of debt financing, according to an SEC filing posted last week. Woodridge, Ill.-based Endotronix develops wireless cardiac monitors, including a ‘tiny pressure sensor’ designed to be implanted in a patient’s pulmonary artery during a catheterization procedure, to wirelessly return PA […]
Cardiac Implants
FDA clears Biotronik’s full-body MRI-safe Iperia ICDs
Biotronik said last week it won FDA premarket approval for its Iperia family of magnetic resonance imaging-compatible implantable cardioverter defibrillators. The approval includes Biotronik’s Iperia DR-T DF-1 and DF4 configurations, the Iperia DX and Iperia ProMRI DX, the company said. “Our goal is to integrate ProMRI technology across our entire line of implantable systems, and […]
Biotronik wins 2 FDA clearances: Iperia MRI-safe ICD and Astron peripheral stent
Biotronik said today it won FDA premarket approval for its latest family of MRI compatible implantable cardioverter defibrillators and won another premarket approval for its Astron peripheral self-expanding stent system. The company’s ProMRI ICD portfolio approval includes the DF-1 and DF4 configured Iperia DR-T, the Iperia Dx hybrid ICD and the Inventra ProMRI Dx which […]
Canada clears Medtronic Evera MRI SureScan ICD
Medtronic (NYSE:MDT) said today it won license approval from Health Canada for its Evera MRI-compatible SureScan implantable cardioverter defibrillator system. The Evera MRI SureScan ICD is licensed for MRI scans when needed on any part of the body, according to Fridley, Minn-based Medtronic. The licensing includes both the Evera MRI ICD and Sprint Quattro Secure MRI […]
Xeltis snags $3.2m extension for Series B, closes round with $32m
Xeltis said today it brought in an extra $3.2 million (EU €3 million) extension for its Series B financing round, bringing the total up to $32.4 million (€30 million) for its bioabsorbable cardiovascular valve platform. Xeltis’ is designing a platform of bioabsorbable cardiovascular valves and vessels, starting with the pulmonary valve, designed to allow endogenous […]
Svelte Medical granted CE Mark for Slender IDS drug-eluting stent catheter
Svelte Medical Systems said today it won CE Mark approval in the European Union for its Slender sirolimus-eluting coronary stent-on-a-wire integrated delivery system designed to treat coronary artery disease. The Slender IDS is the lowest-profile drug-eluting stent on the market, according to the New Providence, N.J.-based company. Approval in the EU came based on data […]
Study: Boston Scientific’s Watchman cheaper than drugs in reducing afib stroke risk
A study comparing the stroke risk for atrial fibrillation patients treated with Boston Scientific‘s (NYSE:BSX) Watchman device with the anticoagulant drug warfarin and non-warfarin oral anticoagulants found Watchman to be more cost-effective than its counterparts. Watchman is a catheter-delivered cardiac implant designed to close off the left atrial appendage, to prevent blood clots from forming there that could […]
BioVentrix pulls in $14m in funding round, touts pre-clinicals
BioVentrix raised $14 million in a new round of equity funding and said it performed the 1st implantation of its micro-anchor Revivent device in a pre-clinical model. The Revivent treatment is a transcatheter-based procedure known as less invasive ventricular enhancement that reduces the overall size of the wall of the heart’s left ventricle, without the […]
St. Jude wins CE Mark for MR-safe Quadra Assura CRT-D
St. Jude Medical (NYSE:STJ) said today it won CE Mark approval in the European Union for MRI-conditional labelling for its Quadra Assura cardiac resynchronization therapy defibrillator. The Quadra Assura CRT-D is compatible with MRI scanning systems up to 1.5 Tesla, St. Paul, Minn.-based St. Jude said. “The Quadra Assura CRT-D MRI allows patients to continue to […]
Report: Medicare proposal would broaden coverage for Boston Scientific’s Watchman
The Centers for Medicare & Medicaid Services are reportedly considering broadening the coverage for Boston Scientific‘s (NYSE:BSX) Watchman anti-stroke device, according to an unidentified official with the federal health insurer. Leerink Partners analyst Danielle Antalffy, citing a Bloomberg report, wrote today that the CMS official “clarified that CMS is proposing to pay for Watchman for a subset […]
Analysts: Worst case unlikely in Medicare call on Boston Scientific’s Watchman anti-stroke device
The worst-case Medicare reimbursement scenario for Boston Scientific‘s (NYSE:BSX) Watchman anti-stroke device is unlikely to play out, according to a pair of analysts. Boston Scientific shares took a hit earlier this month after the Centers for Medicare & Medicaid Services proposed to limit coverage for the Watchman device, a transcatheter implant designed to seal off the left atrial appendage to […]