Biotronik Smallest MR Conditional Pacing Lead Available in the United States

Biotronik announced the commercial launch of Solia S ProMRI®, with a 5.6 French lead body, the smallest MR conditional pacing lead available in the United States. Solia S ProMRI is available in 45, 53 and 60 centimeter lengths.

   

Solia received Food and Drug Administration (FDA) approval on June 9, 2016 based on data collected during the Pre-Market Study (IDE) phase of the SIELLO clinical study. All Pre-Market Study primary safety and efficacy endpoints were met with statistical significance:
Primary endpoint one: 100 percent 12-month event-free rate for patients with an atrial Solia lead
Primary endpoint two: 99.6 percent 12-month adverse event-free rate for patients with a ventricular Solia lead
Primary endpoint three: 100 percent rate of successful sensing and pacing at 12 months for patients with one or two
Solia leads

The SIELLO clinical study enrolled 1,758 patients at 60 US sites with 3,220 implanted Solia leads.

“BIOTRONIK has a long-standing history of providing reliable leads without recall. Nearly 600,000 BIOTRONIK leads of this product family have been implanted worldwide. We’ve built a reputation that physicians can trust,” said Marlou Janssen, President, BIOTRONIK, Inc. “We invest significantly in innovation, but never at the expense of safety or reliability. BIOTRONIK enrolls more patients in lead studies than any other global CRM device company. We make this investment because physicians and patients deserve that level of confidence.”

With a polyurethane coating over silicone designed to reduce friction, Solia enables easier introduction through small vessels and complex anatomy. Solia’s soft distal segment is designed to help reduce stress and minimize myocardial trauma.

“Because there is a wide range of patient anatomy types, it is necessary to have various lead lengths to ensure the best outcomes. There have been, however, limitations in the variety of leads available, so this new technology will offer a more versatile lead and improve procedures,” said Ulrika Birgersdotter-Green, MD, director of pacemaker and ICD services at UC San Diego Health and professor of medicine at University of California, San Diego School of Medicine.

A press release can be found from Biotronik website.

FDA Approves MR Conditional Tachycardia Devices from Biotronik

Biotronik announced Food and Drug Administration (FDA) approval of Iperia ProMRI HF-T, a cardiac resynchronization defibrillator that provides heart failure patients with access to diagnostic magnetic resonance imaging (MRI) scans. Iperia devices also have remote monitoring with daily automatic transmission and closed loop stimulation (CLS) that adapts the heart rate in response to physiological demands.

Iperia HF-T was developed with BIOTRONIK’s ProMRI, Home Monitoring, and CLS technology, creating an advanced cardiac resynchronization therapy defibrillator (CRT-D) designed to support each patient’s unique healthcare journey. BIOTRONIK’s MR conditional tachycardia devices ensure patients have access to 1.5T scans without an exclusion zone. Home Monitoring provides automatic daily transmission of data relating to arrhythmic events and heart failure statistics, which have been shown to reduce all-cause mortality by more than 50 percent. For heart failure patients, early detection of deterioration reduces patient mortality.

“The FDA approval of Iperia HF-T demonstrates the shift that is happening in cardiovascular patient care,” said Marlou Janssen, President, BIOTRONIK, Inc. “BIOTRONIK now offers a comprehensive portfolio of MR conditional ICDs. We’re driving the standard of care to new levels by providing physicians and hospitals with innovative, reliable, cardiac devices that ensure patients have access to imaging technology critical to diagnosing and treating future illness and injury. This is technology that is making a difference in patients’ lives.”

A press release can be found by following this link.

Boston Scientific Receives FDA Approval For MR-Conditional Pacing System

Boston Scientific has received U.S. Food and Drug Administration (FDA) approval for a suite of products deemed safe for use in a magnetic resonance imaging (MRI) environment. The ImageReady™ MR-Conditional Pacing System, which includes ACCOLADE™ MRI and ESSENTIO™ MRI pacemakers, as well as the new INGEVITY™ MRI pacing leads, is designed to treat bradycardia, a condition in which the heart beats too slowly. Patients implanted with the full system are able to receive full-body MR scans in 1.5 Tesla environments when conditions of use are met.

The newly-approved family of INGEVITY MRI pacing leads includes active and passive fixation models. This marks the first time a passive fixation pacing lead is approved for U.S. patients undergoing MR scans.

Approval of the INGEVITY MRI leads, as well as the full ImageReady System, was based on data from two global clinical trials. The INGEVITY trial, a prospective, non-randomized study, enrolled 1,036 patients and assessed safety, performance and effectiveness of the leads in patients with a single or dual chamber pacemaker. The SAMURAI trial, a prospective, randomized study, enrolled 351 patients and evaluated safety and effectiveness of the ImageReady System for use in patients with a single or dual chamber pacemaker when used in an MRI environment.

The ImageReady System offers automatic daily monitoring via the LATITUDE™ NXT Patient Management System. An increasingly important tool for physicians, automatic daily monitoring has been shown to improve survival in patients with pacemakers1. The LATITUDE NXT wireless system allows for earlier intervention and improved patient outcomes by providing physicians with device and patient information through customizable alerts.

A press release can be found from Boston Scientific webstie following this link.

Profound Medical receives CE Mark for minimally invasive therapy in prostate care

Profound Medical announced that the company has received CE Mark approval for the commercial sale of TULSA-PRO.

“Our innovation and passion for this unique therapy has been recognized with the achievement of CE Mark. This is a major step forward in the growth of the company, facilitating the commercial launch of TULSA-PRO in Europe and other CE Mark jurisdictions. We expect this approval to be a catalyst for the adoption of our therapy, which has the potential to make a significant impact on the clinical community and, ultimately, patients being treated with TULSA-PRO,” said Steve Plymale, CEO.

Profound’s novel technology combines real-time Magnetic Resonance (MR) imaging with transurethral robotically-driven ultrasound and closed-loop thermal feedback control, providing a highly precise treatment tailored to patient-specific anatomy and pathology.TULSA-PRO has demonstrated accurate and precise ablation of prostate tissue, both malignant and benign, while providing a favourable safety profile and a low rate of erectile dysfunction.

Profound Medical GmbH, a subsidiary of Profound Medical Corp., has been established in Hamburg, Germany to support European commercial operations. The commercial launch of TULSA-PRO in Europe and other CE Mark jurisdictions will commence immediately.

Product information can be found from Profound Medical website by clicking here.

St. Jude obtains CE approval for MRI Compatible Nanostim Leadless Pacemaker

St. Jude announced CE Mark approval for magnetic resonance (MR) conditional labeling for 1.5 T scans for the company’s Nanostim™ leadless pacemaker. With the approval, throughout Europe both existing patients implanted with a Nanostim leadless pacemaker and new patients receiving a Nanostim leadless pacemaker in the future can safely undergo full-body MRI diagnostic scans.

Product information could be found from this link.

Further news: FDA Approves World's Smallest yet Leadless Pacemaker