Biotronik wins FDA nod for Acticor, Rivacor high-voltage tachycardia devices

Biotronik logo

Biotronik said yesterday it won FDA approval for its Acticor and Rivacor high-voltage cardiac rhythm management devices intended for treating patients with cardiac arrhythmias.

The clearance covers the Berlin, Germany based company’s Rivacor VR-T, Rivacor DR-T, Rivacor HF-T QP, Acticor DX, Acticor CRT-DX Bipolar and Acticor CRT-DX devices.

“When determining the best treatment plan for each patient, we assess individual needs and select a device system that provides optimal therapy programming with critical diagnostic features. We are often forced to choose between important features, which could compromise optimal patient care. The approval of Acticor and Rivacor offers choices to avoid this compromise. Intelligent software built into these devices enables us to assess disease states and respond accordingly with flexibility and customization. These devices offer sophisticated programming and automation as well as longer battery life, smaller size, and greater MRI access (3 Tesla). Our hope is that this will be a significant advance in device therapy and empower us to improve patient care while reducing long-term risk,” cardiac electrophysiologist Dr. Larry Chinitz said in a prepared statement.

Biotronik said that its Acticor and Rivacor systems include more diagnostic and therapeutic capabilities in a smaller form factor with extended battery longevity, and added that both devices have 3 Tesla MR-conditional labeling. Both systems are also equipped with the company’s home monitoring technology which Biotronik claims reduces all-cause mortality due to heart failure by 60%.

“Simplifying care through exceptional diagnostics and automated therapy is another example of how Biotronik continues to help physicians provide unmatched patient care. The Acticor and Rivacor device systems reflect Biotronik’s commitment to engineering solutions with profound positive impact for patients, physicians and health systems. We remain focused on bringing cardiac solutions to the US market that streamline processes and improve the ability to deliver care without compromise. There isn’t anything on the market that compares to Acticor and Rivacor,” prez Ryan Walters said in a press release.

Last month, Biotronik said that it won FDA approval for its for its Orsiro drug-eluting stent, touting it as the first and only ultrathin DES to outperform Abbott‘s (NYSE:ABT) Xience.

The post Biotronik wins FDA nod for Acticor, Rivacor high-voltage tachycardia devices appeared first on MassDevice.

Biotronik wins FDA nod for Orsiro DES

Biotronik logo

Biotronik said today that it won FDA approval for its for its Orsiro drug-eluting stent, touting it as the first and only ultrathin DES to outperform Abbott‘s (NYSE:ABT) Xience.

The Berlin, Germany-based company said that the approval came based on data from the BIOFLOW-V pivotal trial of the device. Results from the study indicated a significantly lower rate for target lesion failure and target vessel myocardial infarction at 12 months as compared to Xience in a large, complex patient audience.

Read the whole story on our sister site, Drug Delivery Business News

The post Biotronik wins FDA nod for Orsiro DES appeared first on MassDevice.

Statistical error reverses noninferiority finding in head-to-head trial of DES, bioresorbable scaffold

OrsiroIn a reversal, investigators for a trial comparing Biotronik‘s bioresorbable, drug-eluting Orsiro stent and Biosensors‘ BioFreedom drug-eluting stent reported this week that Biosensors’ device did not meet the criteria for noninferiority.

The researchers said that while preparing the study for publication in a journal, they discovered a statistical error that ultimately changed the trial’s conclusion. The results were first presented earlier this year at the 2018 Transcatheter Cardiovascular Therapeutics meeting.

Get the full story at our sister site, Drug Delivery Business News.

The post Statistical error reverses noninferiority finding in head-to-head trial of DES, bioresorbable scaffold appeared first on MassDevice.

Biotronik receives FDA approval for covered coronary stent

 

biotronik-pk-papyrus

[Image from Biotronik]

Biotronik has received FDA approval for its PK Papyrus covered coronary stent system.

The PK Papyrus coronary stent system is a balloon-expandable covered stent that is placed in the coronary artery using a balloon catheter delivery system. The stent system is designed to treat tears in heart blood vessels, known as coronary artery perforations. It is manufactured from cobalt-chromium metal alloy and covered with a polyurethane membrane.

Get the full story on our sister site, Medical Design & Outsourcing.

The post Biotronik receives FDA approval for covered coronary stent appeared first on MassDevice.

EuroPCR Roundup: Biotronik touts two-year study comparing drug-eluting stents

Biotronik yesterday presented two-year data from a trial comparing Boston Scientific‘s (NYSE:BSX) Synergy biodegradable polymer everolimus-eluting stent, Biotronik’s Orsiro sirolimus-eluting stent and Medtronic‘s (NYSE:MDT) Resolute Integrity zotarolimus-eluting stent.

Results from the 3,514-patient trial showed no significant difference between the various stents regarding the rate of target vessel failure after two years. But analyses of one-year data found differences between the rates of target lesion revascularization and target lesion failure for patients treated with Orsiro compared to Resolute Integrity, according to Biotronik.

Get the full story at our sister site, Drug Delivery Business News.

Next >>

The post EuroPCR Roundup: Biotronik touts two-year study comparing drug-eluting stents appeared first on MassDevice.