Medgadget » Cardiac Surgery

Draeger Infinity Acute Care System Coming to North America

Gene Ostrovsky — Wed, 23 May 2012 16:27:31 +0000

Dräger is bringing its Infinity Acute Care System, an advanced ICU monitoring package, to the U.S. and Canada. The system features a wireless patient monitor that stays attached to the bed, allowing for quick movement of patients between different clinical departments without ever losing live data feeding back to the central console.

The Infinity includes Masimo’s complete rainbow SET noninvasive Pulse CO-Oximetry, interfaces with Dräger’s ventilators, and the “Medical Cockpit” integrates the data with information from the EMR including diagnostic images and patient history.

OrbusNeich’s Combo Dual Therapy Stent Continues to Show Promise in Clinical Trial

Brian Klein — Tue, 22 May 2012 16:08:33 +0000

In November 2011, we reported the preliminary results of the REMEDEE clinical trial for the Combo Dual Therapy stent from OrbusNeich (Hoevelaken, Netherlands). The stent was developed to promote endovascular healing and cut the risk of restenosis compared to current bare-metal and drug-eluting stents. The randomized REMEDEE trial (Randomized Evaluation of an abluMinal sirolimus coatED bio- Engineered stEnt) found that the Combo Dual Therapy stent was non-inferior to the TAXUS Liberté paclitaxel-eluting stent based on in-stent late lumen loss at nine months.

More recently, at EuroPCR 2012, the company has announced the 12-month follow-up from the study. Data from that study indicate that the stent was associated with favorable clinical and safety outcomes over the TAXUS Liberté stent.

Five Questions for Dr. Paul Walker of Spectral Diagnostics

Jan Sinnige — Thu, 17 May 2012 18:40:40 +0000

Sepsis is a huge problem, costing billions of dollars and hundreds of thousands of lives a year in the US alone. A Toronto, Canada-based startup Spectral Diagnostics Inc. is developing a promising technology to decrease morbidity and mortality of patients with sepsis. The company’s proprietary technology is integrated into Toraymyxin, a hemoperfusion adsorption column which is highly effective in removing circulating endotoxin from the bloodstream. Furthermore, Spectral Diagnostics has also developed the Endotoxin Activity Assay (EAA) – the only FDA cleared, CE marked rapid diagnostic for endotoxemia. According to a company representative, in 2009 interim results of a Phase II study were published in JAMA demonstrating that “Toraymyxin, when added to conventional therapy, significantly reduced 28-day mortality in patients with severe sepsis and septic shock, compared to patients only receiving conventional therapy. Due to these positive results, that trial was terminated early and a Phase III pivotal multicenter study has been launched in the U.S. and Canada.” To find out more about this technology and its future, we had a chance to conduct an interview with Dr. Paul Walker, President and CEO of Spectral Diagnostics.

Dr. Jan Sinnige, Medgadget: Spectral Diagnostics recently started a phase three randomized controlled trial on Polymyxin B Hemoperfusion. What are the expectations according to the phase two results?

BIOTRONIK’s Lumax 740 ICD Debuts in the U.S.

Brian Klein — Mon, 14 May 2012 13:47:54 +0000

The FDA has approved the Lumax 740 implantable cardioverter defibrillators (ICD) and cardiac resynchronization therapy devices (CRT-D) from BIOTRONIK.

The Lumax 740 line, which was designed to help physicians monitor and treat arrhythmias and heart failure, features the company’s proprietary SMART Detection technology to reduce the incidence of inappropriate shocks to the heart.

BIOTRONIK’s Reocor External Pacemaker Now Available in U.S.

Gene Ostrovsky — Fri, 11 May 2012 20:13:09 +0000

BIOTRONIK is bringing to the U.S. the Reocor external pacemarker, that is available in two models for dual- and single-chamber pacing.

The company is touting the system’s design and intuitive controls, as well as a longer lasting battery that will work for 600 hours of permanent pacing on the Reocor S model.

Medtronic’s Valiant Captivia TAA Stent Now Available in U.S., Japan, China

Gene Ostrovsky — Wed, 09 May 2012 19:04:09 +0000

Medtronic is introducing its Valiant Captivia Thoracic Stent Graft in the U.S, China and Japan after receiving all the relevant regulatory clearances in those markets. The device, which received European approval back in October 2009, is indicated in the U.S. for “endovascular repair of aneurysms and penetrating ulcers of the descending thoracic aorta in patients with a non-aneurysmal aortic diameter in the range of 18–42 mm and non-aneurysmal aortic proximal and distal neck lengths ≥ 20 mm.”

The Valiant Captivia features eight peaks and troughs on each metal support ring, and by getting rid of the longitudinal connecting bar, such as on the company’s older Talent Thoracic Stent, the device is made more flexible and easier to apply inside tortuous aortas.

Boston Scientific’s Latest Bradycardia Pacemakers Get FDA OK

Gene Ostrovsky — Tue, 08 May 2012 12:54:42 +0000

Boston Scientific received FDA approval and is releasing in the U.S. the INGENIO and ADVANTIO pacemakers and INVIVE cardiac resynchronization therapy pacemakers (CRT-P).

The devices are indicated for treatment of bradycardia, and the INGENIO and ADVANTIO pacemakers specifically feature BostonSci’s RightRate technology for addressing chronotropic incompetence, a condition in which the heart is unable to regulate its rate appropriately in response to physiologic stress, such as an exercise.

Cameron Health’s Leadless Implatable Cardiac Defibrillator Looking to Get FDA Approval

Gene Ostrovsky — Tue, 01 May 2012 16:52:02 +0000

Cameron Health (San Clemente, CA), which was purchased in March by Boston Scientific, is reporting that the FDA’s Circulatory System Devices Panel has recommended approval for its S-ICD system, an implantable defibrillator that unlike traditional ones does not use intracardiac leads. Instead, an electrode implanted vertically under the skin on the chest senses the heart’s electrical signals and corrects them with appropriate shocks.

Though the recommendation for approval points to a likely final clearance of the device by the US FDA, the latest study of the S-ICD system did show it generates more unnecessary shocks, leads to more infections, and loses battery life faster than traditional ICDs. According to Bloomberg wire’s Apr 23, 2012 article, “Cameron Health also is working with the FDA to understand the root cause of premature battery depletion in the device. The FDA won’t consider approval until the issue is resolved, according to the report. The panel won’t weigh the battery issue.”

GE’s New Vivid E9 Breakthrough 2012 Ultrasound with 4D TEE Probe

Gene Ostrovsky — Mon, 30 Apr 2012 21:16:01 +0000

GE Healthcare just received FDA clearance for and is bringing to market its new Vivid E9 Breakthrough 2012 (BT12) cardiovascular ultrasound system.

The new system includes a 4D transesophageal echocardiography (TEE) transducer, allowing for its use during invasive surgical procedures, as well as minimally invasive procedures in the cath lab.

BIOTRONIK’s Evia HF-T, World´s First MR Conditional CRT-P System

Gene Ostrovsky — Mon, 30 Apr 2012 15:14:20 +0000

BIOTRONIK is releasing in Europe the Evia HF-T cardiac resynchronization therapy (CRT-P) implant, the first such device to be compatible with an MRI environment.

Like many of BIOTRONIK’s current devices, the Evia HF-T works with the company’s Home Monitoring and features Heart Failure Monitor, systems that transmit patient and device data for physician review.