Details from the press release:

Compared with conventional light sources, the smaller LEDs of the Polaris system are considerably more energy-efficient than conventional light sources. An LED light source has a life span of about 30,000 hours (corresponding to about seven to ten years of service life in the operating room), while the life span of a conventional light source is about 1,000 hours (corresponding to about four months of service life in the operating room). The slight amount of lost heat from the LEDs is dispensed through the top of the housing.

The different Polaris models are distinguished by their illuminating power. They can be used as an individual OR light or as a satellite in multiple-light systems, and can also be equipped with an integrated camera.

This new product design received the red dot design award 2008 which, according to the Design Zentrum Nordrhein Westfalen, is based on criteria such as innovation, functionality, quality and ergonomics.

The 108 light-emitting diodes of the Polaris (700 model) distribute light with a color temperature of 4,600 Kelvin. "Cold light" (without long-wave infrared content) is generated by means of a phosphor layer on the semiconductor and focused via an optical system. The LEDs are installed in the reflectors in pairs.

The individual light paths form a light cylinder which has an illumination depth of about 1,100 millimeters and a variable diameter of 220 to 290 millimeters. This ensures that the light of each LED can be focused on the OR field and that several surgeons can work simultaneously on the OR field without noticeably reducing the brightness.

Press release: Precision lighting with the new Dräger Polaris...

Product brochure... (.pdf)

Our friends over at MassDevice report on the findings:

Data collected from a 50-patient trial aimed at winning CE Mark approval in the European Union (which was granted in January) showed a six-month survival rate of 90 percent, according to a regulatory filing. Two years after implantation the survival rate was 84 percent. Patients 60 years and older had a survival rate of 93 percent.

The study also showed an 80 percent reduction in post-implantation re-hospitalizations in the 12 months after the procedure, compared with the 12 months preceding implantation.

More from MassDevice...

Link: HeartWare regulatory filings at the SEC...

Product page: HeartWare® Ventricular Assist System...

Flashback: Medical Heart Pumps from HeartWare: HVAD, MVAD and PedVAD

From the press release:

The GuideLiner is a unique coaxial “mother and child” guide extension with rapid exchange convenience that provides back-up support and selective deep intubation in challenging coronary interventions. The GuideLiner catheter will be available in 6, 7 and 8 French sizes as part of Vascular Solutions’ specialty catheter product line. CE mark clearance of the GuideLiner was received and European sales and clinical uses commenced in October, with the U.S. launch of the GuideLiner catheter expected to commence in November through Vascular Solutions’ direct sales force.

Dr. Douglas Fraser, an Interventional cardiologist with Manchester Heart Centre in Manchester, United Kingdom, commented on his initial clinical experience with the GuideLiner: “Deep intubation of the Guideliner catheter within a soft 6F guide provides better backup support and is less traumatic than using stiff 7F and 8F guides that were previously required in complex disease. Furthermore, the soft and very flexible tip will often cross tortuous disease where a stent gets stuck, enabling delivery of stents and other equipment directly to the target lesion. The GuideLiner is as easy to insert as a standard rapid exchange balloon catheter and has quickly become a routine part of my angioplasty practice.”

Dr. Colm Hanratty, an interventional cardiologist at Belfast City Hospital in Belfast, Ireland, commented on one of his initial clinical uses of the GudieLiner: “In this patient, despite modification of the diseased segment and subsequent pre-dilatation, we could not track a 3.0 mm stent across the lesion due to significant friction in the proximal vessel. We then passed a 6F GuideLiner into the vessel and by removing the proximal resistance we could then deliver the 3.0 mm stent, followed by a 4.0 mm stent and post-dilatation with a 4.0 mm balloon. Deep intubation with the Guideliner facilitated delivery, allowed us to optimize stent apposition and also improved visualization of the vessel due to selective cannulation.”

Press release (.pdf)...

Product brochure: GuideLiner Catheter...

Product page: GuideLiner Catheter ...

The controller unit is plug-and-play with easy start-up. Its compact size saves table space and the simple controls eliminate the need for lengthy training. The controller is completely silent since it does not require a cooling fan. All video settings are preprogrammed, so no complicated and time consuming set-up is necessary. A single cable leads from the controller to the ergonomic handpiece. The handpiece includes the tip deflection lever, working channel port, suction valve, and buttons for taking photos and illumination adjustment. High-powered LEDs are incorporated inside the handpiece. These LEDs eliminate the need for costly replacement bulbs.

Link: Innovative New Video Bronchoscope with DeepVu Technology ...

(hat tip: German Healthcare Export Group)

All patients underwent cardiac catheterization with the intention of implanting the artificial valve, and 30 of the 34 underwent actual implantation attempts, of which 29 were successful. Three patients (9 percent) had complications during implantation, but all survived.

At follow-up six months later, no patient had more than mild pulmonary regurgitation. Of 24 patients who had Class II or III heart failure (mild to moderate limitation of physical activity) before the procedure, 19 had improved by at least one functional class at six months, and no patient's function had declined.

Eight of the 29 devices developed partial fractures during follow-up, and 3 patients required a second Melody valve (inserted inside the first one) for recurrent blockage.

Children's Hospital Boston press statement: Catheter-delivered Valve May Help People with Heart Defects Avoid Multiple Surgeries; Medtronic statement: Melody® Transcatheter Valve Demonstrates Encouraging Results in Study on Patients with Congenital Heart Disease...

Abstract in Journal of the American College of Cardiology: Implantation of the Melody Transcatheter Pulmonary Valve in Patients With a Dysfunctional Right Ventricular Outflow Tract Conduit ...

Product page: Melody® Transcatheter Pulmonary Valve and Ensemble® Transcatheter Delivery System ...

Flashbacks: Medtronic's Melody Transcatheter Pulmonary Valve on Track for Approval ; Melody Transcatheter Pulmonary Valve Still Being Tested in the US ...; The Melody Valve Approved in Canada; The Melody Transcatheter Pulmonary Valve

The Trumpf OR table has been designed especially for this integration and is equipped with a onepiece carbon tabletop, which can be replaced by a segmented universal tabletop. The table column enables the two tops to be exchanged easily. The carbon tabletop is transparent to X-rays and thus ensures that there will be no disruptive artifacts in the images. It is suitable for interventional procedures and minimally invasive surgery. The integration of the OR table with the Siemens angiography systems also make fast rotations and 3-D imaging possible with the surgical C-arm. The modular design of the segmented tabletop enables extremely flexible positioning of the patient, particularly important in orthopedics and neuro surgery. Complicated positions, such as the chest side position, can be achieved quickly with great precision as well as comfort for the patient and staff.

Along with the integrated Trumpf OR table, Siemens continues to offer its Artis tables for the entire Artis zee series, which are available in three designs: as a standard table, a table with Trendelenburg tilting and one with Trendelenburg and lateral tilting.

Press release: Siemens integrates Trumpf's OR table in its Artis zeego and Artis zee ceiling angiography systems...

Product pages: TruSystem 7500, Artis zee, Artis zeego

Medgadget has obtained the following details about the device:

Featuring patent pending innovative thumb activation independent mechanisms, PMD’s ThumBlade™ safety scalpels enable one-handed activation smoothly and safely by right or left handed practitioners with no contact with the exposed blade. This activation affords an easy, natural opening motion while keeping the other fingers out of the way. The safety sheath is made from high quality ABS composite with a completely flat and smooth top, providing a stable platform for better control during the procedure. The extra sharp blades are stainless steel, pre-sterilized, and disposable after single use. The blade sheaths and packaging are color coded by size for easy counting and safe use. The stainless steel handles are pre-sterilized for first use and can be re-sterilized and re-used. These handles, available in both #3 and #4 fitments, are premium length and back-weighted for the grip and feel practitioners prefer.

Product page: ThumBlade™ safety scalpel system...

“The new fleet of Companion Drivers will supplement the 36 ‘Big Blue’ hospital drivers currently in use, more than tripling implant capacity by year-end,” said Rodger Ford, SynCardia CEO and President. “The Companion Driver will also supply the drivers we need to train the backlog of transplant centers waiting to become certified on the Total Artificial Heart.”

Proven Process Medical Devices, one of the largest medical Original Equipment Manufacturers in the world, has committed to producing 85 Companion Drivers by year-end, in addition to Hospital Carts for the OR/ICU and portable caddies for stable patients.

The Companion Driver is also designed to power SynCardia’s future family of pulsatile devices, including the 50cc Total Artificial Heart and the 10cc, 30cc and 60cc ventricular assist devices (VADs).

In October, SynCardia submitted a Pre-Market Approval Supplement to the FDA for approval of the Companion Driver in the U.S.

Press release: SynCardia's Companion Driver System Receives CE Mark to Power Total Artificial Heart in Europe...

Flashback: A New Driver System for CardioWest Artificial Heart

From Abiomed's press office:

USpella [is] the first U.S. multicenter registry of Impella 2.5 patients evaluating the safety and feasibility of left ventricular support with the Impella 2.5 during high-risk percutaneous coronary intervention (PCI) and treatment of acute myocardial infarction (AMI).

High-Risk PCI patient results in USpella

In 64% of the high-risk PCI cases, the patients had been turned down for CABG before treated with Impella 2.5

The high-risk PCI population presented with a more complex anatomy than the SYNTAX trial population (of 23), decreasing SYNTAX score from 38 to 18 after effective revascularization with Impella 2.5

Registry results reaffirmed ejection fraction increases that were similar to PROTECT I results, with improved ejection fraction in USpella high-risk PCI patients increasing from 29 to 34, after Impella 2.5 support

Reported overall MACE was low at 6%

30-day survival rate was 97%

AMI patient results in USpella

Impella was used after conventional therapies failed, (88% after emergent revascularization; 88% after high-dose inotropes; 68% after IABP therapy

Impella improved hemodynamics in AMI shock patients, improving cardiac index from 1.9 to 2.5 l/min/m2, increasing mean arterial pressure from 62 to 87 mmHg, and decreasing wedge pressure from 28 to 20 mmHg, as well as decreasing overall Systemic Vascular Resistance (SVR)

After Impella 2.5 support, overall ejection fraction in AMI patients improved from 29 to 37%;

Impella successfully supported AMI refractory shock patients with 69% survival to the next therapy or onto recovery. Also, 58% of AMI shock patients and 89% of AMI patients with no shock were discharged

The MACH II trial, evaluating safety and feasibility in STEMI, included 20 patients; ten patients were treated with three days of Impella 2.5 support; ten control patients were treated with routine standard of care. The initial four-month results, which demonstrated significant recovery of left ventricular function in Impella 2.5 patients, were published in the Journal of American College of Cardiology in 2008.

All patients were measured in an IRB-approved protocol that calculated echo results, exercise testing and quality of life, and showed the following results from core laboratory analysis and strict processes:

Left ventricular ejection fraction in Impella 2.5 patients increased from 28% at the baseline, to 41% in the four-month analysis, to 51% at the three-year follow-up period. Left ventricular ejection fraction in the control patients increased from 40% at the baseline, to 45% after the four-month analysis to 47% at the three year analysis. Impella 2.5 patients continued to show improvement in left ventricular ejection fraction, demonstrating a net increase of 23 ejection fraction points while control patients only showed a net increase of 7 ejection fraction points.

Significant benefit in exercise capacity was demonstrated stronger by Impella 2.5 patients, than control patients, which also improves the quality of life for the patient

Impella 2.5 patients saw no effects on aortic valve at three-year follow-up

Press releases: Abiomed Presents Results from USpella; First U.S. Registry Data Evaluating 181 Patients from 16 Centers with IRB Approval...; Abiomed Reports Results from Academic Medical Center's Three-Year Follow-up of MACH II Trial...

More thoughts from MassDevice...

Flashbacks: Impella 2.5 Heart Pump Performs Well in a Feasibility Trial; FDA OK'es Impella 5.0 and Impella LD Circulatory Assist Devices; Impella 2.5 Heart Pump Given Green Light in US; Impella Percutaneous VAD to be Studied for Acute MI Patients; impella® recover LV

LifeBond's technology functions through the rapid and biocompatible in situ cross-linking of structural proteins. As they cross-link, proteins in the physiological environment undergo a process of gelation to form an adhesive hydrogel matrix. The properties of the cross-linking reaction and the hydrogel matrix can be controlled to fit a variety of applications.

LifeSeal GI is comprised of LifeBond sealant provided in a specialized two-component applicator syringe. The mixed sealant is applied to anastomosis staple-line junctures in the GI tract to fortify the attachment and prevent leakage until full function is restored. The applicator thoroughly mixes the two components as they are applied and evenly dispenses the sealant onto the staple-line juncture. The sealant can be applied manually or as a gas-assisted spray.

Application of LifeSeal GI onto the staple line moderates tension on the staple line because it stabilizes the tissue sections in relation to each other and adds adhesive strength to the junction. Furthermore, LifeSeal GI seals off the staple holes and narrows the spaces in between each staple. Thus, leakage, bleeding, and tearing at the staple line can be reduced, especially in diseased and fragile tissue.

LifeSeal Surgical sealant is provided in a variety of specialized two-component applicators. The mixed sealant is applied to a wound site or staple-line juncture to prevent fluid or blood leakage until full physiological function is restored. The applicator thoroughly mixes the two components as they are applied and evenly dispenses the sealant onto the wound site or staple-line juncture. The sealant can be applied manually or as a gas-assisted spray. The precise application method can be altered to optimize sealant use for specific applications.

Links: Lifebond technology page; LifeSeal SLR; LifeSeal Surgery

(hat tip: ISRAEL21c)